Ex Parte Crank

Board of Patent Appeals and Interferences

May 14, 2009

10647613 (B.P.A.I. May. 14, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte JUSTIN M. CRANK
__________

Appeal 2009-03881
Application 10/647,613
Technology Center 3700
__________

Decided:2 May 14, 2009
__________

Before RICHARD M. LEBOVITZ, FRANCISCO C. PRATS, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

1 Boston Scientific Scimed, Inc., is the real party in interest (App. Br. 3).
2 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, begins to run from the decided date
shown on this page of the decision. The time period does not run from the
Mail Date (paper delivery) or Notification Date (electronic delivery).

Appeal 2009-0388
Application 10/647,613

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to medical
devices. The Examiner has rejected the claims as obvious. We have
jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part.
STATEMENT OF THE CASE
The claimed invention “pertains to intra-lumenal medical devices,
such as guidewires, catheters or the like, wherein in use, they are inserted
into vascular lumens or other body lumens for treatment and diagnosis”
(Spec. 1). The claimed medical devices include “a coil having a longitudinal
axis and a radial axis orthogonal to the longitudinal axis, formed from a
wire” (id.).
Appellant’s Figure 1, reproduced below, “is a perspective view of an
example coil” (id. at 3):

Figure 1 shows coil 110, “incorporated into an elongate medical
device 100 . . . [which] may include an elongate shaft or core 130. The
elongate shaft or core 130 can have a proximal end 131 and an opposing
distal end 132” (id. at 5). As seen in Figure 1, “[t]he coil 110 may have a
plurality of windings 105 that form a coil length L” (id.).
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As also seen in Figure 1, “[i]n some embodiments, the coil 110 can be
wrapped [around the core] in a helical fashion by conventional winding
techniques” (id. at 7). Further, “[t]he coil 110 has a longitudinal axis x, and
a radial axis y orthogonal to the longitudinal axis x as indicated by
coordinate axis in Figures 1-8. The longitudinal axis x is parallel to the
length L of the coil 110” (id.).
Claims 1, 2, 5, 7, 9-11, 14, 16, 18, 19, 21, 22, 25, 26, 28, 29, and 32
stand rejected and are on appeal (App. Br. 3). Claims 1, 10, 19, and 26, the
appealed independent claims, are representative and reads as follows:
1. A medical device comprising:
a coil having a longitudinal axis and a radial axis
orthogonal to the longitudinal axis, formed from a wire, the
wire comprising:
(a) a cross-section with a centroid;
(b) a moment of inertia with respect to an axis running
through the centroid and parallel to the
longitudinal axis of the coil; and
(c) a moment of inertia with respect to an axis running
through the centroid and parallel to the radial axis
of the coil, wherein the moment of inertia with
respect to an axis running through the centroid and
parallel to the longitudinal axis of the coil is
greater than the moment of inertia with respect to
an axis running through the centroid and parallel to
the radial axis of the coil.

10. A medical guidewire comprising:
(a) an elongated shaft including a proximal region
having a first outer diameter and a distal region
having a second outer diameter that is smaller than
the first outer diameter;
(b) a coil member connected to the elongated shaft at
the distal end of the proximal region and extending
from the distal end of the proximal region over at
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least a portion of the distal region, the coil member
having an inner diameter that is greater than the
second outer diameter, wherein the coil has a
longitudinal axis and a radial axis orthogonal to the
longitudinal axis, formed from a wire, the wire
comprising:
(i) a cross-section with a centroid;
(ii) a moment of inertia with respect to an axis
running through the centroid and parallel to
the longitudinal axis of the coil; and
(iii) a moment of inertia with respect to an axis
running through the centroid and parallel to
the radial axis of the coil, wherein the
moment of inertia with respect to an axis
running through the centroid and parallel to
the longitudinal axis of the coil is greater
than the moment of inertia with respect to an
axis running through the centroid and
parallel to the radial axis of the coil.

19. A medical device comprising:
a coil having a longitudinal axis and a radial axis
orthogonal to the longitudinal axis, formed from a composite
wire, the composite wire comprising:
(a) a cross-section with a centroid, a wire longitudinal
axis parallel to the coil longitudinal axis and a wire
radial axis parallel to the coil radial axis;
(b) a first material having a first Young’s Modulus at
the centroid; and
(c) a second material having a second Young’s
Modulus further away from the centroid along the
wire radial axis; wherein the second Young’s
Modulus is greater than the first Young’s Modulus.

