Ex Parte Igaki

Board of Patent Appeals and Interferences

Apr 12, 2010

10287752 (B.P.A.I. Apr. 12, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte KEIJI IGAKI
____________

Appeal 2009-005300
Application 10/287,752
Patent 5,762,625
Technology Center 3700
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Decided: April 12, 2010
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Before: WILLIAM F. PATE, III, JENNIFER D. BAHR, and MICHAEL W.
O'NEILL, Administrative Patent Judges.

BAHR, Administrative Patent Judge.

DECISION ON APPEAL
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STATEMENT OF THE CASE
Keiji Igaki (Appellant) appeals under 35 U.S.C. § 134 (2002) from the
Examiner's decision rejecting reissue claims 1-11. We have jurisdiction
over this appeal under 35 U.S.C. § 6 (2002).

The Invention
Appellant's claimed invention is directed to a luminal stent made of a
continuous bioabsorbable polymer fiber formed in a non-woven, non-knitted
tube. Col. 1, ll. 49-53.
Claim 1, reproduced below, is illustrative of the claimed invention.
1. A luminal stent formed from a single,
continuous yarn of continuous bioabsorbable
polymer fibers in a non-woven, non-knitted, and
meandering state in a shape conforming to a tube.

The Rejections
The Examiner relies on the following references:
Tang US 4,920,203 Apr. 24, 1990
MacGregor US 4,994,071 Feb. 19, 1991
Goldberg CA 2,025,626 Mar. 28, 1991
MacGregor US 5,015,253 May 14, 1991
Pinchuk US 5,019,090 May 28, 1991

Appellant seeks review of the Examiner's rejections under 35 U.S.C.
§ 103(a) of claims 1, 3, 4, and 7-11 as unpatentable over Pinchuk and Tang;
of claim 2 as unpatentable over Pinchuk, Tang, and MacGregor ('253); of
claim 5 as unpatentable over Pinchuk, Tang, and Goldberg; and of claim 6 as
unpatentable over Pinchuk, Tang, and MacGregor ('071).

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SUMMARY OF DECISION
We AFFIRM.

ISSUE
Claim 1 requires a stent made of a continuous bio-absorbable polymer
yarn formed in a "non-woven, non-knitted, and meandering state." The
Examiner found that Pinchuk describes a stent made of a continuous bio-
absorbable polymer strand formed in a non-woven, non-knitted, and
meandering state. Ans. 3. The Examiner found it was well known to form a
strand from a plurality of fibers to make yarn, and that Tang describes a
biodegradable polymer yarn used in a medical stent. Id. The Examiner
concluded that it would have been obvious to use a biodegradable yarn as
taught in Tang instead of the strand in Pinchuk in order to increase the
strength of the strand. Ans. 3-4.
Appellant argues that Pinchuk's stent has a weave or a knot (Reply Br.
3), or is formed from a series of interwoven lengths of yarn (Appeal Br. 6-8),
and thus is not "non-woven" or "non-knitted." Appellant also argues that
Tang does not describe a stent (Reply Br. 4-5), and that neither reference
provides motivation to use a yarn as taught in Tang instead of the strand of
Pinchuk. Reply Br. 5-7. Appellant additionally argues that Pinchuk
discloses a stent having a circular, or helical, structure, and thus is not a stent
having a "meandering state." Reply Br. 4. Appellant argues claims 8-11, 2,
5, and 6 as separate groups, but relies on the argument presented with
respect to claim 1. Reply Br. 7-8. Thus, the outcome with respect to claim 1
will control the outcome with respect to claims 2, 5, 6, and 8. In addition,
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claims 3, 4, and 7 stand or fall with claim 1, and claims 9-11 stand or fall
with claim 8. 37 C.F.R. § 41.37(c)(1)(vii) (2007).
Therefore, the dispositive issues in this appeal are whether Pinchuk
describes a stent formed in a "non-woven, non-knitted, and meandering
state" and whether the Examiner has established that it would have been
obvious to one of ordinary skill in the art to modify Pinchuk's stent formed
from a strand to be formed from a yarn, such as is described in Tang.

