Ex Parte Jennings et al

Patent Trial and Appeal Board

May 8, 2014

12233078 (P.T.A.B. May. 8, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte ADAM JENNINGS, TED LAYMAN,
TRACEE EIDENSCHINK, MATT HEIDNER, and CLAY NORTHROP1
__________

Appeal 2012-001785
Application 12/233,078
Technology Center 3700
__________

Before TONI R. SCHEINER, LORA M. GREEN, and MELANIE L.
McCOLLUM, Administrative Patent Judges.

McCOLLUM, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a medical
device. The Examiner has rejected the claims as anticipated or obvious. We
have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part.
STATEMENT OF THE CASE
Claims 1, 3, 4, 6-11, and 15-17 are pending and on appeal (App.
Br. 4). Claims 1, 3, 4, 9, and 15 are illustrative and read as follows:

1 Appellants identify the real party in interest as Boston Scientific Scimed,
Inc. (App. Br. 4.)
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1. A medical device comprising:
a hypotube comprising a region having a plurality of slots;
wherein the medical device is configured to exhibit preferential
bending in a single direction within the region having a plurality of slots;
and
an additional element disposed on a portion of an exterior surface of
the hypotube that causes the medical device to exhibit preferential bending
in a single direction;
wherein the portion comprises about one half of the exterior surface or
less.
3. The medical device of claim 1, wherein the additional element is
secured to a side of the hypotube, and permits at least some of the slots on
said side to open but not to close.
4. The medical device of claim 1, wherein the additional element is
secured to a side of the hypotube, and permits at least some of the slots on
said side to close but not to open.
9. A medical device comprising:
a hypotube having a first exterior side surface and an opposing second
exterior side surface;
a first plurality of slots disposed within the first exterior side surface;
a second plurality of slots disposed within the second exterior side
surface; and
a restricting element disposed only along the first exterior side
surface.
15. A medical device comprising:
an elongate spiral cut member defining an exterior surface; and
a plurality of tethers axially disposed about the exterior surface.
Claims 1 and 6-8 stand rejected under 35 U.S.C. § 102(b) as
anticipated by Gaber (US 2004/0059257 A1, Mar. 25, 2004) (Ans. 4).
Claims 3 and 4 stand rejected under 35 U.S.C. § 103(a) as obvious
over Gaber in view of McDaniel et al. (US 7,276,062 B2, Oct. 2, 2007)
(Ans. 5).
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Claims 9-11 stand rejected under 35 U.S.C. § 103(a) as obvious over
Weber et al. (US 2007/0112331 A1, May 17, 2007) in view of Krogh et al.
(US 2009/0082723 A1, Mar. 26, 2009) (Ans. 6).
Claims 15-17 stand rejected under 35 U.S.C. § 103(a) as obvious over
Weber in view of McDaniel (Ans. 7).
I
The Examiner finds that Gaber anticipates claim 1 (Ans. 4-5). In
particular, the Examiner finds that Gaber discloses a medical device
comprising “a hypotube (12) comprising a region having a plurality of
slots (14)” and “an additional element (16) disposed on a portion of an
exterior surface of the hypotube that causes the medical device to exhibit
preferential bending in a single direction” (id.).
Findings of Fact
1. As depicted in Figure 1, Gaber discloses “a tube [12] formed
with a plurality of radial slits [14] spaced axially from each other” (Gaber,
¶¶ [0009] & [0030]).
2. Gaber also discloses that, “[w]hen a compressive force is
applied to the slits, such as by pulling with a pull wire [16] attached to a
distal portion of the tube, the tube buckles and bends towards the side of the
slits” (id. at ¶¶ [0009] & [0034]).
3. In addition, Gaber discloses that “[p]ull wire 16 extends
through tube 12 and exits through a proximal end of tube 12” (id. at
¶ [0034]).
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Analysis
Appellants argue that “[n]owhere does Gaber appear to disclose: ‘an
additional element disposed on a portion of an exterior surface of the
hypotube that causes the medical device to exhibit preferential bending in a
single direction’, as recited in claim 1” (App. Br. 7). We conclude that
Appellants have the better position.
The Examiner relies on pull wire 16 as the additional element
(Ans. 5). However, the Examiner has not shown that pull wire 16 is
disposed on an exterior surface of tube 12.
We agree with the Examiner that the limitation “disposed on” does
not require attachment of the additional element to an exterior surface of the
tube (id. at 10). However, we do not agree with the Examiner that Gaber’s
figures demonstrate that pull wire 16 is “arranged” on an exterior surface of
tube 12 (id.). Instead, “[p]ull wire 16 extends through tube 12 and exits
through a proximal end of tube 12” (Finding of Fact (FF) 3).
Conclusion