26. A medical guidewire comprising:
(a) an elongated shaft including a proximal region
having a first outer diameter and a distal region
having a second outer diameter that is smaller than
the first outer diameter;
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(b) a coil member connected to the elongated shaft at
the distal end of the proximal region and extending
from the distal end of the proximal region over the
distal region, the coil member having an inner
diameter that is greater than the second outer
diameter, wherein the coil having a longitudinal
axis and a radial axis orthogonal to the longitudinal
axis, formed from a composite wire, the composite
wire comprising:
(i) a cross-section with a centroid, a wire
longitudinal axis parallel to the coil
longitudinal axis and a wire radial axis
parallel to the coil radial axis;
(ii) a first material having a first Young’s
Modulus at the centroid; and
(iii) a second material having a second Young’s
Modulus further away from the centroid
along the wire radial axis; wherein the
second Young's Modulus is greater than the
first Young’s Modulus.

The Examiner cites the following documents as evidence of
unpatentability:
Dobson US 5,724,989 Mar. 10, 1998
Samson et al. US 5,827,201 Oct. 27, 1998

The following rejection is before us for review:
Claims 1, 2, 5, 7, 9-11, 14, 16, 18, 19, 21, 22, 25, 26, 28, 29, and 32
stand rejected under 35 U.S.C. § 103(a) as being unpatentable over Samson
in view of Dobson (Ans. 3-7).3

3 Examiner’s Answer mailed May 23, 2007. We note that the Examiner has
rejected all of the pending claims using two somewhat overlapping
rationales, one of which was designated as a new ground of rejection (see
Ans. 4). While we will evaluate the merits of both rationales presented by
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OBVIOUSNESS
ISSUE
The Examiner finds that Samson discloses the device and guidewire
of claims 1 and 10, including a coil made of a wire that has a moment of
inertia with respect to the coil’s longitudinal x axis that is greater than the
moment of inertia with respect to the coil’s radial y axis (see Ans. 5). The
Examiner finds that Samson meets that limitation because Samson’s wire
has a cross section which “is a polygon, i.e. not symmetric, and more
material is distributed away from the longitudinal axis (the x-axis) without
less material being distributed away from the radial axis (the y-axis)” (id. at
5-6 (citing App. Br. 13-15)).
The Examiner concedes that Samson differs from the claims in that
Samson does not use a composite wire as a coil element as recited in claims
19 and 26, and cites Dobson to meet the limitation (Ans. 3-4). Specifically,
the Examiner finds that Dobson discloses a medical device with a coil
composed of a composite wire with a first material, stainless steel, at the
centroid, and a second material, tungsten, away from the centroid along the
radial axis (id. at 6).
The Examiner finds that Dobson’s wire meets the limitations of
claims 19 and 26 because the stainless steel at the wire’s centroid has a
Young’s Modulus which is less than the Young’s Modulus of the tungsten
material (id.). Based on the references’ teachings, the Examiner concludes
that a person of ordinary skill in the art would have considered it obvious to
modify Samson’s guidewire “with the medical guidewire as taught by
the Examiner, because the same claims were rejected over the same
references, we will not treat the rejections as separate rejections.
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Dobson for the purpose increasing the efficacy of the medical guidewire to
navigate tortuous vasculature thereby increasing patient safety during
advanced surgical procedures by configuring the material and mechanical
properties of medical guidewire” (id. at 7).
Appellant contends that Samson does not meet the limitations in
claims 1 and 10 regarding the wire’s moment of inertia (Reply Br. 5).
Specifically, Appellant argues, for the moment of inertia to be greater along
the x axis than the y axis, as required by claims 1 and 10, the wire must have
less material along the x axis than the y axis (see id.).
In contrast, Appellant urges, the ribbons coiled about Samson’s device
have a greater amount of material along the x axis than the y axis (id.).
Appellant further contends that Dobson’s wire does not remedy Samson’s
shortcoming in this respect because Dobson’s composite wire is symmetrical
and therefore the moments of inertia with respect to the x and y axes will be
the same, contrary to the requirements of claims 1 and 10 (App. Br. 12-13).
With respect to claims 19 and 26, Appellant urges that the claimed
configuration of materials “may give the coil increased torsional rigidity
without sacrificing the flexibility of the coil, thereby increasing the
torqueability/flexibility ratio of the coil” (Reply Br. 7 (citing Spec. 15:16-
28)). In contrast, Appellant argues, because the second material in Dobson’s
wire is distributed equally in all directions about the centroid “the
torqueability/flexibility ratio of the [coil] is not increased” (id.).
In view of the positions advanced by Appellant and the Examiner, the
issue with respect to this rejection is whether the Examiner erred in finding
that Samson and Dobson would have suggested a coil member encompassed
by claims 1, 10, 19, and 26 to a person of ordinary skill in the art.
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FINDINGS OF FACT
1. Claim 1 recites a medical device that has a coil with a longitudinal
axis and a radial axis orthogonal to the longitudinal axis. The coil is formed
from a wire that has a cross-section with a centroid.
Claim 1 limits the wire to one in which “the moment of inertia with
respect to an axis running through the centroid and parallel to the
longitudinal axis of the coil is greater than the moment of inertia with
respect to an axis running through the centroid and parallel to the radial axis
of the coil.”
2. Claim 10 recites a medical guidewire made, essentially, of an
elongated shaft covered at least in part by a coil formed from a wire with the
properties recited in claim 1.
3. Appellant’s Figure 3, reproduced below, “is a cross-sectional view of
an example coil 300” having features that we conclude are encompassed by
claim 1 (Spec. 12):