FACTS PERTINENT TO THE ISSUES
(FINDINGS-OF-FACT (FF))
FF1 Pinchuk describes a stent formed from a continuous, undulating
length 33 wound helically around a mandrel 41 to form a number of
circumferential sections 32 defining the length of stent 31. Col. 5, ll.
15-52, fig. 2, depicting undulating length 33, fig. 3, depicting
undulating length 33 wrapped around mandrel 41 to form stent 31.
When the helical winding is finished, the two loose ends 43 are
hooked or welded to the adjacent circumferential section 32. Col. 5,
ll. 53-66, fig. 5, depicting a close-up of end 43 hooked to adjacent
circumferential section 32.
FF2 A dictionary definition of "weave" is "[t]o make cloth by interlacing
strands of warp and filling threads" (McGraw-Hill Dictionary of
Scientific and Technical Terms, 2158 (Sybil P. Parker, ed., 5th ed.
1994)); or "to form (cloth) by interlacing strands (as of yarn); specif:
to make (cloth) on a loom by interlacing warp and filling threads"
(Webster's Ninth New Collegiate Dictionary, 1336 (Frederick C. Mish
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et al. eds., 1988)). Thus, a "weave" requires two separate lengths of
thread or yarn: the warp, and the filling.
FF3 A dictionary definition of "knit" is "[m]aking a fabric by interlocking
loops of yarn by means of needles or wires" (McGraw-Hill Dictionary
of Scientific and Technical Terms, 1092 (Sybil P. Parker, ed., 5th ed.,
1994)) or "to form by interlacing yarn or thread in a series of
connected loops with needles" (Webster's Ninth New Collegiate
Dictionary, 664 (Frederick C. Mish et al. eds., 1988)). Thus, a "knit"
material requires an interlocked series of loops.
FF4 "Woven" fabric, in the textile art, is
[f]abric[] composed of two sets of yarns. One set
of yarns, the warp, runs along the length of the
fabric. The other set of yarns, the fill or weft, is
perpendicular to the warp. Woven fabrics are held
together by weaving the warp and the fill yarns
over and under each other.
"Textile Dictionary," http://www.fabriclink.com/Dictionaries/
Textile.cfm (last accessed Apr. 1, 2010).
FF5 "Knit" fabric, in the textile art, is
[f]abric[] made from only one set of yarns, all
running in the same direction. Some knits have
their yarns running along the length of the fabric,
while others have their yarns running across the
width of the fabric. Knit fabrics are held together
by looping the yarns around each other. Knitting
creates ridges in the resulting fabric. Wales are the
ridges that run lengthwise in the fabric; courses run
crosswise.
"Textile Dictionary," http://www.fabriclink.com/Dictionaries/
Textile.cfm (last accessed Apr. 1, 2010).
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FF6 A dictionary definition of "meandering" is "to follow a winding or
intricate course." Webster's Ninth New Collegiate Dictionary, 736
(Frederick C. Mish et al. eds., 1988).
FF7 Tang describes a yarn made of a biodegradable biopolymer, formed
into a fibrous device to be used in woven, knitted, or non-woven
articles. Col. 5, ll. 21-43, and particularly col. 5, l. 35 referring to
devices constructed of "non-woven" fabric. One embodiment
includes vascular stents. Col. 5, l. 64.

PRINCIPLES OF LAW
Rejections on obviousness grounds must be supported by "some
articulated reasoning with some rational underpinning" to combine the
known elements in the manner required in the claim at issue. In re Kahn,
441 F.3d 977, 988 (Fed. Cir. 2006) cited with approval in KSR Int’l Co. v.
Teleflex Inc., 550 U.S. 398, 418 (2007). However, "the analysis 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." KSR, 550 U.S.
at 418.
"[A] person of ordinary skill has good reason to pursue the known
options within his or her technical grasp. If this leads to the anticipated
success, it is likely the product not of innovation but of ordinary skill and
common sense." Id. at 421.
Further, "if a technique has been used to improve one device, and a
person of ordinary skill in the art would recognize that it would improve
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similar devices in the same way, using the technique is obvious unless its
actual application is beyond his or her skill." Id. at 417.

