Jesse Nawrocki et al.

Patent Trials and Appeals Board

Jul 29, 2020

13621625 - (D) (P.T.A.B. Jul. 29, 2020)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/621,625 09/17/2012 Jesse G. Nawrocki ETH5641USCIP1 3883
73119 7590 07/29/2020
Doherty IP Law Group LLC
37 Belvidere Avenue
Washington, NJ 07882
EXAMINER
WEISBERG, AMY REGINA
ART UNIT PAPER NUMBER
3649
MAIL DATE DELIVERY MODE
07/29/2020 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________

Ex parte JESSE G. NAWROCKI, JASON T. PERKINS,
and DAVID C. LINDH SR.
____________

Appeal 2020-000593
Application 13/621,625
Technology Center 3600
____________

Before JOHN C. KERINS, JEREMY M. PLENZLER, and LISA M. GUIJT,
Administrative Patent Judges.

GUIJT, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Appellant1 seeks our review under 35 U.S.C. § 134(a) of the rejection
of claims 1–9 and 11–21. We have jurisdiction under 35 U.S.C. § 6(b).

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies Ethicon, Inc. as the real party in interest.
Appeal Br. 2.
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We REVERSE and enter NEW GROUNDS OF REJECTION under
35 U.S.C. § 103(a) of claims 1–9, 11–13, 15, 16, 20, and 21 as unpatentable
over Morency and Nawrocki, and of claims 14 and 17–19 as unpatentable
over Morency, Nawrocki, and Bonutti; all pursuant to our authority under 37
C.F.R. § 41.50(b).
THE INVENTION
Appellant’s invention relates to “barbed sutures having barbs that are
specifically designed to facilitate passage through tissue when pulled in a
first direction and that exhibit maximum holding strength when pulled in an
opposite, second direction.” Spec. ¶ 2. Claims 1, 15, and 20 are the
independent claims on appeal. Claim 1, reproduced below, is illustrative of
the subject matter on appeal.
1. A wound closure device comprising:
a filamentary element having a proximal and distal end;
and
a plurality of barbs extending outwardly from said
filamentary element, each said barb having a base connected with
said filamentary element, a tip spaced from said base and facing
toward the distal end of said filamentary element, an outer edge
facing away from said filamentary element that extends between
said base and said tip, and an inner edge facing toward said
filamentary element that extends between said base and said tip,
wherein said outer edge includes a first section having a concave
surface that extends between said base and a transition point of
said barb and a second section having a convex curved surface
that extends from said transition point of said barb to a distal-
most portion of said tip of said barb and wherein said inner edge
of said barb has a concave surface that extend to said tip of said
barb;
wherein said plurality of barbs include a first barb and a
second barb that is adjacent and distal to said first barb, said first
and second barbs extending outwardly from a same side of said
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filamentary element and having tips facing toward the distal end
of said filamentary element, wherein said filamentary element
has an outer surface that extends distally from a concave surface
of an inner edge of said first barb to an outer edge of said second
barb, said outer edge of said second barb including a first section
having a concave surface that extends between a base and a
transition point of said second barb and a second section having
a convex curved surface that extend from said transition point of
said second barb to a distal-most portion of said tip of said second
barb;
a needle secured to the proximal end of said filamentary
element; and
a stop element connected with the distal end of said
filamentary element.

THE REJECTIONS
The Examiner relies upon the following as evidence in support of the
rejections:
NAME REFERENCE DATE
Bonutti RE 36,974 Nov. 28, 2000
Popadiuk US 2007/0005109 A1 Jan. 04, 2007
Nawrocki US 2008/0312688 A1 Dec. 18, 2008
Morency US 2010/0146770 A1 June 17, 2010
The following rejections are before us for review:
I. Claims 1–9, 11–13, 15, 20, and 21 stand rejected under
35 U.S.C. § 103(a) as being unpatentable over Morency
and Nawrocki.
II. Claims 14 and 17–19 stand rejected under 35 U.S.C.
§ 103(a) as being unpatentable over Morency, Nawrocki,
and Bonutti.
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III. Claims 16 stands rejected under 35 U.S.C. § 103(a) as
being unpatentable over Morency, Nawrocki, and
Popadiuk.