Figure 3 shows “coil 300 [which] has a longitudinal axis x, and a
radial axis y orthogonal to the longitudinal axis x and a lumen 307. The coil
300 is formed from a wire 305 having a cross-section. The coil 300
coordinate system can be transposed directly onto the wire 305 cross-
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section” (Spec. 12). As seen in Figure 3, “[t]he wire 305 cross-section is
shown as rectangular” (id.).
4. Appellant’s Figure 4, reproduced below, “is a cross-sectional view of
an example wire 400” encompassed by claims 1 and 10 (Spec. 12):

Figure 4 shows the wire’s cross-sectional area 401, which has a
“centroid 450[,] a longitudinal axis x parallel to the coil longitudinal axis,
and a radial axis y parallel to the coil radial axis and orthogonal to the
longitudinal axis x. The centroid 450 may be a point which defines the
geometric center of a cross-sectional surface area or object” (Spec. 12). As
seen in Figure 4, “[t]he longitudinal axis x intersects the radial axis y at the
centroid 450” (id.).
5. The Specification discloses that the wire’s cross sectional area has a
moment of inertia, termed Ix, with respect to an axis running through the
centroid and parallel to the longitudinal x axis (Spec. 12-13).
6. The Specification discloses that the wire’s cross sectional area has a
moment of inertia, termed Iy, with respect to an axis running through the
centroid and parallel to the radial y axis (id. at 13).
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7. These moments of inertia are defined, respectively, by the integrals
Ix = ∫ y2dA and Iy = ∫ x2dA, “in which x and y are the coordinates of the
differential elements of area dA” (id.).
8. Regarding the wire cross-section shown in Figure 4, “[t]he moment of
inertia Ix with respect to an axis running through the centroid 450 and
parallel to the longitudinal axis x of the coil is greater than the moment of
inertia Iy with respect to an axis running through the centroid 450 and
parallel to the radial axis y of the coil” (id.).
9. Thus, referring again to Figure 4, for a coiled wire with a rectangular
cross section to have a moment of inertia Ix greater than the moment of
inertia Iy, the longitudinal walls parallel to the x axis must be shorter than the
radial walls parallel to the y axis (id.).
10. Appellant’s Figure 5, reproduced below, “is a cross-sectional view of
an example wire 500 forming a coil” (id.):

