Ex Parte Tower et al

Patent Trial and Appeal Board

May 17, 2013

10127969 (P.T.A.B. May. 17, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte ALLEN J. TOWER,
PHILIPP BONHOEFFER,
and MICHAEL L. MARTIN
__________

Appeal 2012-000815
Application 10/127,969
Technology Center 3700
__________

Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
SHERIDAN K. SNEDDEN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to a delivery
system for percutaneously implanting a heart valve prosthesis. The
Examiner rejected the claims as failing to comply with the written
description requirement and as obvious. We have jurisdiction under 35
U.S.C. § 6(b). We affirm.
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Statement of the Case
Background
The Specification teaches “to improve percutaneous deliver systems
for placing a biological venous valvular replacement for a defective valve
within an implantation site” (Spec. 2, ll. 5-7).
The Claims
Claims 46-55, 67-73, and 86-92 are on appeal. Claim 46 is
representative and reads as follows:
46. A delivery system in combination with a heart valve
assembly, the delivery system for percutaneously implanting the
heart valve assembly in an implantation site within a heart of a
patient, the heart valve assembly comprising an expandable metal
stent and a valve mounted inside the stent, the valve including a
biological component, the biological component being sutured to
the metal stent, the heart valve assembly comprising a
substantially tubular heart valve assembly with a plurality of
internal valve leaflets; the delivery system comprising:
an elongated catheter having a proximal end portion and a
distal end portion,
a passageway that is sized and shaped to slidably receive a
guide wire within at least a portion of the delivery system;
an elongated inflatable balloon associated with a distal end
portion of the delivery system, said balloon being connectable to
a device for inflating and deflating said balloon,
an elongate nose element that is at least partially located
distal to the balloon, the nose element having a leading tip at a
distal end, wherein the nose element is shaped to have an outer
surface of increasing diameter proximally from the leading tip
over at least a portion of the nose element and to provide a
portion of the nose element that is proximal from the leading tip
with a nose element outer surface that is sized for sliding along
an internal surface of a blood vessel during delivery of a heart
valve assembly to the implantation site, the nose element also
providing at least a portion of the passageway for slidably
receiving the guide wire;
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wherein the heart valve assembly is crimped to a collapsed
configuration onto the distal end of the delivery system so as to
be operatively positionable onto the balloon in a deflated state,
and further wherein the heart valve assembly is mounted to the
delivery system without extending substantially radially further
than the profile defined by the outer surface of the nose element
so that during delivery of the heart valve assembly through a
blood vessel, the nose element outer surface will slide along a
blood vessel with the heart valve assembly following behind and
substantially within the size and shape of the nose element,
the delivery system is capable of moving the heart valve
assembly from i) a collapsed configuration in which the heart
valve assembly is received on the delivery system in a shape
capable of being transported to an implantation site; to ii) an
expanded configuration suitable for implantation at the
implantation site.

The Issues
A. The Examiner rejected claims 88-91 under 35 U.S.C. § 112, first
paragraph as failing to comply with the written description requirement
(Ans. 4-5).
B. The Examiner rejected claims 46, 67, and 87-91 under 35 U.S.C. §
103(a) as obvious over Bevier
1
and Tower
2
(Ans. 5-8).
C. The Examiner rejected claim 49 under 35 U.S.C. § 103(a) as obvious
over Bevier, Tower, and Wijay
3
(Ans. 8-9).
D. The Examiner rejected claims 47, 48, 50-53, 68-73, and 86 under 35
U.S.C. § 103(a) as obvious over Bevier, Tower, and Chee
4
(Ans. 9-10).
E. The Examiner rejected claims 54, 55, and 92 under 35 U.S.C. § 103(a)
as obvious over Bevier, Tower, and Chee (Ans. 10-11).

1
Bevier et al., US 6,190,393 B1, issued Feb. 20, 2001.
2
Tower et al., EP 1,057,460 A1, published Dec. 6, 2000.
3
Wijay, B., US 5,643,278, issued Jul. 1, 1997.
4
Chee et al., US 5,906,606, issued May 25, 1999.
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A. 35 U.S.C. § 112, first paragraph – written description
The Examiner finds that “[c]laim 88 recites wherein the nose element
comprises a proximal portion that curvilinearly decreases in diameter.
However, the instant specification does not support this limitation. Claims
89-91 are dependent on claim 88 and therefore are also not supported by the
specification” (Ans. 4-5).
Appellants contend that “the curvilinear decrease in diameter of the
proximal portion of the nose element is clearly shown in FIGS. 1 and 2”
(App. Br. 24). Appellants contend that,
[f]or example, compare the curvature illustrated in the
encircled portions of nose cone 20 with the stepped decrease in
diameter between the proximal portion of catheter 12 and the
distal end of sheath 30. One of ordinary skill in the art
presented with these figures would appreciate that the proximal
portion of nose element 20 decreases curvilinearly in diameter
moving in the proximal direction

(id. at 25).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner‟s conclusion that the Specification does not support
the limitation for a nose element having a “proximal section having a
curvilinearly decreasing diameter from the first diameter along at least a
portion of the nose element” as required by claim 88?
Findings of Fact
1. The Specification teaches a “contoured nose cone [which]
enables the user to rapidly guide the catheter into a desired implantation site
and thus considerably shorten the implantation procedure when compared to
similar systems used in the art” (Spec. 4, l. 29 to 5, l. 2).
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2. Figures 1 and 2 of the Specification are reproduced below:

FIG. 1 is a perspective view illustrating a delivery system
embodying the teachings of the present invention for the
percutaneous insertion and implantation of a biological
replacement valve within a patient;
FIG 2. is a partial perspective view illustrating the distal
end of the system shown in Fig. 1 with its protective shield
moved back away from the balloon section of the system

(Spec. 3, ll. 5-10).
Principles of Law
“[P]atent drawings do not define the precise proportions of the
elements and may not be relied on to show particular sizes if the
specification is completely silent on the issue.” Hockerson-Halberstadt, Inc.
v. Avia Group. Int’l, Inc., 222 F.3d 951, 956 (Fed. Cir. 2000); see also In re
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Wright, 569 F.2d 1124, 1127 (CCPA.1977) (“Absent any written description
in the specification of quantitative values, arguments based on measurement
of a drawing are of little value.”).
Analysis
We have reviewed figures 1 and 2 in the locations indicated by
Appellants in their brief (see App. Br. 25) but do not see a clear indication of
a “proximal section having a curvilinearly decreasing diameter from the first
diameter along at least a portion of the nose element” as required by claim
88. While figures may be used for descriptive support, the “curvilinearly
decreasing diameter” feature is not clearly evident in the figures and the
Specification is silent regarding this “curvilinearly decreasing diameter.” We
find that the Examiner has the better position in finding lack of descriptive
support for the claimed element.
Conclusion of Law
The evidence of record supports the Examiner‟s conclusion that the
Specification does not support the limitation for a nose element having a
“proximal section having a curvilinearly decreasing diameter from the first
diameter along at least a portion of the nose element” as required by claim
88.
B. 35 U.S.C. § 103(a) over Bevier and Tower
The Examiner finds that
Bevier discloses a balloon delivery catheter for a vascular
implant. The device includes an elongated catheter (24)
having a passageway for slideably receiving a guide wire
(38), a tapered nose element (18), a balloon (16), a stent (14)
crimped to the balloon (column 4, line 20), a sheath (64),
and a protective shield (66) mounted on the distal end of the
sheath. . . . [T[he nose element is located distal of the
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balloon and the tapering of the distal end gives the element a
proximally increasing diameter. This shape allows the
proximal end of the nose element to have a larger outer
diameter than the stent to protect the stent when sliding
along an internal surface of a blood vessel

(Ans. 5-6). The Examiner finds that “Bevier fails to disclose the delivery of
a stent-heart valve, but does teach that various stents can be delivered by the
device” (id. at 6). The Examiner finds that “Tower teaches that a biological
stent-heart valve can be delivered by a balloon catheter. Similar to
Bevier, the prosthesis has been crimped onto the balloon for low profile
delivery” (id.).
The Examiner finds it obvious
to deliver the Tower stent-heart valve with the Bevier balloon
catheter, as this modification simply increases the versatility of
the Bevier delivery device by allowing the device to implant
both heart valves and stents. This combination advantageously
applies the use of a known technique, delivering a stent, to
improve similar devices in the same manner

(id.).
The issues with respect to this rejection are:
(i) Does the evidence of record support the Examiner‟s conclusion
that Bevier and Tower render the claims obvious?
(ii) If so, have Appellants presented evidence of secondary
considerations, that when weighed with the evidence of obviousness, is
sufficient to support a conclusion of non-obviousness?
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Findings of Fact
3. Bevier teaches
a direct stent delivery system for delivering and deploying a
stent. This stent delivery system preferably also provides
enhanced stent position retention, as well as stent protection,
during longitudinal movement of the catheter. The stent
delivery system also is preferably capable of traversing total
vessel occlusions, preferably having enhanced pushability and a
positive stent release mechanism

(Bevier, col. 3, ll. 25-33).
4. Figure 1 of Bevier is reproduced below:

“FIG. 1 is an external perspective view of a stent delivery system” (Bevier,
col. 3, ll. 44-45).
5. Bevier teaches that the “stent delivery system 10 illustrated in
FIG. 1 includes a balloon catheter 12, a stent 14 crimped around a deflated
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balloon 16, a flexible tapered introducer tip 18, and a sheath 20” (Bevier,
col. 4, ll. 17-20).
6. Bevier teaches that the “balloon catheter hub 22 provides a
maneuvering handle for the health care professional as well as an inflation
port 26 and a guidewire port 28” (Bevier, col. 4, ll. 26-28).
7. Bevier teaches that the “stent depicted in the drawings is a
cylindrical metal stent having an initial crimped outer diameter, which may
be forcibly expanded by the balloon to a deployed diameter” (Bevier, col. 6,
ll. 54-56).
8. Bevier teaches that the stent delivery system
may be inserted percutaneously along a guidewire and
within an outer guiding catheter (not shown), until the
guiding catheter distal end reaches the vicinity of the desired
site. The stent delivery system is then advanced wherein the
stent delivery system as shown in FIG. 6 until the stent
covered by the sheath is positioned within the lesion 74.
The sheath is then partially retracted to uncover the
stent as in FIG. 7. The balloon is inflated as in FIG. 8 to
expand the stent, and the stent delivery system is removed
from the patient‟s body as in FIG. 9, leaving the stent
implanted at the desired site.

