Ex Parte Popadiuk et al

Board of Patent Appeals and Interferences

May 17, 2012

11169868 (B.P.A.I. May. 17, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte NICHOLAS M. POPADIUK, DAVID LINDH, SR.,
and DOMINICK EGIDIO
__________

Appeal 2011-001633
Application 11/169,868
Technology Center 3700
__________

Before DEMETRA J. MILLS, JEFFREY N. FREDMAN, and
STEPHEN WALSH, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a barbed
monofilament and a method for forming a barbed monofilament. The
Examiner rejected the claims as obvious. We have jurisdiction under 35
U.S.C. § 6(b). We reverse.

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Application 11/169,868

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Statement of the Case
Background
The Specification teaches that “many wounds and surgical incisions
are closed using surgical sutures of some sort. Sutures are also commonly
used in many other surgical applications” (Spec. 1, ll. 7-9). According to the
Specification, the “present invention relates generally to the field of surgical
sutures, and more particularly to a barbed surgical suture having a triangular
primary cross-section” (Spec. 1, ll. 3-5).
The Claims
Claims 1-5, 7-12, 15-23, and 26-32 are on appeal. Claim 1 is
representative and reads as follows:
1. A barbed monofilament comprising a triangular
primary cross-section defined by a periphery including
first, second and third points of said triangle, and a
plurality of barbs formed therein, wherein successive
barbs are staggered around the periphery of the
monofilament, and extend inwardly into the
monofilament to a predetermined depth from the first,
second and third points respectively, and wherein a distal
portion of each barb is defined by a cut extending at an
angle relative to a longitudinal axis of the monofilament,
and a proximal portion of each barb is defined by a cut
extending at an angle of approximately zero degrees
relative to the longitudinal axis of the monofilament,
wherein the barbed monofilament is comprised of
a non-absorbable material selected from the group
consisting of polyolefins, polyamides and polyvinylidene
fluoride, and wherein the barbed monofilament is
adapted for use as an implantable surgical suture for
approximating tissue.

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The issue

The Examiner rejected claims 1-5, 7-12, 15-23, and 26-32 under 35
U.S.C. § 103(a) as obvious over Metz,
1
Brumlik,
2
and Leung
3
(Ans. 3-6).
The Examiner finds that Metz teaches “a barbed monofilament
comprising a substantially equilateral triangular cross section defined by a
periphery including first, second, and third points of a triangle” (Ans. 3).
The Examiner finds that the monofilament comprises “a plurality of barbs
staggered around the periphery of the monofilament at approximately 120
degree intervals and extending inwardly into the monofilament to a
predetermined depth from the first, second, and third points”(id.).
The Examiner finds that “Brumlik discloses a filament (Fig 12) with a
barb (39) configuration, wherein the barb is defined by a first cut extending
at an angle relative to the longitudinal axis and a proximal portion defined
by a cut extending at an angle of approximately zero degrees” (id. at 4). The
Examiner finds that Leung teaches “a similar barbed monofilament . . . and
teaches it may be formed from a non-absorbable material such as a
polyamide . . . or from an absorbable material such as polydioxinone” (id. at
6).
The Examiner finds it obvious
to modify the device of Metz such that the proximal portion
of the barb was defined by a cut angle extending at
approximately zero degrees relative to the longitudinal axis

1
Metz, G., DE 1810800, published Jun. 4, 1970.
2
Brumlik, G., US 3,981,051, issued Sep. 21, 1976.
3
Leung et al., US 2004/0060410 A1, published Apr. 1, 2004.
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Application 11/169,868

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of the monofilament. Such a modification would ensure the
barb does not extend past the desired cut depth to preserve
the strength of the monofilament. Additionally, such a
modification may improve the ability of the barb to embed
within the target substrate, or tissue, since the barbs may
extend deeper into the substrate.

(Ans. 4.)
Appellants contend that other than Figure 12, Brumlik is “entirely
devoid of any written description as to the cut geometry of this illustration,
and provides no teachings whatsoever of providing a parallel cut portion or
why such a cut portion would be desirable” (App. Br. 6). Appellants submit
that “it is irrelevant and unnecessary in the context of Brumlik where
thousands of tiny bristles act together to achieve holding power, as opposed
to a single monofilament in the context of a surgical suture” (id. at 7).
Appellants
submit that this is the classic application of hindsight where
the Examiner has taken the teachings of the present
application itself regarding the specifically disclosed cut
geometry and its advantages in the context of a surgical
suture, used that teaching itself to piece together a picture
from the prior art (including non-analogous prior art).