Figure 5 shows elliptical cross sectional area 501 with centroid 550,
“a longitudinal axis x parallel to the coil longitudinal axis, and a radial axis y
parallel to the coil radial axis and orthogonal to the longitudinal axis x” (id.).
11. As also seen in Figure 5, “[t]he moment of inertia Ix with respect to an
axis running through the centroid 550 and parallel to the longitudinal axis x
of the coil is greater than the moment of inertia Iy with respect to an axis
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running through the centroid 550 and parallel to the radial axis y of the coil”
(id.). Thus, “[t]he cross-sectional area 501 shown corresponds to an ellipse
having longer radial walls 515 than longitudinal walls 510, 520” (id.).
12. Claim 19 recites a medical device that has a coil with a longitudinal
axis and a radial axis orthogonal to the longitudinal axis.
The coil is formed from a composite wire that has a cross-section with
a centroid. The wire’s cross-section has a longitudinal axis parallel to the
coil longitudinal axis and a radial axis parallel to the coil radial axis.
The composite wire is made from a first material having a first
Young’s Modulus at the centroid and a second material having a second
Young’s Modulus further away from the centroid along the wire radial axis.
The second Young’s Modulus must be greater than the first Young’s
Modulus.
13. Claim 26 recites a medical guidewire made, essentially, of an
elongated shaft covered at least in part by a coil formed from a wire with the
properties recited in claim 19.
14. Appellant’s Figure 7, reproduced below, shows a cross-section of a
composite wire that meets the limitations of claims 19 and 16:

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Figure 7 shows “first material 710 having a first Young’s Modulus . . .
disposed at the centroid 750 and a second material 720 having a second
Young’s Modulus . . . disposed further away from the centroid 750 than the
first material 710 along the wire radial axis y” (Spec. 14).
15. The Specification discloses that “[t]he second material’s 720 Young's
Modulus is greater than the first material’s 710 Young’s Modulus. Thus, the
second material 720 is stiffer than the first material” (id.).
16. Samson discloses “a guidewire suitable for introduction into the
vasculature of the brain” (Samson, col. 4, ll. 8-9).
17. Samson discloses:
The guidewire desirably is of four particular components and
may comprise others. The first component is a core wire of
either a super-elastic alloy, a stainless steel, or a composite of
both. The second component is a super-elastic ribbon braid
which surrounds a portion of the flexible core wire and changes
the mechanical properties of the device. The third component
is an optional, but desirable, distally located coil of a soft and
usually radio-opaque material terminated by an adhesive bead.
The fourth component is a polymeric layer placed over some or
all of the assembled metallic components which layer may be
coated with an additional lubricious polymer coating.
(Samson, col. 4, ll. 10-21.)
18. Figure 1 of Samson is reproduced below:

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Figure 1 shows guidewire 100 “made up of the wire core formed of a
flexible torqueable wire filament material . . . [with] distal end section (104)
of the core wire typically has an atraumatic distal tip (110), a fine wire coil
(112), and at least one adhesive joint (114)” (Samson, col. 5, ll. 12-30).
19. Samson discloses that wire coil 112 “may be radio-opaque and made
from materials including but not limited to platinum and its alloys. The
atraumatic distal tip (110) may be radio-opaque to allow knowledge of the
position of the coil (112) during the process of inserting the catheter and
traversal of the guidewire through the vasculature” (Samson, col. 5, ll. 30-
36).
20. Samson’s Figure 2 is reproduced below:

Figure 2 “shows a partial cutaway of the middle section of the
inventive guidewire (106) showing the core wire (130), a supporting ribbon
braid (132), and the polymeric covering (134)” (Samson, col. 5, ll. 59-62).
21. Samson discloses that the ribbons 206 that make up the braid 132
“provide specific physical strengths of various types, e.g., torsional rigidity,
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stiffness, kink resistance, composite elasticity, etc. The braid is placed
directly upon the wire core and is bonded directly to the core wire body in at
least two contact locations” (id. at col. 8, l. 63 through col. 9, l. 1).
22. Samson’s Figure 4 is reproduced below:

FIG. 4 shows a guidewire assembly (140) having a two-part
composite core made up of a super-elastic alloy proximal
portion (142) and a stainless steel distal section (144). The
super-elastic braid (146) provides controlled mechanical
support to the super-elastic core wire portion (142). A radio-
opaque distal coil (148) and a polymeric covering (150) are also
seen in the drawing.