(Bevier, col. 7, ll. 2-13.)

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9. Figures 6-9 of Bevier are reproduced below:

“FIG. 6 is a partial side elevational view of the stent delivery system . . .
advanced to a desired position; FIG. 7 is a . . . view . . . in which the sheath
is partially retracted to uncover the stent; FIG. 8 is a . . . view . . . in which
the balloon is inflated to expand the stent; FIG. 9 is a . . . view . . . after
removal of the stent delivery system” (Bevier, col. 3, l. 60 to col. 4, l. 2).
10. Bevier teaches a “flexible tapering introducer tip 18, adapted to
help cross and traverse lesions or stenoses. . . . [T]he stent delivery system
10 of the present invention instead tapers up to a much larger profile
diameter, equal to the largest outer diameter of the sheath 20, which is
slightly greater than the outer diameter of the crimped stent 14 itself”
(Bevier, col. 5, ll. 34-49).
11. Bevier teaches that in “the case of coronary direct stenting this
preferred outer introducer tip 18 profile may range from about 0.047 to as
much as 0.063, which is much greater than the diameter of the inner tube 34
distal profile. Indeed, the maximum diameter of the present introducer tip 18
may be more than twice that of the inner tube 34” (Bevier, col. 5, ll. 49-54).
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12. Bevier teaches that the “introducer tip 18 further defines a tip
guidewire lumen 32 and a larger opening for receiving the distal end of the
balloon catheter shaft inner body 34. . . . The flexibility of the introducer tip
18 should be optimized to enable the stent delivery system 10 to accurately
follow the guidewire 38 without causing prolapse” (Bevier, col. 6, ll. 8-11).
13. Bevier teaches that the “distal tip tapers gradually up to an outer
diameter preferably equal to the largest outer diameter of the entire system,
and tends to gently widen any particularly narrow stenosis” (Bevier, col. 3,
ll. 1-4).
14. Bevier teaches that to
improve efficiency and reduce time required for the vascular
procedure, it is desirable to combine these two procedures,
angioplasty and stent deployment. . . . Several benefits may be
realized by employing such a combined procedure, including
reduced time of the procedure, less intervention, and fewer
medical devices inserted into the patient‟s body

(Bevier, col. 2, ll. 4-11).
15. Tower teaches “a replacement cardiac valve assembly that
includes a biological valve which is attached to a radially intravascular stent,
the assembly being capable of percutaneous implantation into a body lumen
via balloon catheterization” (Tower 1 ¶ 0001).
16. Tower teaches that an “advantage of the replacement valve
assembly of the present invention is that a „natural‟ valve can be effectively
used and implanted without requiring open heart surgery” (Tower 3 ¶ 0019).
17. Tower teaches that “another advantage of the present invention
is that the described replacement valve assembly is at least as reliable while
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being far more inexpensive to manufacture to implant than previously
known valve assemblies” (Tower 3 ¶ 0020).
18. Tower teaches that:
The size and thickness of the biological bovine
material section, as initially harvested, is somewhat larger
than that needed to permit provide an effective passageway
when attached to the stent 14 to implant the assembly 10.
Therefore, portions of the harvested section must first be
trimmed in order to remove extraneous material. Sufficient
material must remain, however, to allow the biological valve
18 to be fitted as an impermeable membranous layer for the
mesh-like stent 14.

(Tower 6 ¶ 0033.)
19. Tower teaches that the “biological valve 18 is then sutured to
the interior of the radially expandable intravascular stent 14” (Tower 6 ¶
0035).
20. Tower teaches that “[f]ollowing attachment to the catheter 20,
the replacement valve assembly 10 is percutaneously implanted after a guide
wire (not shown) has first been guided to the area of interest, for example
through the femoral artery. The replacement valve assembly 10 is then
implanted over the guide wire” (Tower 7 ¶ 0038).
21. Dr. Bonhoeffer
5
teaches that
Medtronic has received clearance from the U.S. Food and Drug
Administration to market the Medtronic Melody Transcatheter
Pulmonary Valve and the Ensemble Delivery System products
under a Humanitarian Device Exemption (HDE). This would
make the Melody valve and its delivery system the very first
transcatheter delivered tissue valve authorized for commercial
sale in the United States

5
Declaration of Dr. Philipp Bonhoeffer, filed November 19, 2010.
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(Bonhoeffer Dec. 3 ¶ 8).
22. Dr. Laske
6
teaches that
over 900 human cases have been reported using the Melody
Transcatheter Pulmonary Valve and Ensemble Transcatheter
Delivery System. While not every case is a perfect clinical
success and there have in fact been adverse events such as stent
fractures associated with Medtronic‟s system, it is entirely fair
to characterize this product line as a success both clinically and
commercially