OPINION
Rejection I
Regarding independent claim 1, the Examiner finds that Morency
discloses a wound closure device, as claimed, except that Morency fails to
disclose that the outer edge of each barb, which faces away from the
filamentary element and extends between the base and the tip of the barb,
includes “a first section having a concave surface that extends between said
base and a transition point of said barb,” as claimed. Final Act. 3 (citing
Morency, Figs. 7A, 7B). The Examiner relies on Nawrocki’s Figure 2 for
teaching this limitation and, in support, provides the magnified, annotated
Figure 2 of Nawrocki reproduced below. Id.

The Examiner’s magnified, annotated Figure 2 of Nawrocki shows a
filamentary element with a barb, wherein the Examiner identifies concave
and convex surfaces, with a transition point therebetween, on the outer edge
of a barb. The Examiner reasons that it would have been obvious “to modify
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the barb shape of Morency, to have the shape as taught by Nawrocki, as
Nawrocki teaches barbs (204) as they are able to bend and flatten as pulled
through tissue.” Id. at 3–4 (citing Nawrocki ¶ 25).
Appellant argues that Nawrocki’s Figure 2 fails to depict the claimed
surface, as relied on by the Examiner. Appeal Br. 15–17; Reply Br. 2–6. In
particular, Appellant argues that “the Examiner’s interpretation of the claims
makes no distinction between the filamentary element and the outer edge of
the barb, and does not recognize that the independent claims include
limitations for distinguishing between the filamentary element and the outer
edge of the barb.” Id. at 17; Reply Br. 2. Appellant submits that “the
Examiner’s gray line commences at the filamentary element, at a location
spaced away from the base of the barb, and thus does not extend along the
outer edge of the barb.” Reply Br. 2; see also id. at 2–3. Appellant contends
that when claim 1 is construed properly and applied to Nawrocki’s Figure 2,
the outer edge of Nawrocki’s barb “has a convex curved surface that extends
continuously between the base and the tip.” Appeal Br. 15. Appellant notes
correctly that Nawrocki “provides no written description regarding the shape
of the outer edge of the barb 204.” Id.
We are persuaded by Appellant’s argument. When claim 1 is read
onto Nawrocki’s suture, Nawrocki’s barb must have a base connected with a
filamentary element, wherein an outer edge of the barb faces away from the
filamentary element and extends between the base and tip of the barb, and
wherein the outer edge includes a first section having a concave surface.
The Examiner errs by relying on a section of Nawrocki’s filamentary
element in combination with the outer edge of Nawrocki’s barb 204 to
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define a concave surface, as depicted in Figure 2 of Narwrocki, rather than
an outer edge of Nawrocki’s barb 204 alone. .
Accordingly, we do not sustain the Examiner’s rejection of
independent claim 1, and claims 2–9 and 11–13. The Examiner relies on the
same findings relative to Nawrocki for similar limitations recited in
independent claims 15 and 20, and therefore, for essentially the same
reasons as set forth supra, we also do not sustain the Examiner’s rejection of
independent claims 15 and 20, and claim 21 depending therefrom. Final
Act. 9–10, 12.
Rejections II and III
The Examiner’s reliance on Bonutti for teaching limitations relative to
the claimed stop element, and also on Popadiuk for teaching the claimed
longitudinal tip-to-tip pitch defined by the barbs, do not cure the deficiency
in the Examiner’s finding relative to Nawrocki and as applied to independent
claims 1 and 15 supra, from which claims 14 and 16–19 depend.
Accordingly, we do not sustain the Examiner’s rejection of claims 14
and 16–19.