(Id.)
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that Metz, Brumlik, and Leung render
obvious a “barbed monofilament” where “a proximal portion of each barb is
defined by a cut extending at an angle of approximately zero degrees relative
to the longitudinal axis of the monofilament” as required by claim 1?

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Findings of Fact
1. The Specification teaches that the “barb forming step may also
further include, for each barb, following the angled cutting step, further
cutting the monofilament for a predetermined distance at an angle of
approximately 0 degrees relative to the longitudinal axis of the
monofilament” (Spec. 3, ll. 12-15).
2. Metz teaches “steel wires provided with barbs and spiral
needles to suture tendons” (Metz 1).
3. Figure 1E of Metz is reproduced below:

Figure 1E of Metz shows “a wire with non-round cross-section, e.g.
triangular” (Metz 3).
4. Metz teaches that “wires with at least one barb are indicated for
both stumps of the tendon” (Metz 3).
5. Brumlik teaches “self-gripping devices and in particular to a
novel and improved self-gripping device which is operative to grip a
receiving layer upon contact therewith in a self-gripping action” (Brumlik,
col. 1, ll. 11-14).
6. Figure 12 of Brumlik as annotated by the Examiner is
reproduced below:
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“FIG. 12 is an elevational view on an enlarged scale of a portion of a
gripping element” (Brumlik, col. 2, ll. 31-32).
7. Brumlik teaches that “the barbs 22, 24 serving to anchor the
gripping element within the base” (Brumlik, col. 3, ll. 58-60).
8. Leung teaches “a barbed suture useful for connecting bodily
tissue in various surgical contexts” (Leung 1 ¶ 0001).
9. Leung teaches that “bio-absorbable polymers include, but are
not limited to, polydioxanone . . . . Barbed sutures made from such bio-
absorbable materials are useful in a wide range of applications” (Leung 3 ¶
0055).
10. Leung teaches that “barbed sutures may be formed from a non-
absorbable material, which may be a polymer. Such polymers include, but
are not limited to . . . polyamide” (Leung 3 ¶ 0056).
Principles of Law
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or
argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993).
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“[R]ejections on obviousness grounds cannot be sustained by mere
conclusory statements; instead, there must be some articulated reasoning
with some rational underpinning to support the legal conclusion of
obviousness.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007).
Analysis
Appellants contend that Brumlik “provides no teachings whatsoever
of providing a parallel cut portion or why such a cut portion would be
desirable” (App. Br. 6). Appellants contend that “the Examiner has taken
the teachings of the present application itself regarding the specifically
disclosed cut geometry and its advantages in the context of a surgical suture,
used that teaching itself to piece together a picture from the prior art
(including non-analogous prior art)” (id. at 7).
We agree with Appellants. The Examiner’s reason to modify the barbs
of Metz or Leung to use a zero degree cut as shown in Figure 12 of Brumlik
is that the “modification may improve the ability of the barb to embed within
the target substrate” (Ans. 4). This reason, however, finds no basis in any of
the references, nor does the Examiner proffer any evidence that a zero
degree angle would result or be expected to result in the argued improved
embedding into tissue based on the prior art.
In addition, we agree with Appellants that Brumlik is not analogous
art to Metz and Leung. The test for non-analogous art is first whether the art
is within the field of the inventor's endeavor and, if not, whether it is
“reasonably pertinent to the particular problem with which the inventor was
involved.” In re Wood, 599 F.2d 1032, 1036 (CCPA 1979). “A reference is
reasonably pertinent if, even though it may be in a different field” of
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endeavor, it logically would have commended itself to an inventor's
attention in considering his problem “because of the matter with which it
deals.” In re Clay, 966 F.2d 656, 659 (Fed. Cir. 1992).
There can be no reasonable dispute that sutures are not in the same
field of endeavor as self-gripping devices. Therefore, the issue is whether
Brumlik was pertinent to Metz and Leung. The Examiner does not identify,
and we do not find, any reason why the barbs of Brumlik were pertinent to
the sutures of Metz and Leung. The Examiner does not provide any
evidence that the barbs of Brumlik would have any superior characteristics
relevant to sutures. We therefore agree with Appellants that these references
are nonanalogous.
Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that Metz, Brumlik, and Leung render obvious a “barbed monofilament”
where “a proximal portion of each barb is defined by a cut extending at an
angle of approximately zero degrees relative to the longitudinal axis of the
monofilament” as required by claim 1.
SUMMARY
In summary, we reverse the rejection of claims 1-5, 7-12, 15-23, and
26-32 under 35 U.S.C. § 103(a) as obvious over Metz, Brumlik, and Leung.

REVERSED

cdc