(Laske Dec. 8/10/09 4 ¶ 9).
23. Dr. Laske teaches that “[s]ales of the Melody valve and
Ensemble delivery system have also been brisk since its CE mark approval.
Last fiscal year, Medtronic sales of the Melody Transcatheter Pulmonic
Valve and Ensemble Delivery System were approximately $9,890,464.00
million dollars” (Laske Dec. 8/10/09 7 ¶ 15).
24. Dr. Laske teaches that “there is a clear link between the claimed
invention and the commercialized product enjoying the critical acclaim and
the commercial and clinical success” (Laske Dec. 8/10/2009 7 ¶ 16).
25. Palacios
7
teaches that “[r]ecently, percutaneous transcatheter
replacement of the pulmonic valve was introduced by Bonhoeffer et al.
(4,5), and percutaneous valve replacement of calcific aortic stenosis was
introduced by Cribier et al. (6,7). This pioneering work by these two
investigators represents a milestone that opens a new era of interventional
cardiology (4-7)” (Palacios 1662, col. 2). Citations 4 and 5 in Palacios relate

6
Declaration of Dr. Timothy Gerard Laske, filed August 10, 2009.
7
Palacios, I., Percutaneous Valve Replacement and Repair, 44 J. AMERICAN
COLLEGE CARDIOLOGY 1662-1663 (2004).
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to papers including Bonhoeffer as an author published in 2000 and 2002 (see
Palacios 1663, col. 2).
26. Davidson
8
(referred to as Baim by the Laske Declaration)
teaches that:
The first human percutaneous pulmonary valve
replacement was performed by Bonhoeffer et al. [38] in
2000 using a bovine jugular valve mounted in a self-
expanding stent . . . Given the overall clinical success of this
approach and the morbidity associated with reoperative
surgery, percutaneous pulmonary valve replacement is the
most likely of all the catheter-based valve technologies to
achieve near-term broad clinical application.

(Davidson 127, col. 2.)
27. Babaliaros
9
(referred to as Block by the Laske Declaration)
teaches “implantation in a 12-year-old boy with previously repaired
pulmonary atresia and ventricular septal defect [3]. . . . Since then, this valve
(Medtronic, Minneapolis, Minn., USA), with some mild design
improvements, has been implanted in over 100 patients (fig. 6), and the
experience reported in the first 88 patients is encouraging [59, 63,
64]” (Babaliaros 93, col. 2).

8
Davidson et al., Percutaneous therapies for valvular heart disease, 15
CARDIOVASCULAR PATHOLOGY 123-129 (2006).
9
Babaliaros et al., State of the Art Percutaneous Intervention for the
Treatment of Valvular Heart Disease: A Review of the Current Technologies
and Ongoing Research in the Field of Percutaneous Valve Replacement and
Repair, 107 CARDIOLOGY 87-96 (2007).
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28. Hijazi
10
teaches that Dr. Bonhoeffer received the PICS 2006
Achievement Award which “is given to an individual who contributed a lot
to the moving field of Pediatric and Congenital Interventional Cardiology”
(Hijazi, col. 1).
29. Hijazi teaches that Dr. Bonhoeffer‟s
biggest contribution to medicine came in 1999, when he
developed the valve that we all know, the Melody, in
collaboration with NuMED and now with Medtronic. He
implanted the first valve in a 12-year old child Sept 2000 in
Paris. This was the first ever-percutaneous valve to be
implanted in a living human heart. This of course bas paved
the way for the implantation of percutaneous valves in the
aortic position pioneered by Alain Cribier and others.

(Hijazi, col. 2.)
30. Dr. Bonhoeffer also received the Lefoulon-Delalande
Foundation 2006 Science Prize, with the press release stating that:
Professor Philipp Bonhoeffer, Chief of Cardiology and
Director of the Catheterisation Laboratory at GOSH, and
Professor Francis Fontan, were awarded for their pioneering
work in paediatric cardiology. Professor Bonhoeffer was
recognised in particular for his work on trans-catheter valve
implantation, currently considered to be the most exciting
advance in interventional cardiology and estimated to
benefit over 100,000 patients each year worldwide. . . .
Professor Bonhoeffer‟s research into replacing a heart valve
without open-heart surgery began in 1999. Within just 18
months, the application of his new technique had been
approved in humans, and in September 2000 he performed
the world‟s first human heart valve implantation without
surgery, on a 12-year old boy.