NEW GROUNDS OF REJECTION
Independent claim 1 and dependent claim 3
We determine that the error in the Examiner’s rejection discussed
supra is cured by the depiction, in Nawrocki’s Figure 6, of an outer edge of
a barb having a base connected with a filamentary element, wherein the
outer edge includes a first section having a concave surface that extends
between the base and a transition point of the barb, as required by
independent claim 1.
Figure 6 of Nawrocki is reproduced below.
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Nawrocki’s Figure 6 depicts an embodiment of a surgical suture that is
distinct from the embodiment depicted in Nawrocki’s Figure 2 and that
shows a concave surface extending between the base of first projection (or
barb) 601 and a transition point along the barb’s outer edge. Nawrocki
¶¶ 19, 21, 26.
Although patent drawings not indicated as drawn to scale should
generally not be relied on for dimensional measurements (see, e.g.,
Hockerson-Halberstadt, Inc. v. Avia Grp. Int’l, Inc., 222 F.3d 951, 956 (Fed.
Cir. 2000)), that does not mean “that things patent drawings show clearly are
to be disregarded” (In re Mraz, 455 F.2d 1069, 1072 (CCPA 1972)). Here,
a preponderance of the evidence supports a finding that Nawrocki’s Figure 6
clearly shows an outer edge of first projection (or barb) 601 including a first
section having a concave surface that extends between the barb’s base and a
transition point along the surface of the outer edge of the barb. Notably,
similar to the convex curved surface depicted on the leading (outer) edge 84
of Morency’s barb (for example, as depicted in Morency’s Figures 7A and
7B), Nawrocki also shows a second section having a convex curved surface
that extends from the transition point to a distal-most portion of the tip of
first projection (or barb) 601, as required by claim 1.
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For context, we reproduce below Figure 12B of the Specification,
which Appellant identifies as supporting the dual radius curve recited in
claim 1. See Appeal Br. 4–5 (“outer edge 234 . . . has a dual radius curve
including a first section 242 with a concave surface and a second section 244
with a convex surface,” and further, “transition point 246”).

Figure 12B of the Specification “shows a magnified view” of a filamentary
element having barbs. Spec. ¶ 43.
Similar to the transition point (i.e., transition point 246) identified in
Figure 12B of the Specification, we also find that because Nawrocki’s
Figure 6 depicts a concave surface that transitions into a convex curved
surface on the outer edge of first projection (or barb) 601, a transition point
as claimed is inherent (or necessarily present) on the surface of the outer
edge of Nawrocki’s barb. Further, we find that the limitation of claim 3,
which depends from independent claim 1, and recites in relevant part,
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“wherein said outer edge transforms from said concave surface of said first
section to said convex surface2 of said second section at said transition point
of said barb,” is also inherently disclosed in Nawrocki’s Figure 6 for the
same reason: a single surface that includes a concave curved surface (i.e., a
surface that curves inward like the interior of a circle) directly adjacent a
convex surface (i.e., a surface curved like the exterior of a circle) has at least
one point where the surface changes from defining convexity to defining
concavity. Appeal Br. 20 (Claims App.).
We reason that it would have been obvious to a person of ordinary
skill in the art, at the time the invention was made, to modify the single
radius curves on the leading (outer) edges 84 of Morency’s barbs 82, as
depicted in Morency’s Figures 7A and 7B, to be dual radius curves, as
taught by Nawrocki supra, by incorporating a concave surface at the base of
each of Morency’s barbs, directly adjacent the convex curved surfaces of
Morency’s barbs, as such a concave surface is taught by Nawrocki, or
alternatively, by substituting the entirety of Nawrocki’s dual radius outer
edge surface, which already has the claimed dual radius curve, for the
entirety of each of Morency’s single radius curve leading (outer) edges 84—
in each case, to yield the predictable result of providing a barbed suture
suitable for engaging tissue. Where “a patent claims a structure already
known in the prior art that is altered by the mere substitution of one element
for another known in the field, the combination must do more than yield a
predictable result.” In re Mouttet, 686 F.3d 1322, 1331 (Fed. Cir. 2012),
citing KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).

