Ex Parte Bales et al

Board of Patent Appeals and Interferences

Jul 20, 2012

11216293 (B.P.A.I. Jul. 20, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte THOMAS O. BALES, CHARLES R. SLATER,
and SCOTT L. JAHRMARKT
__________

Appeal 2011-004599
Application 11/216,293
Technology Center 3700
__________

Before DONALD E. ADAMS, DEMETRA J. MILLS, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a stent.
The Examiner rejected the claims as obvious. We have jurisdiction under 35
U.S.C. § 6(b). We affirm-in-part.

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Statement of the Case
Background
“The invention lies in the field of vascular stents. In particular, the
invention is in the field of helical stents for peripheral arteries, the biliary
tree, and other body lumens” (Spec. 1 ¶ 0003).
The Claims
Claims 1-35 are on appeal. Claim 1 is representative and reads as
follows:
1. A stent, comprising:
a stent body having:
a circumference;
struts disposed helically about said
circumference in turns, at least two of
said struts having respective strut ends; and
at least two paddle-shaped markers extending
away from a respective one of said strut
ends, said markers having respective marker
extreme ends and different overall
longitudinal lengths substantially aligning
said marker extreme ends approximately
along a single circumference of said stent
body.

The issues

A. The Examiner rejected claims 1-3, 6, 7, 12-14, 24-28, and 30-35 under
35 U.S.C. § 103(a) as obvious over Martin
1
and Davila
2
(Ans. 3-5).
B. The Examiner rejected claims 8-11 under 35 U.S.C. § 103(a) as

1
Martin et al., US 6,042,605, issued Mar. 28, 2000.
2
Davila et al., US 6,863,685 B2, issued Mar. 8, 2005.
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obvious over Martin, Davila, and Kveen
3
(Ans. 6).
C. The Examiner rejected claims 4, 5, and 15-23 under 35 U.S.C. §
103(a) as obvious over Martin, Davila, and Mitchell
4
(Ans. 6-7).
D. The Examiner rejected claim 29 under 35 U.S.C. § 103(a) as obvious
over Martin, Davila, and Trapp
5
(Ans. 8).
A. 35 U.S.C. § 103(a) over Martin and Davila
The Examiner finds that “Martin discloses a stent (Fig. 13a) having
struts disposed in a single helix about the circumference of the stent” (Ans.
3). The Examiner finds that “Martin does disclose the use of fluoroscopy to
visualize the end of the graft, but does not further disclose how this would be
achieved (C17: L53). However, Davilla discloses the use of radiopaque
markers (800, 804) at the ends of a stent to ensure precise placement and
post-procedural visualization in a vessel” (Ans. 3-4).
The Examiner finds it obvious to “incorporate the radiopaque markers
onto the strut ends of the stent of Martin in order to achieve the advantages
of better placement and visualization taught by Davilla” (Ans. 4). The
Examiner finds that the “radiopaque markers taught by Davilla are
manufactured directly onto the peaks of the stent, the teaching of which
would be applied to the Martin device” (Ans. 4-5).
Appellants contend that a “person of ordinary skill in the art at the
time of the invention would attach a marker to the graft material of the stent
as opposed to the stent framework as proposed by the Examiner” (App. Br.