10
Hijazi, Z., PICS 2006 Achievement Award Was Presented to . . .,
SYMPOSIUM DAILY FOR CONGENITAL CARDIOLOGY TODAY, Day 3, p. 1
(2006).
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(Press Release 1.)
Principles of Law
“In proceedings before the Patent and Trademark Office, the
Examiner bears the burden of establishing a prima facie case of obviousness
based upon the prior art.” In re Fritch, 972 F.2d 1260, 1265 (Fed. Cir.
1992).
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “If a person of
ordinary skill can implement a predictable variation, § 103 likely bars its
patentability.” Id. at 417.
“[E]vidence rising out of the so-called „secondary considerations‟
must always when present be considered en route to a determination of
obviousness.” Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1538 (Fed.
Cir. 1983).
Analysis
Prima facie obviousness
Bevier teaches a deliver system for percutaneously implanting a stent
prosthesis in an implantation site comprising introducing a stent assembly
supported at a distal end portion of a catheter in a blood vessel for
advancement toward an implantation site (FF 3, 8). Bevier teaches that the
catheter which includes a passageway for a guidewire (FF 6), an elongated
inflatable balloon that expands between collapsed and expanded positions
(FF 5, 7, 8), includes a elongated nose element distal to the balloon which
provides a passageway for a guide wire (FF 10-12), and a flexible steerable
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component operatively connected with the tip (6). Bevier teaches an
expandable metal stent (FF 7).
Bevier teaches a distal nose tip that is as at least a large as the stent
assembly, teaching that the “distal tip tapers gradually up to an outer
diameter preferably equal to the largest outer diameter of the entire system,
and tends to gently widen any particularly narrow stenosis” (Bevier, col. 3,
ll. 1-4; FF 13).
Bevier teaches advancing the assembly to the desired location using
the steerable component (FF 6, 8) which may include movement through
bends (FF 10), and inflating the balloon to expand the stent, deflating the
balloon and removing the catheter (FF 8).
The Examiner finds that “Bevier fails to disclose the delivery of a
stent-heart valve, but does teach that various stents can be delivered by the
device (column 6, lines 47-60)” (Ans. 6).
Tower teaches “a replacement cardiac valve assembly that includes a
biological valve which is attached to a radially intravascular stent, the
assembly being capable of percutaneous implantation into a body lumen via
balloon catheterization” (Tower 1 ¶ 0001; FF 15).
Applying the KSR standard of obviousness to the findings of fact, we
conclude that the person of ordinary creativity would have predictably
modified Tower‟s valve-stent assembly to use the catheter system of Bevier
since Bevier teaches that to
improve efficiency and reduce time required for the vascular
procedure, it is desirable to combine these two procedures,
angioplasty and stent deployment. . . . Several benefits may be
realized by employing such a combined procedure, including
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reduced time of the procedure, less intervention, and fewer
medical devices inserted into the patient‟s body
(Bevier, col. 2, ll. 4-11; FF 14). Thus, the ordinary artisan interested in
percutaneous implantation of Tower‟s stent would have selected Bevier‟s
system in order to reduce the time of the procedure, the intervention
required, and the number of medical devices being inserted into the patient.
In addition, the ordinary artisan would have been motivated to
incorporate Tower‟s assembly into Bevier‟s percutaneous deployment
system since Tower teaches that an “advantage of the replacement valve
assembly of the present invention is that a „natural‟ valve can be effectively
used and implanted without requiring open heart surgery” (Tower 3 ¶ 0019;
FF 16). Tower teaches that “another advantage of the present invention is
that the described replacement valve assembly is at least as reliable while
being far more inexpensive to manufacture to implant than previously
known valve assemblies” (Tower 3 ¶ 0020; FF 17). Thus, the ordinary
artisan would have been motivated to incorporate Tower‟s system of stent-
valve replacement into Bevier‟s stent deployment system in order to avoid
open heart surgery. Such a combination is a “predictable use of prior art
elements according to their established functions.” KSR, 550 U.S. at 417.
Appellants contend that the
design of the Bevier device delivers an expandable stent to a
target lesion along the vasculature . . . . There is no disclosure
of advancing any portion of this vasculature delivery system
into the heart. . . . Moreover, the system is not designed for
implantation in the heart. On this basis alone, Bevier is
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deficient as a primary reference regardless of the attempted
modifications based on Tower
(App. Br. 15). Appellants contend that “one of ordinary skill in the relevant
art would have started with a delivery system concept such as disclosed by
Tower EP” (id. at 16).
We are not persuaded. The issue is whether the combination of
Bevier and Tower jointly render the claims obvious, not whether Bevier
alone is sufficient to anticipate the claims or whether Tower would have
been a better selection as a primary reference. As already discussed above,
Bevier teaches percutaneous delivery of stents through the vasculature (FF
5-6), Tower teaches percutaneous delivery of a stent-valve assembly through
the vasculature and into the heart (FF 13, 18), and both references
suggesting advantages including avoidance of open heart surgery, cost
reduction, and reduced operation time (FF 12, 14, 15). “[W]here the relevant
factual inquiries underlying an obviousness determination are otherwise
clear, characterization by the examiner of prior art as „primary‟ and
„secondary‟ is merely a matter of presentation with no legal significance.” In
re Mouttet, 686 F.3d 1322, 1333 (Fed. Cir. 2012).
Appellants contend that “Schreck also teaches away from a delivery
system as disclosed in Bevier. One of ordinary skill in the art would not be
motivated to look to the delivery system of Bevier” (App. Br. 17).
We do not find the teaching away argument persuasive. A teaching
away requires a reference to actually criticize, discredit, or otherwise
discourage the claimed solution. See In re Fulton, 391 F.3d 1195, 1201 (Fed.
Cir. 2004) (“The prior art‟s mere disclosure of more than one alternative
does not constitute a teaching away from any of these alternatives because
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such disclosure does not criticize, discredit, or otherwise discourage the
solution claimed”). Appellants do not identify, and we do not find, any