2 We construe the claim term “said convex surface” to refer back to “a
convex curved surface” recited in claim 1
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Thus, we apply our new findings and reasoning with respect to
Nawrocki in the rejection of independent claim 1 and dependent claim 3, as
discussed supra. Accordingly, we enter a NEW GROUND OF
REJECTION of independent claim 1, and dependent claim 3, under 35
U.S.C. § 103(a) as unpatentable over Morency and Nawrocki.
Dependent claim 2
Claim 2 depends from independent claim 1 and recites, in relevant
part,
wherein said tip of said barb has a convex curved radial surface
that extends from said convex surface3 of said outer edge of
said barb to said concave surface of said inner edge of said
barb, said convex curved radial surface of said tip having a
greater degree of curvature than the convex surface of said
outer edge of said barb.
Appeal Br. 20. The Examiner relies on Morency’s Figure 7B and
Nawrocki’s Figure 2 as depicting the claimed subject matter. Final Act. 4.
We find that Morency’s Figure 7B alone clearly shows that the convexity of
the tip of barb 82 has a greater degree of curvature than the convexity of
Morency’s convex curved section of leading (outer) edge 84. Morency ¶ 43,
Fig. 7B. Moreover, our proposed modification to Morency’s barb 82 (i.e., to
include a concave surface extending between the base and a transition point
as discussed supra) does not alter the degree of convexity of either the tip of
Morency’s barb 82, which is greater than the convex curved section of
Morency’s leading (outer) edge 84 as clearly shown in Morency’s Figure
7B—and which also would be greater than Nawrocki’s convex curved
section at reference numeral 601 as clearly shown in Nawrocki’s Figure 6.