ANALYSIS
Pinchuk describes a stent formed from a continuous, helically
wrapped strand of biodegradable material. FF1. A strand is formed into an
undulating series of expandable sections that are then wound in a helical
manner to create continuous series of circumferential sections forming the
stent. Id. To prevent loose ends, each end circumferential section hooks
onto or is welded to the adjacent circumferential section. Id.
Appellant first argues that Pinchuk's stent is formed from multiple
interwoven lengths of yarns. Appeal Br. 6-8. However, as pointed out by
the Examiner (Ans. 6), Pinchuk describes a stent formed from a single
continuous strand that is helically wrapped, with only the two ends hooked
or welded (see also FF1). Appellant does not further contest the Examiner's
finding in the Reply Brief.
Appellant considers the single hook on each circumferential section to
vitiate Pinchuk's ability to be considered "non-woven" or "non-knitted."
Reply Br. 3-4. As such, Appellant would appear to consider any crossing of
a strand to be "woven" or "knitted."
In general, a woven material is made from a series of parallel warp
strands running the length of the material, with a weft strand being woven
above and below each of the warp strands to form the material. FF2; FF4.
Knitted materials, on the other hand, are formed from a series of consecutive
loops of a single strand. FF3; FF5. The record before us does not indicate
that the nomenclature as applied to stents differs.
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Thus, a "woven" stent is a stent made using warp and filling strands.
As such, Pinchuk's stent is clearly distinguishable from a woven stent
because it does not utilize warps and fillings, but rather, is made from a
single strand. FF1; cf. FF2, FF4. Similarly, a "knitted" stent is a stent made
using a series of interconnected loops. Pinchuk's stent is not knitted because
the stent is formed from a series of unconnected loops. FF1. While the very
ends of Pinchuk's stent are hooked to an adjacent loop, this single hook does
not form a series of unconnected loops. Id.; cf. FF3, FF5. In addition,
Pinchuk's end hooks could also be welded to an adjacent section, which
would not form a loop at all. FF1. Further, if anything that contained one
single loop was "knitted" then virtually every knot, hitch, or crossed strand
would be considered to be formed as a "knitted" material, rendering the
term, as distinguishing knitted materials from other textiles, superfluous.
See Stumbo v. Eastman Outdoors, Inc., 508 F.3d 1358, 1362 (Fed. Cir.
2007) (denouncing claim constructions that render phrases in claims
superfluous). Therefore, Pinchuk's stent would not be considered "woven"
or "knitted" by one of ordinary skill in the art.
Appellant argues that Pinchuk does not describe a yarn in a
"meandering state." Reply Br. 4. In particular, Appellant references figure
2 of Appellant's disclosure, which depicts a particular "meandering" "loop-
back structure." Id. However, claim 1 does not require a "loop-back
structure," or any other particular shape. See In re Self, 671 F.2d 1344, 1348
(CCPA 1982) (limitations not appearing in the claims cannot be relied upon
for patentability). Rather, claim 1 merely requires that the yarn be in a
"meandering state." Appellant's Specification, somewhat contradictorily,
states that the yarn is "entwined around the peripheral surface of the tubular
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member," not "in the wound or coiled state," but "meandered or coiled into
one or more loops." Spec., col. 3, l. 4-12. Thus, the Specification does not
specially define the term "meandering." In re Paulsen, 30 F.3d 1475, 1480
(Fed. Cir. 1994) (requiring special definitions to "be done with reasonable
clarity, deliberateness, and precision").
According to the plain meaning of "meandering," a stent formed from
a "meandering" yarn could be formed of a yarn that follows a winding
course. See FF6. In the Examiner's proposed combination, Pinchuk
describes a length that winds back and forth (undulating length 33) and is
coiled into several loops (circumferential sections 32) around the peripheral
surface of the tubular mandrel (41). See FF1; Ans. 3-4. Therefore, the
combined teachings of Pinchuk and Tang describe the limitation of claim 1
requiring that the yarn be in a "meandering state."
Appellant further argues that the fibers and yarns of Tang are
designed for flexible materials, not rigid materials like stents. Reply Br. 4-5.
However, Tang explicitly considers vascular stents. FF7.
Lastly, Appellant argues that neither Pinchuk nor Tang provides
motivation to use a yarn as described in Tang in Pinchuk's stent. Reply Br.
5-7. This argument is not convincing because the Supreme Court has stated
that a rigid insistence on teaching, suggestion, or motivation is incompatible
with its precedent concerning obviousness. See KSR, 550 U.S. at 419.
Moreover, in making this argument, Appellant has failed to take into
consideration the fact that Tang explicitly contemplates vascular stents. See
FF7. As the Examiner found, yarn provides certain advantages that a single
strand does not provide, such as increased strength. Ans. 3. See KSR, 550
U.S. at 417 (it is generally obvious to improve similar devices in similar
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ways). Accordingly, the evidence establishes an apparent reason to make
the proposed combination. Appellant does not provide any evidence that the
proposed combination would have been beyond the technical grasp of a
person of ordinary skill in the art, or yielded results that could not have been
predicted by a person of ordinary skill in the art.

CONCLUSION
The record before us indicates that Pinchuk describes a stent formed
in a "non-woven, non-knitted, and meandering state" and that it would have
been obvious to substitute the single strand of material in the non-woven,
non-knitted stent described in Pinchuk with yarn, as taught in Tang, in order
to increase the strength of the stent.

DECISION
The Examiner's decision is affirmed as to claims 1-11.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv) (2007).

AFFIRMED

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