(Samson, col. 7, ll. 54-60.)
23. Dobson discloses medical devices, including guidewires, that have “a
helical coil spring in which a length of the wire forming at least some of the
spring coils includes an annular layer of radiopaque material surrounding the
central cylindrical portion of the spring wire” (Dobson, col. 1, ll. 53-57).
24. Dobson’s Figure 3, reproduced below, “is a greatly enlarged sectional
view of the coil” (id. at col. 2, l. 17):

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Figure 3 “shows both annular layer 30 and the central portion 32 of
the stainless steel wire that the layer 30 circumferentially surrounds” (id. at
col. 3, ll. 34-36).
25. Dobson discloses that, in preferred embodiments, the wire’s outer
radiopaque portion is a thin layer of gold, which is ion-deposited onto a
stainless steel inner wire (id. at col. 4, ll. 4-16).
26. Dobson discloses that in “other embodiments, dense radiopaque
materials other than gold (e.g., platinum, tantalum, tungsten, iridium,
rhenium, or an alloy of two or more such materials) may be ion implanted to
form the desired increased radiopacity annular layers on the stainless steel
spring wire” (id. at col. 4, ll. 48-52).
27. The Examiner states that stainless steel has a Young’s Modulus
“typically ranging between 195-210 GPa” (Ans. 8 (citing App. Br. 16)), and
tungsten has a Young’s modulus which “typically ranges between 400-410
GPa, as is well known in the art” (id.).
Appellant does not dispute these figures.
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PRINCIPLES OF LAW
“During examination, the examiner bears the initial burden of
establishing a prima facie case of obviousness.” In re Kumar, 418 F.3d
1361, 1366 (Fed. Cir. 2005).
As the Supreme Court pointed out in KSR Int' l Co. v. Teleflex
Inc., 550 U.S. 398, 418 (2007), “a patent composed of several elements is
not proved obvious merely by demonstrating that each of its elements was,
independently, known in the prior art.” Rather, the Court stated:
[I]t can be important to identify a reason that would have
prompted a person of ordinary skill in the relevant field to
combine the elements in the way the claimed new invention
does . . . because inventions in most, if not all, instances rely
upon building blocks long since uncovered, and claimed
discoveries almost of necessity will be combinations of what, in
some sense, is already known.