3 We construe the claim term “said convex surface” to refer back to “a
convex curved surface” recited in claim 1.
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Thus, we apply the Examiner’s findings with respect to Morency’s
Figure 7B. However, because we rely on Figure 6 of Nawrocki, and not on
Figure 2 as relied on by the Examiner in the rejection of independent claim
1, we enter NEW GROUND OF REJECTION of claim 2 under 35 U.S.C.
§ 103(a) as unpatentable over Morency and Nawrocki.
Dependent claim 4
Claim 4 depends from independent claim 1 and recites, in relevant
part, “wherein said convex curved radial surface of said tip faces toward the
distal end of said filamentary element.” Appeal Br. 20 (Claims App.).
Notably, the Examiner relies correctly on Morency’s Figures 7A and 7B for
disclosing that the tip of each barb faces toward the distal end of the
filamentary element, as required by independent claim 1. Final Act. 3
(citing Morency, Figs.7A, 7B). In the same way, the convex curved radial
surface of Morency’s tip of each barb 82 faces toward the distal end of the
filamentary element, and such a configuration is not changed by our
proposed modification supra to Morency’s leading (outer) edge 84, in view
of Nawrocki.
Thus, we apply the Examiner’s findings with respect to Morency’s
Figures 7A and 7B. However, because we rely on Figure 6 of Nawrocki,
and not Figure 2 as relied on by the Examiner in the rejection of independent
claim 1, we enter NEW GROUND OF REJECTION of claim 4 under 35
U.S.C. § 103(a) as unpatentable over Morency and Nawrocki.
Dependent claims 5–9
Claims 5–9 depend from independent claim 1 and recite limitations
regarding the spacing (i.e., pitch) or relationship of barbs or pairs of barbs
along the length of the filamentary element. Appeal Br. 20–21 (Claims
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App.). In particular, (i) claim 5 depends from independent claim 1 and
recites, in relevant part “wherein said filamentary element has a length and
said barbs are evenly spaced along the length of said filamentary element”
(id. at 20); (ii) claim 6 depends from claim 5 and recites, in relevant part,
“wherein said tips of said evenly spaced barbs define a tip-to-tip pitch of
about 0.03-0.09 inches” (id.); (iii) claim 7 depends from claim 5 and recites,
in relevant part, “wherein said plurality of barbs includes pairs of barbs
evenly spaced along the length of said filamentary element, and wherein said
barbs in each pair are aligned with one another” (id. at 21); (iv) claim 8
depends from claim 7 and recites, in relevant part, “wherein said barbs in
each said pair project away from one another and are disposed on opposite
sides of said filamentary element” (id.); and (v) claim 9 depends from claim
8 and recites, in relevant part, “wherein said tips of said barbs in each said
pair define a lateral tip-to-tip distance of about 0.025-0.1 inches” (id.).
We apply the Examiner’s findings that Morency discloses the subject
matter of claims 5, 7, and 8. Final Act. 4–7. For example, Morency’s
Figure 7A clearly shows barbs 82 evenly spaced along the length of the
filamentary element, as required by claim 5, and further, Morency’s Figure
7A clearly shows barbs 82 in evenly spaced pairs, wherein each barb in the
pair is aligned with the other barb in the pair (i.e., vertically with respect to
the horizontal axis of the filamentary element as shown in Figure Morency’s
7A) and projecting away from and disposed on an opposite side of the
filamentary element with respect to the other barb in the pair, as required by
claims 7 and 8. See also, e.g., Morency ¶ 33 (“barbs 24 may be arranged in
opposing pairs”).
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Regarding the range of the tip-to-tip pitch recited in claim 6, Morency
discloses that the spacing of barbs 82 along the length of a barbed surgical
suture is a variable recognized in the prior art to affect gripping force: “[t]he
barbs may be closely spaced along the suture body for situations where a
high gripping force is needed or they may be spaced apart for situations
where a less griping force is needed.” Morency ¶ 37; cf. Spec. ¶ 58 (“[t]he
lateral tip-to-tip distance D2 preferably . . . enhances holding strength of the
wound closure device”). “[W]here the general conditions of a claim are
disclosed in the prior art, it is not inventive to discover the optimum or
workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456
(CCPA 1955). This rule is limited to cases in which the optimized variable
is a “result-effective variable.” In re Antonie, 559 F.2d 618, 620 (CCPA
1977). Here, we determine that the tip-to-tip pitch between barbs of a
barbed suture is a result-effective variable, and therefore, the optimal or
workable range recited in claim 6 is not patentable, because as a variable
recognized in the prior art to affect gripping force, the claimed range of tip-
to-tip pitch would be discoverable by routine experimentation.
Similarly, regarding the range of lateral tip-to-tip distance recited in
claim 9, Morency discloses that “[t]he barbs are of sufficient size . . . for
fastening the tissue and achieving closure of an incision or wound without
the need for tying knots in the suture,” such that Morency discloses that a
lateral tip-to-tip distance between opposing barbs of a barb pair, which is
dependent on the size of the opposing barbs, is a variable recognized in the
prior art to affect the ability to fasten the tissue to close a wound. Morency
¶ 8; cf. Spec. ¶ 3 (“[t]he size . . . of the barbs have practical limitations in a
surgical setting, and cannot simply be increased in size whenever increased
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holding strength is desired”). Here, we determine that the lateral tip-to-tip
distance between opposing pairs of barbs of a barbed suture is a result-
effective variable, and therefore, the optimal or workable range recited in
claim 9 is not patentable, because as a variable recognized in the prior art to
affect fastening of the tissue to close a wound, the claimed range of lateral
tip-to-tip distance would be discoverable by routine experimentation.
Further, we determine that as such sizing of barbs was known in the art, a
person of ordinary skill in the art, using common knowledge and common
sense, would appreciate the practical limitations in a surgical setting of
sizing barbs that are too large for the surgical application, as the
Specification cautions. See In re Sovish, 769 F.2d 738, 743 (Fed. Cir. 1985)
(skill is presumed on the part of one of ordinary skill in the art); In re Bozek,
416 F.2d 1385, 1390 (CCPA 1969).
Thus, we rely on Figure 6 of Nawrocki, and not Figure 2 as relied on
by the Examiner in the rejection of independent claim 1, and we apply the
Examiner’s findings with respect to Morency and also our additional
findings with respect to result-effective variables. Accordingly, we enter a
NEW GROUND OF REJECTION of claims 5–9 under 35 U.S.C. § 103(a)
as unpatentable over Morency and Nawrocki.
Dependent claim 11
Claim 11 depends from independent claim 1, and recites in relevant
part,
wherein said barb includes an interior curved surface defining a
second concave surface extending between said first concave
surface of said inner edge of said barb4 and said filamentary
element, said second concave surface of said interior curved