3
Kveen et al., US 6,042,597, issued Mar. 28, 2000.
4
Mitchell et al., US 2003/0040754 A1, published Feb. 27, 2003.
5
Trapp, R., US 5,861, 027, issued Jan. 19, 1999.
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8). Appellants contend that “[a]ttaching a marker to the stent structure is
difficult and compromises the stent structure in the assembly area. Markers
are instead more easily attached directly to the graft by various methods”
(App. Br. 8). Appellants contend that the “even if one of ordinary skill in
the art looked to Davila for the suggestion of a marker, it would not lead to
the attachment of the maker to the stent framework of Martin” (App. Br. 8).
Appellants contend that the “method described in Davila to attach the
markers to the stent framework by direct machining is inapplicable to the
stent of Martin formed by a helical winding of a wire. Thus, the combination
is not enabled to permit a person of ordinary skill in the art to carry out the
claimed invention” (App. Br. 10). Appellants contend that “[l]aser cutting a
tube into the unconnected helical design of Martin was not known at the
time of Martin, and is a difficult feat, even today” (App. Br. 11).
Appellants contend that “the only possible option to connect the
helical wire of Martin to the marker of Davila is by welding. However,
welding presents its own problems for the proposed modification” (App. Br.
10). Appellants contend that “joining nitinol to a dissimilar material, for
example a marker, is difficult. . . . Welding provides difficulties in
„formation of brittle intermetallic compounds which strongly limit the
mechanical strength of the joints.‟ (T. Haas, 1999, p. 5.)” (App. Br. 8).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner‟s conclusion that Martin and Davila renders the stent
of claim 1 obvious?

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Findings of Fact
1. Figure 13A of Martin is reproduced below:

“FIG. 13A diagrammatically shows a further stent-member of the present
invention with flared ends (the coupling tape drawn back to more clearly
show the helically wound undulating stent configuration)” (Martin, col. 4, ll.
60-63).
2. Martin teaches that the “stent-graft deployment is initiated
slowly, distal to proximal („downstream to upstream‟) . . . while watching
the proximal end location on fluoroscopy” (Martin, col. 17, ll. 51-53).
3. Davila teaches:
A stent or other intraluminal medical device having markers
formed from housings integral with the stent and marker
inserts having a higher radiopacity than the stent provides
for more precise placement and post-procedural
visualization in a vessel, by increasing the radiopacity of the
stent under X-ray fluoroscopy. The housings are formed
integral to the stent and the marker inserts are made from a
material close in the galvanic series to the stent material and
sized to substantially minimize the effect of galvanic
corrosion.

(Davila, abstract).
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4. Figure 7 of Davila is reproduced below:

“FIG. 7 is a perspective view of the stent . . . having a plurality of markers
attached to the ends thereof” (Davila, col. 6, ll. 3-4).
5. Davila teaches that “Nitinol . . . can withstand extremely large
amounts of elastic strain deformation, so the above features are well suited
to stents made from this alloy” (Davila, col. 9, ll. 30-32).
6. Davila teaches that “[p]referably, stents are laser cut from small
diameter tubing” (Davila, col. 9, l. 40).
7. Davila teaches that in “manufacturing the Nitinol stent, the
material is first in the form of a tube. Nitinol tubing is commercially
available . . . The tubular member is then loaded into a machine which will
cut the predetermined pattern of the stent into the tube . . . Machines for
cutting patterns in tubular devices to make stents or the like are well known”
(Davila, col. 10, ll. 41-48).
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8. Davila teaches that the “conical tapering in the marker housing
802 is beneficial in providing an interference fit between the marker insert
804 and the marker housing 802 to prevent the marker insert 804 from being
dislodged once the stent 100 is deployed” (Davila, col. 11, ll. 28-32).
9. Davila teaches that the “marker inserts 804 may be made from
any suitable material having a radiopacity higher than the superelastic
material forming the stent or other medical device. For example, the marker
insert 804 may be formed from niobium, tungsten, gold, platinum or
tantalum” (Davila, col. 11, ll. 35-39).
Principles of Law
“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.
Analysis
Claim 1
Martin teaches a stent with a stent body with struts disposed
helically about the circumference (FF 1) which is subject to fluoroscopic
detection during deployment (FF 2).
Davila teaches stents with integral housings that contain marker
inserts with higher radioopacity for “more precise placement and post-
procedural visualization in a vessel, by increasing the radiopacity of the stent
under X-ray fluoroscopy” (Davila, abstract; FF 3). Davila teaches that
“[p]referably, stents are laser cut from small diameter tubing” (Davila, col.
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9, l. 40; FF 5). Davila teaches that in “manufacturing the Nitinol stent, the
material is first in the form of a tube. Nitinol tubing is commercially
available . . . The tubular member is then loaded into a machine which will
cut the predetermined pattern of the stent into the tube . . . Machines for
cutting patterns in tubular devices to make stents or the like are well known”
(Davila, col. 10, ll. 41-48; FF 7).
Applying the KSR standard of obviousness to the findings of fact, we
conclude that the person of ordinary skill would have predictably modified
the stent of Martin with the stent housings of Davila to increase radiopacity
for improved placement and visualization (FF 3). We further agree with the
Examiner that it would have been obvious that the “radiopaque markers
taught by Davilla are manufactured directly onto the peaks of the stent, the
teaching of which would be applied to the Martin device” (Ans. 4-5). That
is, Davila repeatedly teaches that the entire stent, including the housings,
may be laser cut from commercially available nitinol tubes using
commercially available machines (FF 7). Such a combination is merely a
“predictable use of prior art elements according to their established
functions.” KSR, 550 U.S. at 417.
Appellants contend that a “person of ordinary skill in the art at the
time of the invention would attach a marker to the graft material of the stent
as opposed to the stent framework as proposed by the Examiner” (App. Br.
8). Appellants contend that “[a]ttaching a marker to the stent structure is
difficult and compromises the stent structure in the assembly area. Markers
are instead more easily attached directly to the graft by various methods”
(App. Br. 8). Appellants contend that the “even if one of ordinary skill in
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the art looked to Davila for the suggestion of a marker, it would not lead to
the attachment of the maker to the stent framework of Martin” (App. Br. 8).
We are not persuaded. Davila expressly teaches that entire stents,
with at least as complicated shapes as those shown by Martin, can be laser
cut from nitinol tubes using commercially available materials and machines
(FF 7). Davila expressly teaches that the preferred formation of the housings
is by forming them integral to the stent (FF 3), which would not require any
attachment whatsoever.
Appellants contend that the “method described in Davila to attach the
markers to the stent framework by direct machining is inapplicable to the
stent of Martin formed by a helical winding of a wire. Thus, the combination
is not enabled to permit a person of ordinary skill in the art to carry out the
claimed invention” (App. Br. 10).
We are not persuaded. The Examiner is not suggesting that the stent
of Martin is formed by helical winding, but rather that the “radiopaque
markers taught by Davilla are manufactured directly onto the peaks of the
stent, the teaching of which would be applied to the Martin device” (Ans. 4-
5). The Examiner reasonably relies upon Martin solely for the shape of the
stent, but relies upon Davila for the method of manufacture of the stent (see
Ans. 4-5). To the extent that Appellants contend that the ordinary artisan
would have been unable to use commercially available machinery as taught
by Davila to laser cut the stent shape of Martin, Appellants have provided no
evidence that the stent of Martin could not be cut, while the more
complicated shapes shown in Davila could be cut. See In re Pearson, 494
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F.2d 1399, 1405 (CCPA 1974) (“Attorney‟s argument in a brief cannot take
the place of evidence.”)
Appellants contend that “[l]aser cutting a tube into the unconnected
helical design of Martin was not known at the time of Martin, and is a
difficult feat, even today” (App. Br. 11).
We are not persuaded. Davila teaches “manufacturing the Nitinol
stent, the material is first in the form of a tube. Nitinol tubing is
commercially available . . . The tubular member is then loaded into a
machine which will cut the predetermined pattern of the stent into the tube . .
. Machines for cutting patterns in tubular devices to make stents or the like
are well known” (Davila, col. 10, ll. 41-48). Appellants have provided no
rebuttal evidence, and the state of the art at the time of Martin in 1997, does
not limit Davila‟s state of the art in 2001 or the proper analysis, which looks
to what would have been “obvious at the time the invention was made” (35
U.S.C. § 103(a)) as of the provisional filing date of September 1, 2004, the
earliest demonstrated point of constructive reduction to practice of the
invention.
Appellants contend that “the only possible option to connect the
helical wire of Martin to the marker of Davila is by welding. However,
welding presents its own problems for the proposed modification” (App. Br.
10). Appellants contend that “joining nitinol to a dissimilar material, for
example a marker, is difficult. . . . Welding provides difficulties in
„formation of brittle intermetallic compounds which strongly limit the
mechanical strength of the joints.‟ (T. Haas, 1999, p. 5.)” (App. Br. 8).
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We do not agree. We have considered the Zipse Declaration
6
and the
Haas Declaration
7
, but as we have discussed above, welding is not the only
possible option for incorporating the housings of Davila into the wire of
Martin. The entire stent of Martin, including housings as taught by Davila,
could be formed by laser cutting a nitinol tube using routine techniques and
commercially available machinery as taught by Davila (FF 7).
Claim 6
Appellants contend that “asserted combination of Martin/Davila does
not show or describe a marker with flat surfaces” (App. Br. 18) Appellants
contend that the “asserted marker of Davila is formed from a cut tube, and is
in the shape of an ellipse . . . Thus, Davila does not disclose any flat surfaces
for the asserted marker” (App. Br. 18).
The Examiner finds “that „flat‟ does not necessarily require straight or
non-arched surfaces, but rather can be interpreted as smooth or without
texture” (Ans. 11).
We find that the Examiner has the better position since the markers
shown in Figure 7 are shown to have a flat surface as shown in an expanded
view of a portion of figure 7 (FF 4), reproduced below:

6
Declaration of Achim Zipse, filed Aug. 3, 2010.
7
Declaration of Thomas Haas, filed Aug. 3, 2010.
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Claim 12
Appellants contend that “in order to weld a radiopaque marker to a
stent, one must choose carefully not to make the weld at a position on the
stent that is subject to bending conditions” (App. Br. 18). Appellants
“submits that the Martin disclosure teaches away from a combination of
its stent with the Davila marker pursuant to the knowledge of one of
ordinary skill in the art of stent manufacturing” (App. Br. 19).
The Examiner finds that one “of skill is readily aware that many
characteristics must be considered in designing stents and compromising
one feature for another is a constant conflict” (Ans. 12).
We find that the Examiner has the better position. We are not
persuaded by Appellants‟ position since we have already found that the
housings may be formed by laser cutting the nitinol tube, rather than
welding (FF 7).
Conclusion of Law
The evidence of record supports the Examiner‟s conclusion that
Martin and Davila renders the stent of claim 1 obvious.
B. 35 U.S.C. § 103(a) over Martin, Davila, and Kveen
The Examiner finds that “Martin modified by Davilla does not
disclose multiple helices” (Ans. 6). The Examiner finds that “Kveen
discloses a helical stent with connecting elements (14) that create closed
flexible cells to yield a flexible, conformable stent that expands
uniformly and provides good radial strength, scaffolding and fatigue
characteristics when expanded” (Ans. 6). The Examiner finds that the
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“connecting elements turn the single helix stent into a multiple helix
stent” (Ans. 6). The Examiner finds it obvious “to incorporate
connecting elements into the stent of Martin modified by Davilla to
achieve the same predictable results taught by Kveen” (Ans. 6).
Appellants contend that the “connecting elements 14 of Kveen do
not supply the missing limitation” (App. Br. 19). Appellants contend that
the “asserted second helical portion of Kveen, interconnecting the
primary asserted helical portion of Martin would prevent the respective
apex portions from moving within a corresponding undulation base
portion of an adjacent turn” (App. Br. 20). Appellants contend that “even
assuming arguendo the connecting elements can be considered multiple
helices, as claimed, Martin teaches away from such a connecting
element” (App. Br. 20).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner‟s conclusion that Martin, Davila, and Kveen render
the stent of claim 8 obvious?
Findings of Fact
10. Figure 2 of Kveen is reproduced below:

Figure 2 displays a view of a stent (see Kveen, col. 2, l. 36).
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11. Kveen teaches that a “double parallel helix or multiple
parallel helices may also be used” (Kveen, col. 2, ll. 26-27).
12. Kveen teaches “a helically wound serpentine or undulating
structure including curved connecting elements, i.e., curvilinear, which
produces closed flexible cells in the expanded form. In combination the
flexible cells yield a flexible, conformable stent which expands uniformly
and provides good radial strength, scaffolding and fatigue characteristics
when expanded” (Kveen, col. 1, ll. 61-67).
13. Martin teaches that “a linking member 20 may be provided
to maintain the phased relationship of the undulations during
compression and deployment, and during bending of the stent member”
(Martin, col. 5, ll. 55-58).
Principles of Law
A reference may be said to teach away when a person of
ordinary skill, upon reading the reference, would be
discouraged from following the path set out in the reference,
or would be led in a direction divergent from the path that
was taken by the applicant. The degree of teaching away
will of course depend on the particular facts; in general, a
reference will teach away if it suggests that the line of
development flowing from the reference's disclosure is
unlikely to be productive of the result sought by the
applicant.

In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994).
Analysis
Claim 8
Kveen teaches advantages in modifying undulating helical stents
with curved connector elements (FF 12). Martin expressly teaches that a
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linking member, similar to the connector elements of Kveen, may be
included to maintain the phased relationship of the undulations of the
Martin stent (FF 13).
Appellants contend that “even assuming arguendo the connecting
elements can be considered multiple helices, as claimed, Martin teaches
away from such a connecting element” (App. Br. 20).
We are not persuaded since this argument does not meet the
requirements for demonstrating a teaching away. Appellants do not point
to any teaching in Martin which would discourage the use of connecting
elements, and in fact, Martin expressly teaches that connecting elements
are desirable (FF 13). Kveen provides clear specific advantages for the
inclusion of curved connector elements including the ability to form “a
flexible, conformable stent which expands uniformly and provides good
radial strength, scaffolding and fatigue characteristics when expanded”
(Kveen, col. 1, ll. 64-67; FF 12).
Claim 9
Appellants contend that “the asserted connecting elements (14)
do not start and end at the at the proximal end and distal end of the stent”
(App. Br. 20). Appellants contend that “the primary helix creates the
proximal and distal ends of the stent, and thus, the multiple helices are
spaced from the ends by at least one turn of the primary helix” (App. Br.
21).
The Examiner did not specifically address the limitation of claim 9
in either the original rejection or in the Examiner‟s Answer. We
therefore are constrained to reverse the rejection of claim 9, since there is
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no evidence teaching the location of the start of the helices in Kveen or
Martin.
Claim 11
Appellants contend that the “combination of Martin/Davila in view
of K veen fails to show and describe „each of said helices has a
continuous repetition of said s-shaped struts throughout a length of said
helices‟” (App. Br. 21).
We are not persuaded. Figure 2 of Kveen reasonably shows a
continuous repetition of s-shaped struts throughout the length of the
helix.
Conclusion of Law
The evidence of record supports the Examiner‟s conclusion that
Martin, Davila, and Kveen render the stent of claims 8, 10 and 11
obvious.
The evidence of record does not support the Examiner‟s
conclusion that Martin, Davila, and Kveen render the stent of claim 9
obvious.
C. 35 U.S.C. § 103(a) over Martin, Davila, and Mitchell
The Examiner finds that “Martin modified by Davilla does not
disclose the use of ultrasound or magnetic resonance imaging markers”
(Ans. 6). The Examiner finds that “Mitchell discloses that the stents may
be marked or tagged with radiopaque or non-ferromagnetic materials to
facilitate in vivo visualization via x-ray, magnetic resonance imaging or