Id. at 418-419 (emphasis added); see also id. at 418 (requiring a
determination of “whether there was an apparent reason to combine the
known elements in the fashion claimed by the patent at issue”) (emphasis
added).
While holding that some rationale must be supplied for a conclusion
of obviousness, the Supreme Court nonetheless emphasized a flexible
approach to the obviousness question, reasoning that the analysis under 35
U.S.C. § 103 “need not seek out precise teachings directed to the specific
subject matter of the challenged claim, for a court can take account of the
inferences and creative steps that a person of ordinary skill in the art would
employ.” Id. at 418; see also id. at 421 (“A person of ordinary skill is . . . a
person of ordinary creativity, not an automaton.”).
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Applying these concepts, the Court reaffirmed “that when a patent
‘simply arranges old elements with each performing the same function it had
been known to perform’ and yields no more than one would expect from
such an arrangement, the combination is obvious.” Id. at 417 (quoting
Sakraida v. Ag Pro, Inc., 425 U.S. 273, 282 (1976)).
Ultimately, therefore, “when the question is whether a patent claiming
the combination of elements of prior art is obvious,” the relevant inquiry is
“whether the improvement is more than the predictable use of prior art
elements according to their established functions.” Id.
Regarding claim interpretation, the PTO must interpret terms in a
claim using “the broadest reasonable meaning of the words in their ordinary
usage as they would be understood by one of ordinary skill in the art, taking
into account whatever enlightenment by way of definitions or otherwise that
may be afforded by the written description contained in the applicant’s
specification.” In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997).
Thus, “[c]laims are not to be read in a vacuum[;] while it is true they
are to be given the broadest reasonable interpretation during prosecution,
their terms still have to be given the meaning called for by the specification
of which they form a part.” In re Royka, 490 F.2d 981, 984 (CCPA 1974).
However, “while ‘the specification [should be used] to interpret the
meaning of a claim,’ courts must not ‘import[ ] limitations from the
specification into the claim.’ . . . [I]t is improper to ‘confin[e] the claims to
th[e] embodiments’ found in the specification . . . .” In re Trans Texas
Holdings Corp., 498 F.3d 1290, 1299 (Fed. Cir. 2007) (quoting Phillips v.
AWH Corp., 415 F.3d 1303, 1323 (Fed. Cir. 2005), citations omitted,
bracketed text in internal quotes in original); see also Sjolund v. Musland,
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847 F.2d 1573, 1581 (Fed. Cir. 1988) (“[W]hile it is true that claims are to
be interpreted in light of the specification and with a view to ascertaining the
invention, it does not follow that limitations from the specification may be
read into the claims.”); In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004)
(“[A]bsent claim language carrying a narrow meaning, the PTO should only
limit the claim based on the specification . . . when [it] expressly disclaim[s]
the broader definition.”).
ANALYSIS
We agree with Appellant that the Examiner erred in concluding that
claims 1 and 10 encompass the coiled elements suggested by Samson and
Dobson.
Claim 1 recites a medical device that includes a coil formed from a
wire having a cross-section in which “the moment of inertia with respect to
an axis running through the centroid and parallel to the longitudinal axis of
the coil is greater than the moment of inertia with respect to an axis running
through the centroid and parallel to the radial axis of the coil.”
Thus, for a coiled wire with a rectangular cross section to have a
moment of inertia Ix greater than the moment of inertia Iy, the longitudinal
walls parallel to the x axis must be shorter than the radial walls parallel to
the y axis (see FF 4-9). That is, for a wire with a rectangular cross section to
meet the requirements of claim 1, the shorter walls of the rectangle must be
parallel to the coil’s longitudinal axis and the longer walls of the rectangle
must be parallel to the coil’s radial axis.
In contrast, the ribbons 206 forming the braids 132 coiled around
Samson’s device are all aligned such that the rectangle’s longer walls are
parallel to the coil’s longitudinal axis (see FF 20, 22), an orientation
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opposite that required by claim 1. We therefore do not agree with the
Examiner that the coiled ribbons of Samson’s device meet the requirements
of claim 1.
Regarding wires with non-polygonal cross-sections, a wire with an
elliptical cross-section would meet the requirements of claim 1 if the ellipse
were aligned such that the longer walls were aligned along the coil’s radial
axis, and the shorter walls were aligned along the longitudinal axis (see FF
10, 11). However, the Examiner has not explained how any of Samson’s
coiled wires with non-polygonal cross-sections, such as coil 148 (FF 22),
meet that requirement.
Rather, Samson’s non-polygonal coiled wires all appear to be circular
in cross-section, which would not meet claim 1, since the distance between
the centroid and the wire’s edge along the x and y axes would be identical,
therefore resulting in an identical moment of inertia, as defined in
Appellant’s Specification (see FF 7). Also, Dobson’s composite coiled
wires do not remedy this deficiency, as they are also circular (see FF 24).
The Examiner argues that Samson’s coiled wires meet the
requirements of claim 1 because they have polygonal cross sections with
“more material . . . distributed away from the longitudinal axis (the x-axis)
without less material being distributed away from the radial axis (the y-
axis)” (Ans. 5-6 (citing App. Br. 13-15)). We are not persuaded by this
argument.
The Examiner appears to be basing this claim interpretation on an
erroneous understanding of a statement in the Appeal Brief. Appellant states
on page 13 of the Appeal Brief, that, “[i]n order to change the ratio [of the
moments of inertia Ix and Iy], more material would need to be moved away
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from the x-axis (longitudinal axis) without moving the same or greater
amount of material away from the y-axis (radial axis), or vise versa” (App.
Br. 13).
However, as is evident from the discussion above, Appellant’s
Specification makes it clear that, for a wire to meet the requirements of
claim 1, there must be less material along the longitudinal, or x axis, and
more material along the radial, or y axis (see FF 3-11). As discussed above,
Samson’s coiled wires do not have the required orientation, and Dobson
does not remedy this deficiency in Samson.
In sum, we reverse the Examiner’s rejection of claim 1, and its
dependent claims 2, 5, 7, and 9, as being obvious in view of Samson and
Dobson. Because the guidewire of claim 10 requires a coil with the
properties recited in claim 1, we also reverse the Examiner’s obviousness
rejection of claim 10 and its dependent claims 11, 14, 16, and 18.
Appellant’s arguments do not persuade us, however, that the
Examiner erred in concluding that claims 19 and 26 encompass the coiled
elements of Dobson’s device.
Claim 19 recites a medical device that has a coiled composite wire
made from a first material having a first Young’s Modulus at the cross-
sectional centroid and a second material having a second Young’s Modulus
further away from the centroid along the wire’s radial axis. Claim 19 also
requires the second Young’s Modulus to be greater than the first Young’s
Modulus. That is, the material away from the centroid must be stiffer than
the material at the centroid (see FF 15).
Appellant argues that Dobson fails to meet the requirements of claim
19 because Dobson uses a stainless steel inner wire coated with gold, the
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gold having a much lower Young’s Modulus than stainless steel (App. Br.
16). We are not persuaded by this argument.
As the Examiner points out, Dobson teaches that tungsten may be
used as the outer radiopaque coating for its wire, instead of gold (FF 26). As
the Examiner further points out, and Appellant does not dispute, the Young’s
Modulus of tungsten is greater than stainless steel (FF 27).
Thus, Dobson teaches a coiled wire with a first material, stainless
steel, at the wire’s cross-sectional centroid, and a stiffer second material,
tungsten, away from the centroid along the radial axis (FF 24, 26). We
therefore agree with the Examiner that Dobson suggests using, in a medical
device, a coiled wire with the properties required by claim 19.
Appellant argues that using materials with the properties recited in
claim 19 “may give the coil increased torsional rigidity without sacrificing
the flexibility of the coil, thereby increasing the torqueability/flexibility ratio
of the coil” (Reply Br. 7 (citing Spec. 15:16-28)). In contrast, Appellant
argues, “[t]he multi-layer wire of the spring 14 taught in Dobson does not
possess the notable characteristics of the claimed coil. Namely, material
distribution around the centroid of the cross-section of the spring 14 is equal
in all directions. Thus, the torqueability/flexibility ratio of the spring 14 is
not increased” (id.).
We are not persuaded by this argument. We note the Specification’s
assertion of the torqueability/flexibility advantages of using coiled wires in
which material is removed from the x axis “without moving the same
amount of material away from the centroid and y-axis” (Spec. 15).
However, the Specification states that these advantages inhere from having a
greater moment of inertia about the x axis than the y axis (see id.).
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Application 10/647,613