The Examiner has not set forth a prima facie case that Gaber teaches a
medical device according to claim 1. We therefore reverse the anticipation
rejection of claim 1 and of claims 6-8, which depend from claim 1.
II
In rejecting claims 3 and 4, the Examiner relies on Gaber for
disclosing that “the additional element (16) is secured to a side of the
hypotube” (Ans. 5). However, the Examiner notes “that Gaber does not
specifically teach the additional element permits some of the slots to open
but not to close, and some of the slots to close but not open” (id.).
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The Examiner relies on McDaniel for teaching that “the additional
element (40, 60) is secured to a side of the hypotube . . . and permits at least
some of the slots (44b) on the side to open but not to close . . . and some of
the slots on the side to close but not to open (44a . . . )” (id.). The Examiner
concludes that it would have been obvious “to modify the device of Gaber to
include some slots that open but don’t close and some slots that close but
don’t open, as disclosed in McDaniel et al., so as to control the direction and
extend bending of the shaft” (id. at 5-6).
Findings of Fact
4. McDaniel discloses a steerable catheter comprising “an
elongated catheter shaft 12 having proximal and distal ends, an intermediate
shaft 14 at the distal end of the catheter shaft over which [a] hinge is
mounted” (McDaniel, col. 2, ll. 46-51).
5. McDaniel also discloses that hinge 40 includes slots 44 and
that, “[a]s the hinge 40 bends, the compressible slots 44a are compressed so
that the inwardly-angled openings 50 close, and the expandible slots 44b
expand so that the elongated slots 54 of insignificant thickness open, as best
depicted in FIG. 9” (id. at col. 4, ll. 29-30, & col. 5, ll. 42-46).
6. In addition, McDaniel discloses “including a flexible hinge
cover 60 over the hinge” and that “hinge cover 60 . . . should not limit the
ability of the hinge 40 to bend” (id. at col. 5, ll. 56-62).
Analysis
Appellants argue that “McDaniel does not overcome the deficiencies
of Garber [sic] with regard to an additional element disposed on a portion of
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an exterior surface of a hypotube as applied to independent claim 1” (App.
Br. 12). We conclude that Appellants have the better position.
We do not disagree with the Examiner’s conclusion that it would have
been obvious “to modify the device of Gaber to include some slots that open
but don’t close and some slots that close but don’t open, as disclosed in
McDaniel” (Ans. 5-6). However, we agree with Appellants that the
Examiner does not adequately explain how this combination would
overcome the above-mentioned deficiency in Gaber.
We note the Examiner’s position that hinge cover 60 can be
considered the claimed additional element (id. at 15). However, the
Examiner has not shown that hinge cover 60 “causes the medical device to
exhibit preferential bending in a single direction,” as required by claim 1.
Instead, McDaniel discloses that “hinge cover 60 . . . should not limit the
ability of the hinge 40 to bend” (FF 6).
Conclusion
The Examiner has not set forth a prima facie case that Gaber and
McDaniel suggest a medical device according to claims 3 and 4. We
therefore reverse the obviousness rejection of claims 3 and 4.
III
In rejecting claim 9, the Examiner relies on Weber for disclosing a
medical device comprising “a hypotube (24) having a first side surface and
an opposing second side surface,” “a first plurality of slots (36, 40) disposed
within the first side surface,” and “a second plurality of slots (36, 42)
disposed within the second side surface” (Ans. 6). The Examiner also finds
that Weber “discloses a restricting element (46, 60 . . . ), but . . . note[s] that
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Weber . . . does not specifically teach the restricting element disposed only
along the first exterior side surface” (id.).
The Examiner relies on Krogh for teaching “a restricting element (22,
23) disposed only along the first exterior side surface” (id.). The Examiner
concludes that it would have been obvious “to modify the device of Weber
et al. to include a restricting element disposed only along the first exterior
side surface, as disclosed in Krogh et al., so as to provide a device having a
variable and controllable stiffness” (id.). In addition, the Examiner
concludes that “[o]ne of ordinary skill in the art would be motivated to
combine the teachings of Weber et al. and Krogh et al. because both
explicitly teach restricting elements that selectively and preferentially
control the flexibility and bending of a tubular medical device” (id. at 20).
Findings of Fact
7. Weber relates “to medical devices having elongate shafts that
provide adjustability in flexibility, stiffness or compressive strength”
(Weber, ¶ [0001]).
8. Weber Figure 2 is reproduced below:

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Weber “FIG. 2 illustrates a micromachined hypotube 24 having a . . .
number of slots 36 . . . disposed along the length of the micromachined
hypotube 24” (id. at ¶ [0050]).
9. Weber discloses:
It can be seen that individual slots 36 may be considered as
being in pairs 38, with a pair 38 including a first slot 40 and a
second slot 42. In some embodiments, as illustrated, the first
slot 40 can have a first radial position on the micromachined
hypotube 24 while the second slot 42 occupies a second radial
position that is rotated from the first radial position. In some
embodiments, as illustrated, the second slot 42 can be rotated
about 90 degrees from the first slot 40. In other instances, the
radial rotation can vary, especially if, for example, first slot 40
and second slot 42 are either longer or shorter than the
illustrated length.
(Id. at ¶ [0053].)
10. In one embodiment, Weber discloses “a medical device that
includes a hypotube and an electroactive polymer sleeve that is disposed
over the hypotube,” wherein the “hypotube includes a number of slots
disposed within the hypotube” (id. at ¶ [0006]).
11. In particular, Weber discloses that “the sleeve 46 may be
formed of an electroactive polymer which can, when subjected to a potential
difference, accommodate ions which may cause the electroactive polymer to
swell” (id. at ¶ [0058]; see also Fig. 5, which depicts “a sleeve 46 that has
been changed into an activated configuration in which portions 54 of the
sleeve 46 extend at least partially into the slots 36” (id. at ¶ [0059])).
12. In another embodiment, Weber discloses “a medical device that
includes a hypotube that has a slot formed within the hypotube, the slot
including a first wall and an opposing second wall,” wherein an
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“electroactive polymer is disposed on at least one of the first wall and the
opposing second wall” (id. at ¶ [0009]).
13. In particular, Weber discloses:
It will be recognized that activating the electroactive
polymer 60 within certain slots 36 while not activating the
electroactive polymer 60 within other slots 36 may be useful in
causing the hypotube 24 to bend. For example, activating the
electroactive polymer 60 only within the slots 36 along a first
side of the hypotube 24 can cause the hypotube 24 to bend in a
direction opposite that of the first side of the hypotube 24.
(Id. at ¶ [0095].)
14. Krogh discloses:
an elongate device for introduction into a body lumen,
comprising a body extending in a longitudinal direction, and
having at least two skeletal members, which are substantially
aligned in the longitudinal direction, and at least one
electroactive polymer material, which changes volume upon
electrical activation, arranged to control a distance between two
longitudinally spaced-apart portions of said skeletal members.
(Krogh, ¶ [0048].)
15. Krogh also discloses that “the electroactive polymer material is
asymmetrically arranged about a central axis of the device, such that the
body is arranged to bend transversely of the longitudinal direction upon
activation of the electroactive polymer material” (id.).
16. In addition, Krogh discloses that “the electroactive polymer
[EAP] material is provided on an inwardly and/or outwardly facing surface
of [a] tubular body” (id. at ¶ [0062]).
17. In particular, Krogh discloses “adding bulk EAP material 22 to
a portion of [a] coil 20, linking each turn on the coil together,” and that,
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“[b]y having the EAP material distributed asymmetrically or
inhomogeneously, a volume expansion of the EAP will result in a bending
motion, towards the non-EAP covered side, as is illustrated in FIGS. 2a and
2b” (id. at ¶ [0119]).
18. Krogh Figure 2e is reproduced below:

“In [Krogh] FIG. 2e, the EAP material 22 is provided substantially on an
outside of the coil 20” (id. at ¶ [0129]).
Analysis
Weber discloses a hypotube 24 having a number of slots 36 disposed
along its length (FF 8). While we agree with Appellants that slots 40 and 42
are not on opposing exterior sides (App. Br. 14), we agree with the
Examiner that Weber discloses a hypotube having a first plurality of slots
disposed within a first exterior side surface and a second plurality of slots
disposed within an opposing exterior side surface, specifically the slots at
the top and the bottom of the hypotube depicted in Weber Figure 2 (FF 8-9).
In addition, Weber discloses including an electroactive polymer on the
hypotube and that “activating the electroactive polymer 60 only within the
slots 36 along a first side of the hypotube 24 can cause the hypotube 24 to
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bend in a direction opposite that of the first side of the hypotube 24” (FF 10-
13).
Krogh discloses an elongate device comprising at least one
electroactive polymer material, wherein “the electroactive polymer material
is asymmetrically arranged about a central axis of the device, such that the
body is arranged to bend transversely of the longitudinal direction upon
activation of the electroactive polymer material” (FF 14-15; see also FF 17).
Krogh also discloses that “the electroactive polymer material is provided on
an . . . outwardly facing surface of [a] tubular body” (FF 16; see also FF 18).
Based on the teachings in Krogh, we agree with the Examiner that it would
have been obvious to asymmetrically arrange the electroactive polymer
material only along a first exterior side surface of Weber’s hypotube in order
to cause the hypotube to bend in a particular direction.
Appellants argue, however, “that any portion of a restricting element
of either Weber or Krogh which extends inwardly through the cylindrical
surface defining the exterior surface is not disposed only along the first
exterior side surface” (App. Br. 17). We are not persuaded.
Krogh discloses that “the electroactive polymer material is provided
on an . . . outwardly facing surface of [a] tubular body” (FF 16). Appellants
have not pointed to in any teaching in Krogh that indicates that, before it is
activated, a portion of the electroactive polymer material must extend into
the spaces between the coils members. However, even if it did, Appellants
have not adequately explained why this would be excluded by the recitation
in claim 9 that the restricting element is “disposed only along the first
exterior side surface.” In fact, claim 10 depends from claim 9 and recites
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that the restricting element comprises a polymeric ribbon melted into at least
some of the first plurality of slots, indicating that this is not excluded.
In addition, Appellants argue:
Krogh cannot disclose a restrictive element disposed only along
a first side surface, an element acknowledged to be missing
[from] Weber, for at least the reasons that there are no
distinguishable first and second side surfaces to the coil of
Krogh and the electroactive polymer of Krogh, like that of
Weber is an electroactive polymer which moves elements of the
respective tubes to bend them rather than restricting their
motion.
(Reply Br. 16.) We are not persuaded.
Claim 9 recites a restricting element. However, claim 9 does not
recite what this element restricts, nor do we find a clear definition of the
term “restricting” in the Specification. The Examiner considers the
electroactive polymer disclosed in both Weber and Krogh to be a restricting
element (Ans. 6). As noted by Appellants, “elements 22 of Krogh [that is,
the electroactive polymer material (FF 17-18)] . . . actively caused the coil to
move” (Reply Br. 15). However, Appellants’ argument does not persuade
us that Krogh’s element 22 does not restrict the device in some other way,
such as from bending towards the electroactive polymer.
With regard to the alleged failure of Krogh to teach “distinguishable
first and second side surfaces” (id. at 16), we note that the question is what
the combination of references suggests. As discussed above, Weber
discloses that “activating the electroactive polymer 60 only within the
slots 36 along a first side of the hypotube 24 can cause the hypotube 24 to
bend in a direction opposite that of the first side of the hypotube 24” (FF 13)
and Krogh discloses that “the electroactive polymer material is
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asymmetrically arranged about a central axis of the device, such that the
body is arranged to bend transversely of the longitudinal direction upon
activation of the electroactive polymer material” (FF 15). We conclude that
the combination of references suggests an electroactive polymer disposed
only along the first exterior side surface.
Appellants also argue that the “Examiner has not articulated a reason