ultrasound” (Ans. 6). The Examiner finds it obvious to “substitute one
type of marker for another since Mitchell teaches that radiopaque,
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ultrasonic and MRI markers are equivalent structures known in the art”
(Ans. 6).
Appellants contend that “none of the cited references supply the
missing limitation of multiple or a combination of imaging
characteristics. Instead, if an imaging characteristic or marker is shown or
described, it is in the alternative” (App. Br. 23). Appellants submit “that
the addition of a combination of multiple imaging markers is not a mere
design choice” (App. Br. 23).
Appellants state that in “the Answer to this Brief, Appellant
respectfully requests the Examiner to supply documentary evidence of
these limitations within the cited art, and/or a line of reasoning to support
a prima facie case that the limitations are in fact obvious over the cited
combination” (App. Br. 23).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner‟s conclusion that Martin, Davila, and Mitchell render
combinations of imaging markers obvious as required by claims 4 and 23?
Findings of Fact
14. Mitchell teaches that “the stents may be marked or tagged
with radiopaque or non-ferromagnetic materials to facilitate in vivo
visualization via x-ray, magnetic resonance imaging or ultrasound”
(Mitchell 5 ¶ 0061).
Principles of Law
The Supreme Court has stated “[c]ommon sense teaches, however,
that familiar items may have obvious uses beyond their primary
purposes, and in many cases a person of ordinary skill will be able to fit
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the teachings of multiple patents together like pieces of a puzzle.” KSR,
550 U.S. at 420.
Analysis
Appellants do not dispute that the ordinary artisan, familiar with
the prior art, would have known about “using various separate markers to
be detected by separate imaging devices” (Reply Br. 15). Appellants
contend, however, that “none of the cited references supply the missing
limitation of multiple or a combination of imaging characteristics.
Instead, if an imaging characteristic or marker is shown or described, it is
in the alternative” (App. Br. 23).
We are not persuaded. While Martin and Davila may be limited to
teaching X-ray fluoroscopy for stent visualization (FF 2, 4), Mitchell
clearly teaches that a stent may be visualized using magnetic resonance
imaging or ultrasound as well as radiopaque markers, and that other
materials for use in these detection modalities may be used as markers
(FF 14). Mitchell expressly teaches tagging with different materials for
detection using different visualization techniques (FF 14). We agree with
the Examiner that the ordinary artisan, with ordinary skill, ordinary
creativity, and ordinary common sense, would have had reason to label a
single stent with different types of markers when different types of
visualization techniques may be used to identify the location of the stent.
Conclusion of Law
The evidence of record supports the Examiner‟s conclusion that
Martin, Davila, and Mitchell render combinations of imaging markers
obvious as required by claims 4 and 23
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D. 35 U.S.C. § 103(a) over Martin, Davila, and Trapp
Appellants do not separately argue the claims in this obviousness
rejection. Having affirmed the obviousness rejection of Claim 1 over Martin
and Davila, we also find the further combination of with Trapp renders claim
29 obvious for the reasons given by the Examiner (see Ans. 8).
SUMMARY
In summary, we affirm the rejection of claims 1, 6, and 12 under 35
U.S.C. § 103(a) as obvious over Martin and Davila. Pursuant to 37 C.F.R. §
41.37(c)(1), we also affirm the rejection of claims 2, 3, 7, 13, 14, 24-28, and
30-35 as these claims were not argued separately.
We affirm the rejection of claims 8, 10 and 11 under 35 U.S.C. §
103(a) as obvious over Martin, Davila, and Kveen.
We reverse the rejection of claim 9 under 35 U.S.C. § 103(a) as
obvious over Martin, Davila, and Kveen.
We affirm the rejection of claims 4, 5, and 15-23 under 35 U.S.C. §
103(a) as obvious over Martin, Davila, and Mitchell.
We affirm the rejection of claim 29 under 35 U.S.C. § 103(a) as
obvious over Martin, Davila, and Trapp.
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-IN-PART

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