4 We construe the claim term “said first concave surface of said inner edge
of said barb” to refer back to “a concave surface” recited in claim 1.
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surface having a greater degree of curvature than said first
concave surface of said inner edge that extends continuously to
said tip of said barb.
Appeal Br. 21 (Claims App.). Cf. Spec., Fig. 12B (the convexity of the inner
edge at reference numeral 236 as compared to the convexity of the inner
edge at reference numeral 238).
The Examiner finds that Morency’s Figure 7A and Nawrocki’s Figure
2 disclose the second concave surface, as claimed. Final Act. 7. We find
that Nawrocki’s Figure 6 clearly shows an interior curved surface defining a
concave surface extending between a surface of the inner edge of barb 601
which extends to the tip and the filamentary surface. Further, we find that
such interior curved surface has a concavity with a small radius (or curved to
a great extent) as compared to, for example, the concavity of Morency’s
inner (trailing) edge 86 or the concavity of the inner edge of Nawrocki’s
barb that extends to the tip of the barb. Notably, Morency also teaches, with
reference to Figure 1D, that
[an] undercut trailing [(or inner)] edge help[s] to allow the
barbs to flex inward so that the barbed surgical suture moves
easily through the tissue in the forward direction, whereas when
there is tension on the barbed surgical suture in the reverse
direction the angled trailing edge helps to expand or flex the
barbs inward or outward, biting into and grasping the tissue to
resist rearward movement.
Morency ¶ 38.
We reason that it would have been obvious to a person of ordinary
skill in the art, at the time the invention was made, to further modify
Morency, by modifying Morency’s trailing (inner) edge 86, which as
depicted in Figure 7B clearly shows a (first) concave surface having a large
radius at reference numeral 86 (or curved to a small extent), as compared to
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Nawrocki’s interior curved and concave surface, to include an interior
curved surface defining a second concave surface at the base of Morency’s
barb 82, as taught in Nawrocki, as a simple substitution of one known inner
edge shape for another known inner edge shape to yield the predictable
result of providing a barbed surgical suture with improved flexibility for
moving the suture through tissue in one direction and for grasping the tissue
when the suture is moved through tissue in the reverse direction, as taught in
Morency.
Thus, we rely on Figure 6 of Nawrocki, and not Figure 2 as relied on
by the Examiner in the rejection of independent claim 1, and we rely on our
findings and reasoning as set forth supra. Accordingly, we enter NEW
GROUND OF REJECTION of claim 11 under 35 U.S.C. § 103(a) as
unpatentable over Morency and Nawrocki.
Dependent claim 12
Claim 12 depends from independent claim 1 and recites, in relevant
part, “wherein at least one of said barbs extends along a longitudinal axis
that defines an acute angle with the longitudinal axis of said filamentary
element of about 5-60º.” Appeal Br. 22 (Claims App.). We rely on the
Examiner’s finding that “Morency teaches the barbs diverge from centerline
at an acute angle less than 45º.” Final Act. 7 (citing Morency ¶ 38); see
Morency ¶ 38 (“[t]he leading edge of each barb diverges from the centerline
of the suture body at an acute angle, more preferably at an angle equal to or
less than 45.degree”); see also id., Fig. 1D (illustrated angle).
Accordingly, we rely on Figure 6 of Nawrocki, and not Figure 2 as
relied on by the Examiner in the rejection of independent claim 1, and we
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enter NEW GROUND OF REJECTION of claim 12 under 35 U.S.C.
§ 103(a) as unpatentable over Morency and Nawrocki.
Dependent claim 13
Claim 13 depends from independent claim 1 and recites, in relevant