teaching in the cited prior art which criticizes, discredits, or otherwise
discourages the incorporation of Tower‟s stent-valve assembly onto a
catheter system such as that of Bevier.
Appellants contend that “[t]here would have been no reasonable
expectation of success, therefore, to combine a stent system with that of a
heart valve prosthesis system” (App. Br. 18). Appellants contend that there
“is significant unpredictability involved in how to effectively load and
deliver a dramatically larger payload with additional functional and delicate
structural elements (leaflets) and in how to deliver and implant a heart valve
prosthesis to an annulus of the heart by way of the vasculature” (id. at 19).
We are not persuaded. An “obviousness finding was appropriate
where the prior art „contained detailed enabling methodology for practicing
the claimed invention, a suggestion to modify the prior art to practice the
claimed invention, and evidence suggesting that it would be successful.”‟ In
re Kubin, 561 F.3d 1351, 1360 (Fed. Cir. 2009) (citing In re O’Farrell, 853
F.2d 894, 902 (Fed. Cir. 1988). Here, Bevier provides detailed methodology
enabling percutaneous delivery of stents (FF 3-14) and Tower provides
detailed methodologies for percutaneous delivery of heart valve-stents
including the delicate leaflets (FF 15-20). Both Bevier and Tower provide
reasons which would have motived the combination including reduced cost,
avoidance of open heart surgery, reduced medical equipment (FF 14, 16,
17). The court commented that “[r]esponding to concerns about uncertainty
in the prior art influencing the purported success of the claimed
combination, this court [in O’Farrell] stated: „[o]bviousness does not require
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absolute predictability of success ... all that is required is a reasonable
expectation of success.”‟ Kubin, 561 F.3d at 1360 (citing In re O’Farrell,
853 F.2d at 903-904). Here, there is a reasonable expectation of success
since these were known methods of delivery of stents, and the combination
would simply combine the assembly of Tower into the delivery system of
Bevier.
Appellants contend that the “combination is deficient and does not
disclose the method of claim 67 with respect to the claimed nose element
and the relevant sizing aspect with respect to the nose element and the heart
valve prosthesis as they are advanced along the vasculature to an
implantation site of the heart” (App. Br. 20).
We are not persuaded. This argument conflicts with the express
teaching of Bevier that the “preferred outer introducer tip 18 profile may
range from about 0.047 to as much as 0.063, which is much greater than the
diameter of the inner tube 34 distal profile. Indeed, the maximum diameter
of the present introducer tip 18 may be more than twice that of the inner tube
34” (Bevier, col. 5, ll. 49-54; FF 11). Indeed, Bevier teaches that the “distal
tip tapers gradually up to an outer diameter preferably equal to the largest
outer diameter of the entire system, and tends to gently widen any
particularly narrow stenosis” (Bevier, col. 3, ll. 1-4; FF 13). Thus, Bevier
expressly teaches that the distal tip (i.e. nose tip) is preferably sized to be
larger than the outer diameter of the largest other component of the system
(FF 11). We agree with the Examiner that the artisan of ordinary skill and
creativity would rescale “the Bevier nose cone tip so that is also able to
protect the compacted stent-valve (noting that a person of ordinary skill in
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the art is also a person of ordinary creativity and not an automaton)” (Ans.
12).
We therefore conclude that the Examiner has established a prima facie
case of obviousness based on the teachings of Bevier and Tower.
Secondary Considerations
In analyzing the obviousness analysis in light of secondary
considerations, the Federal Circuit requires “that a fact finder must consider
all evidence of obviousness and nonobviousness before reaching a
determination.” In re Cyclobenzaprine Hydrochloride Extended-Release
Capsule, 676 F.3d 1063, 1077 (Fed. Cir. 2012).
Appellants contend that “Professor Bonhoeffer detailed that the
invention is a recognized significant advance in medicine by the medical
community and that the invention solved a long-felt problem, among other
benefits. See generally Bonhoeffer Declaration” (App. Br. 21). Appellants
contend that “the claimed invention enjoys commercial success, the claimed
invention faced initial skepticism by others, and that it has enjoyed general
acclaim by others” (id.).
We address these secondary considerations in turn, before analyzing
them together with the evidence of obviousness presented by the Examiner.
Long-felt need
To establish a long-felt need, three elements must be proven: First, the
need must have been a persistent one that was recognized by ordinarily
skilled artisans. In re Gershon, 372 F.2d 535, 538 (CCPA 1967). Second, the
long-felt need must not have been satisfied by another before Appellants‟
invention. See Newell Companies, Inc. v. Kenney Mfg. Co., 864 F.2d 757,
768 (Fed. Cir. 1988) (“[O]nce another supplied the key element, there was
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no long-felt need or, indeed, a problem to be solved . . . .”). Third, the
invention must, in fact, satisfy the long-felt need. In re Cavanagh, 436 F.2d
491, 496 (CCPA 1971).
Appellants do not identify any specific finding or teaching of long-felt
need in the Bonhoeffer Declaration (see App. Br. 21).
Commercial Success
There are three pieces of evidence of record regarding commercial
success. The first is that Medtronic received approval from the U.S. Food
and Drug Administration to market the device under a humanitarian
exemption (FF 21). While FDA approval may be relevant, it does not
demonstrate a secondary consideration of commercial success. The second
and third pieces of evidence are that 900 devices were implanted (FF 22) and
these resulted in sales of approximately 10 million dollars in sales (FF 23).
However, the Laske Declaration “provides no indication of whether
this represents a substantial quantity in this market. This court has noted in
the past that evidence related solely to the number of units sold provides a
very weak showing of commercial success, if any.” In re Huang, 100 F.3d
135, 140 (Fed. Cir. 1996). Further, even assuming that Appellants have
sufficiently demonstrated commercial success, that success
is relevant in the obviousness context only if there is proof
that the sales were a direct result of the unique
characteristics of the claimed invention-as opposed to other
economic and commercial factors unrelated to the quality of
the patented subject matter. . . . In other words, a nexus is
required between the sales and the merits of the claimed
invention.