In contrast to claim 1, however, claim 19 does not require the wire to
have a cross section in which the moment of inertia along the x axis is
greater than the moment of inertia along the y axis. Nor does claim 19 recite
any limitation directed to torqueability or flexibility. Rather, claim 19
merely requires the wire to have a stiffer material away from the centroid
along the radial axis, and does not exclude the stiffer material from being
present along the longitudinal axis.
Claim 19 therefore encompasses wires with symmetrical
cross-sections, including Dobson’s symmetrical composite wire.
Accordingly, we are not persuaded that the Examiner failed to make a prima
facie case of obviousness with respect to claim 19.
Thus, we affirm the Examiner’s rejection of claim 19 as obvious in
view of Samson and Dobson. Because they were not argued separately,
claims 25, 26, and 32 fall with claim 19. See 37 C.F.R. § 41.37(c)(1)(vii).
Appellant separately argues that claims 21, 22, 28, and 29 are
unobvious over the cited references (App. Br. 17). We select claim 22 as
representative of the argued group of claims. See 37 C.F.R. 41.37(c)(1)(vii).
Claim 22 recites “[t]he medical device according to claim 19, wherein
the wire cross-section is a rectangular shape.”
Appellant argues that the Examiner misinterpreted the rectangular
ribbons constituting the braid portion 132 of Samson’s as being part of the
coil 112 or 148 (App. Br. 17-18; see also FF 18-22). Appellant’s argument
does not persuade us that the Examiner’s conclusion of obviousness is in
error.
Dobson discloses the suitability of providing a coiled wire on an
intraluminal medical device, such as a guidewire, with a radiopaque coating
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Appeal 2009-0388
Application 10/647,613

to make the device detectable when inserted (see FF 23). Samson discloses
that such detectability is also desirable on its devices (FF 19). In view of
these teachings we conclude that a person of ordinary skill in the art would
have considered it obvious to include a radiopaque coating on rectangular
cross-sectioned wires, such as those used on Samson’s device, to allow
detection of the wire while inserted in a patient.
We therefore affirm the Examiner’s rejection of claim 22 as being
obvious over Samson and Dobson. Because they were not argued
separately, claims 21, 28, and 29 fall with claim 22. See 37 C.F.R.
§ 41.37(c)(1)(vii).
SUMMARY
We reverse the Examiner’s rejection of claims 1, 2, 5, 7, 9-11, 14, 16,
and 18, under 35 U.S.C. § 103(a) as being unpatentable over Samson in view
of Dobson.
However, we affirm the Examiner’s rejection of claims 19, 21, 22, 25,
26, 28, 29, and 32, as being obvious over those references.
TIME PERIOD
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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