part, “wherein said bases of said barbs are thicker than said tips of said
barbs, and wherein each said barb tapers inwardly between said base and
said tip at an angle of about 1-20º”. Appeal Br. 22 (Claims App.). The
Examiner finds that “Morency teaches the barbs diverge from centerline at
an acute angle less than 45º,” wherein “the angle is defined as being from
the tip of the barb to the base of the suture thus defining an inward taper.”
Final Act. 7–8 (citing Morency ¶ 38, Figs. 7A, 7B). However, we find that
although this passage from Morency supports the Examiner’s rejection of
claim 12 supra, the Examiner misinterprets this angle, as disclosed in
Morency, as applying to a taper angle with respect to a thicker base of a barb
relative to a tip of a barb.
Notwithstanding, Figure 1E of Morency depicts tapered barbs,
wherein the base of the barbs are thicker than the tips of the barbs, such that
each barb tapers inwardly between the base and the tip, as claimed. See
Morency ¶¶ 16, 35, Figs. 1C, 1E; cf. Spec. ¶ 65, Fig. 14 (angle a2).
Although the taper angle depicted in Morency’s Figure 1E appears to be
about 20º, as claimed, we decline to rely on this dimensional measurement
because Morency does not indicate Figure 1E is drawn to scale. Instead, we
rely on Morency’s disclosure that, specifically with respect to barb 42,
which features the tapered shape, “[t]he barbs . . . 42 . . . are configured to
allow the barbed surgical suture . . . to move through the tissue in one
direction and to resist moving through the tissue in the other direction” and
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that “[t]he barbs [(including tapered barb 42)] are of sufficient size and
appropriate geometry for fastening the tissue and achieving closure of an
incision or wound without the need for tying knots in the suture.” Morency
¶ 35, 37. Here, we determine that the angle of the taper that defines the
thickness of the suture body to a point at the tip of a barb is a result-effective
variable, and therefore, the optimal or workable range recited in claim 13 is
not patentable, because as a variable recognized in the prior art to affect the
movement and the fastening ability of the barbs within the tissue, the
claimed range of taper angle would be discoverable by routine
experimentation.
Accordingly, we rely on Figure 6 of Nawrocki, and not Figure 2 as
relied on by the Examiner in the rejection of independent claim 1, and our
findings and reasoning as set forth supra. Accordingly, we enter NEW
GROUND OF REJECTION of claim 13 under 35 U.S.C. § 103(a) as
unpatentable over Morency and Nawrocki.
Dependent claim 14
Claim 14 depends from independent claim 1 and requires, in relevant
part, that
said stop element ha[s] a total surface area, and a leading edge
area defined by a thickness and a width, the leading area
extending substantially perpendicular to the longitudinal axis of
said filamentary element, wherein the ratio of the leading edge
area to the total surface area is less than 10%.
Appeal Br. 22 (Claims App.). The Examiner finds that although Morency
discloses a stop element with a total surface area, and also a leading edge
defined by a thickness and a width, wherein the leading edge extends
substantially perpendicularly to the longitudinal axis of the filamentary
element, Morency fails to disclose the claimed range of the ratio of the
Appeal 2020-000593
Application 13/621,625
19
leading edge area to the total surface area of the stop element of less than
10%, as required by claim 14. Final Act. 13 (citing Morency ¶¶ 9, Fig. 8A).
The Examiner relies Bonutti for disclosing “a known suturing device
with a stop member,” and that “the portion of stop element (10) is connected
to a distal end of filamentary element (50), . . . where stop element (10) stops
the suture to which it is attached from backing out of an opening.” Final
Act. 13–14 (citing Bonutti 3:43–53; Figs. 4). The Examiner also finds that