Id. at 140. Here, Dr. Laske does state that “there is a clear link between the
claimed invention and the commercialized product enjoying the critical
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acclaim and the commercial and clinical success” (Laske Dec. 8/10/2009 7 ¶
16; FF 24). However, there is no evidence showing that the success is due to
the unique features of the product rather than advertising or marketing, price
or other factors.
Skepticism
Appellants identify no support for the secondary consideration of
skepticism by others in the Appeal Brief, nor do we find such evidence in
the Bonhoeffer Declaration (see App. Br. 21).
Praise by Others
The Bonhoeffer Declaration identifies several types of praise, such as
statements in the art, statements by Medtronic employees, and prizes
received by Dr. Bonhoeffer (see Bonhoeffer Dec 3-4 ¶¶ 9-10). Dr.
Bonhoeffer notes that “My colleagues in the medical community recognize
the Melody valve and its delivery system as a significant advance in
medicine and have heaped praise on this work” (Bonhoeffer Dec 3-4 ¶ 9).
Dr. Bonhoeffer notes “I was also awarded a number of prizes at least in part
for my work on the Melody and Ensemble products which reflect the
recognition and high regard of the medical community for this work”
(Bonhoeffer Dec 4 ¶ 10).
The first type of praise is based on statements identified in the Laske
Declaration by Palacios (FF 25), Davidson (referred to as Baim by the Laske
Declaration) (FF 26), and Babaliaros (referred to as Block by the Laske
Declaration) (FF 27). Palacios praises both Dr. Bonhoeffer and Dr. Cribier,
citing work performed by Dr. Bonhoeffer in 2000 and 2002 (FF 25).
Davidson praises work done by Dr. Bonhoeffer in 2000 (FF 26). Babaliaros
notes that any changes were “mild design improvements” with “encouraging
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results” (FF 27). There is no evidence in Palacios, Davidson, or Babaliaros
which demonstrates that the praise by Palacios, Davidson, or Babaliaros is
directed at the currently claimed invention, or to any particular feature of the
currently claimed invention, rather than to Dr. Bonhoeffer‟s previous
iteration of a stent-valve assembly disclosed in Tower, or some other
embodiment. “A nexus is required between the merits of the claimed
invention and the evidence offered, if that evidence is to be given substantial
weight enroute to conclusion on the obviousness issue.” Stratoflex, 713 F.2d
at 1539. While Babaliaros did not identify the improvements, they were
characterized as “mild design improvements” (FF 27).
Another type of praise is found in the Laske Declaration itself, which
states that “I agree with Dr. Hellenbrand (who, upon information and belief,
is a paid consultant for Medtronic) when he states, „The Melody valve is an
enormous breakthrough and an enormous relief - for patients with congenital
heart disease.‟” (Laske Dec. 8/10/2009 3 ¶ 8.) Since Dr. Hellenbrand and Dr.
Laske are interested parties, employed by the real party in interest
Medtronic, we consider their praise with that fact in mind.
A third type of praise is based upon prizes received by Dr.
Bonhoeffer. Dr. Bonhoeffer received the PICS 2006 Achievement Award
which “is given to an individual who contributed a lot to the moving field of
Pediatric and Congenital Interventional Cardiology” (Hijazi, col. 1; FF 28).
Hijazi teaches that Dr. Bonhoeffer‟s
biggest contribution to medicine came in 1999, when he
developed the valve that we all know, the Melody, in
collaboration with NuMED and now with Medtronic. He
implanted the first valve in a 12-year old child Sept 2000 in
Paris. This was the first ever-percutaneous valve to be
implanted in a living human heart. This of course bas paved
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the way for the implantation of percutaneous valves in the
aortic position pioneered by Alain Cribier and others.