for placing the expanding electroactive polymer of Krogh on the exterior
surface of a tube of Weber where it would not reasonably be expected to
force two elements apart to bend the tube of Weber” (Reply Br. 17). We are
not persuaded.
Krogh discloses that the electroactive polymer material is “arranged to
control a distance between two longitudinally spaced-apart portions of [the]
skeletal members” (FF 14). In particular, Krogh discloses that “the
electroactive polymer material is asymmetrically arranged about a central
axis of the device, such that the body is arranged to bend transversely of the
longitudinal direction upon activation of the electroactive polymer material”
(FF 15; see also FF 17). In addition, Krogh specifically discloses that “the
electroactive polymer material is provided on an . . . outwardly facing
surface of [a] tubular body” (FF 16; see also FF 18). Therefore, Appellants’
argument does not persuade us that the combination would not have been
reasonably expected to force the slots of the first exterior side surface to
open, thereby bending the tube.
Conclusion
The evidence supports the Examiner’s conclusion that Weber and
Krogh suggest the device of claim 9. We therefore affirm the obviousness
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rejection of claim 9. Claims 10 and 11 have not been argued separately and
therefore fall with claim 9. 37 C.F.R. § 41.37(c)(1)(vii).
IV
In rejecting claim 15, the Examiner relies on Weber for disclosing “a
medical device comprising an elongate spiral cut member (12, 24) defining
an exterior surface” (Ans. 7). The Examiner notes that Weber “does not
specifically teach a plurality of tethers axially disposed about the exterior
surface” (id.).
The Examiner relies on McDaniel for teaching “a plurality of
tethers (76) axially disposed about the exterior surface” (id.). The Examiner
concludes that it would have been obvious “to modify the device of Weber
et al. to include a plurality of tethers, as disclosed in McDaniel et al., so as to
enhance the ability to manipulate the tip of the device” (id.).
Findings of Fact
19. The Specification discloses “a medical device that includes an
elongate spiral cut member defining an exterior surface. A plurality of
tethers are axially disposed about the exterior surface.” (Spec. 2: 11-13
(emphasis added).)
20. In particular, Specification
Figures 8-9 provide illustrative but non-limiting examples of
structures . . . that can provide preferential bending to the
catheter 10 (Figure 1). Figure 8 shows a side elevation of an
assembly . . . while Figure 9 provides a cross-section
therethrough. The assembly 128 . . . includes a spiral-cut
tube 130 and several tethers 132 that are secured to an exterior
of the spiral-cut tube 130.
(Id. at 18: 3-7.)
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21. Weber discloses that “one or more of the slots 36 may extend
spirally about the hypotube 24” (Weber, ¶ [0051]).
22. McDaniel discloses that its catheter can “include a mechanism
for deflecting the distal region 22 of the catheter shaft 12. In the depicted
embodiment, a puller wire 76 extends through proximal region 20 of the
catheter shaft 12.” (McDaniel, col. 8, ll. 16-19.)
23. McDaniel also discloses that “two or more puller wires can be
provided to enhance the ability to manipulate the tip section” (id. at col. 9,
ll. 25-26).
Analysis
Appellants argue that “[n]owhere does McDaniel disclose that wire or
wires 76 are disposed about the exterior of catheter 12, as asserted by the
Examiner, but rather McDaniel discloses puller wire(s) 76 disposed in
lumens of inner shaft 14” (App. Br. 18). We conclude that Appellants have
the better position.
The Examiner finds that “the limitation ‘axially disposed about the
exterior surface’ merely requires coaxial alignment and proximity of the
tethers with the exterior surface and in no way requires the tethers be on the
outside or in contact with exterior surface of the elongate spiral cut member”
(Ans. 22). However, giving the limitation its broadest reasonable
interpretation, we agree with Appellants that it should be interpreted to
require that the tethers be disposed around or on all sides of the exterior
surface (App. Br. 19). Thus, we agree with Appellants that the Examiner
has not shown that McDaniel (or Weber) teaches or suggests a plurality of
tethers axially disposed about the exterior surface.
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Conclusion
The Examiner has not set forth a prima facie case that Weber and
McDaniel suggest a medical device according to claim 15. We therefore
reverse the obviousness rejection of claim 15 and of claims 16 and 17, which
depend from claim 15.
SUMMARY
We affirm the obviousness rejection of claims 9-11. However, we
reverse the anticipation rejection of claims 1 and 6-8 and the obviousness
rejections of claims 3, 4, and 15-17.
TIME PERIOD FOR RESPONSE
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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