(Hijazi, col. 2; FF 29.) Dr. Bonhoeffer also received the Lefoulon-Delalande
Foundation 2006 Science Prize, with the press release stating that:
Professor Philipp Bonhoeffer, Chief of Cardiology and
Director of the Catheterisation Laboratory at GOSH, and
Professor Francis Fontan, were awarded for their pioneering
work in paediatric cardiology. Professor Bonhoeffer was
recognised in particular for his work on trans-catheter valve
implantation, currently considered to be the most exciting
advance in interventional cardiology and estimated to
benefit over 100,000 patients each year worldwide. . . .
Professor Bonhoeffer‟s research into replacing a heart valve
without open-heart surgery began in 1999. Within just 18
months, the application of his new technique had been
approved in humans, and in September 2000 he performed
the world's first human heart valve implantation without
surgery, on a 12-year old boy.

(Press Release 1; FF 30.)
While both prizes testify to Dr. Bonhoeffer‟s work, the evidence again
lacks a specific nexus to the claimed features of the invention. Indeed, both
awards specifically reference the implantation of the valve in 2000, and
there is no evidence teaching whether this valve was implanted using the
device and method disclosed in Tower or whether this valve was implanted
using the device and method of the instant claims.
In fact, Dr. Bonhoeffer‟s declaration implies that all of the praise
presented above was based on an earlier embodiment, such as shown in
Tower, rather than the device and method of the instant claims, when stating
that in 2009 “[w]e performed a successful first in man procedure of the new
device developed with Medtronic after obtaining regulatory approval from
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the MHRA on compassionate grounds” (Bonhoeffer Dec. 10). That the “new
device” was first implanted in humans in 2009 suggests that the 2000 valve
implantation cited by most of those praising Dr. Bonhoeffer utilized a prior
technology.
Conclusion
Weighing a reasonably strong prima facie case of obviousness with
the secondary consideration factors, long-felt need, commercial success,
skepticism in the art, and praise by others, where each factor either lacks any
supporting evidence or lacks evidence demonstrating a nexus with the
claimed invention, we conclude that the claimed invention is obvious in light
of the totality of the evidence. Cf. Transocean Offshore Deepwater Drilling,
Inc. v. Maersk Drilling, 699 F.3d 1340, 1354 (Fed. Cir. 2012).
Conclusion of Law
(i) The evidence of record supports the Examiner‟s conclusion that
Bevier and Tower render the claims obvious.
(ii) Appellants have not presented evidence of secondary
considerations, that when weighed with the evidence of obviousness, is
sufficient to support a conclusion of non-obviousness.
C. 35 U.S.C. § 103(a) over Bevier, Tower, and Wijay
The Examiner relies upon Bevier and Tower as discussed above, and
further relies upon Wijay for the rejection of claim 49. The Examiner finds
it obvious “to include index markings on the inner catheter of the modified
Bevier device, as taught by Wijay, since this provides the operator with
information regarding the position of the sheath” (Ans. 8-9).
The Examiner provides sound fact-based reasoning for combining
Wijay with Bevier and Tower. We adopt the fact finding and analysis of the
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Examiner as our own. Appellants provide no specific reasons regarding the
combination of Wijay with Bevier and Tower. Since we have found that
argument unpersuasive for the reasons given above, we affirm this rejection.
D. 35 U.S.C. § 103(a) over Bevier, Tower, and Chee
The Examiner relies upon Bevier and Tower as discussed above, and
further relies upon Chee for the rejection of claims 47, 48, 50-53, and 86.
The Examiner finds it obvious “to form the center lumen of the modified
Bevier catheter from metallic tubing, as Chee teaches that this improves the
mechanical properties of a balloon catheter by allowing the catheter to be
highly flexible but still very resistant to kinking” (Ans. 9).
The Examiner provides sound fact-based reasoning for combining
Chee with Bevier and Tower. We adopt the fact finding and analysis of the
Examiner as our own. Appellants provide no specific reasons regarding the
combination of Chee with Bevier and Tower. Since we have found that
argument unpersuasive for the reasons given above, we affirm this rejection.

E. 35 U.S.C. § 103(a) over Bevier, Tower, and Chee
Appellants contend that the
metallic braid of Chee stiffens the balloon catheter.
Specifically, Chee discusses kink resistance at the passages
noted by the Examiner in the rejection of record. The Examiner
provides no evidence and no reason why the designer would
expect that the metallic braid of Chee could successfully
function to assist in maneuvering or steering the system

(App. Br. 23).
The Examiner finds that “Chee states that the metal braiding extends
from the distal to the proximal end of the catheter and provides tensile
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strength (column 3, lines 20-20; column 4, lines 1-5). Therefore, the metal
braiding is of sufficient length and strength to assist in maneuvering and
steering the system from the proximal end” (Ans. 15).
We find that the Examiner has the better position. Chee teaches that
the “braided shaft located in the proximal section allows the physician to
push with the confidence that the catheter will follow the chosen path
without kinking at any point” (Chee, col. 9, ll. 49-51). The ordinary artisan
would have recognized that this is an express teaching by Chee that the braid
permits improved maneuvering of the catheter (see e.g., Ans. 15).

SUMMARY
In summary, we affirm the rejection of claims 88-91 under 35 U.S.C.
§ 112, first paragraph as failing to comply with the written description
requirement.
We affirm the rejection of claim 46 under 35 U.S.C. § 103(a) as
obvious over Bevier and Tower. Pursuant to 37 C.F.R. § 41.37(c)(1), we
also affirm the rejection of claims 67 and 87-91, as these claims were not
argued separately.
We affirm the rejection of claim 49 under 35 U.S.C. § 103(a) as
obvious over Bevier, Tower, and Wijay.
We affirm the rejection of claims 47, 48, 50-53, 68-73, and 86 under
35 U.S.C. § 103(a) as obvious over Bevier, Tower, and Chee.
We affirm the rejection of claims 54, 55, and 92 under 35 U.S.C. §
103(a) as obvious over Bevier, Tower, and Chee.
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No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

cdc