Bonutti teaches a stop element, a hollow tubular member,
comprising: a length of 4mm, a diameter of 1 mm and a central
diameter of 0.5mm. The ratio of the area of the leading edge to
the total surface area is less than both 10% and 5%. . . . the
leading edge is defined by the end of the hollow tube and the
total surface area is defined by the total surface area of the
hollow tube.
Final Act. 14 (citing Bonutti 3:43–53). The Examiner reasons that it would
have been obvious “to substitute the stop element (27) of Morency with the
stop element (10) of Bonutti as Bonutti teaches a stop element which due to
its length being greater than its width, when rotated it does not accidentally
back out of an opening through which it is inserted.” Id. (citing Bonutti
3:43–53).
Indeed, Bonutti discloses, with reference to Figure 1, that
[suture] anchor 10 is longer than it is wide. That is, the length
of the anchor 10, between its distal end face 42 and its proximal
end face 36, is greater than the outer diameter of the anchor10.
The anchor 10 must be long enough, relative to its width, so
that when rotated it does not accidentally back out of an
opening through which it is inserted into body tissue such as
bone. More specifically, the anchor must be longer than the
diameter of the opening through which it is inserted into body
tissue such as bone. However, the anchor 10 should not be
longer than necessary, so as to avoid unnecessary tissue
damage.
Appeal 2020-000593
Application 13/621,625
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Bonutti 3:43–53. In particular, Bonutti discloses that a cylindrical stop
element or suture anchor, wherein “a suitable range of dimensions is from
about length equals 1.5 times width to about length equals four times width.
It is preferred that the length to width ratio be about three to two for an
anchor in bone, and longer (possibly four to one) for a soft tissue anchor.”
Bonutti 3:54–58.
Thus, for a cylindrical stop element having a height (or length) of 4
mm and a circular end surface (or leading edge) having a radius of 0.5 mm,
the leading edge area is solved by the equation:
A = п r2
3.14 x (0.5)2 = 0.785;
and the total surface area of the cylinder is solved by the equation:
2 п r h + 2 п r2
(2 x 3.14 x 0.5 x 4) + (2 x 3.14 x (0.5)2) = 14.14;
resulting in a ratio defined by the equation:
0.785 ÷ 14.14 = 0.055;
or a ratio of about 5% (recognizing that there is also central channel through
the center of the cylinder for receiving the suture, which is not factored into
these calculations). In other words, we rely on the Examiner’s finding that
Bonutti discloses a ratio of the leading edge area of a stop element to the
total surface area the stop element of less than 10%, as required by claim 14,
and the Examiner’s reasoning in the proposed modification of Morency’s
stop element supra.
Alternatively, the passages from Bonutti supra evidence that the ratio
of leading edge area of a stop element to the total surface area of the stop
element is a variable recognized in the prior art to affect the ability to anchor
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21
the stop element within tissue when inserted through an incision or into a
bone. In other words, we determine that ratio of the leading edge area to the
total surface area of a stop element on a suture is a result-effective variable,
and therefore, the optimal or workable range recited in claim 14 is not
patentable, because as a variable recognized in the prior art to affect the
ability of the stop element to remain in the tissue, the claimed ratio would be
discoverable by routine experimentation.
Thus, we rely on Figure 6 of Nawrocki, and not Figure 2 as relied on
by the Examiner in the rejection of independent claim 1, and also the
Examiner’s findings and, alternatively, our own. Accordingly, we enter
NEW GROUND OF REJECTION of claim 14 under 35 U.S.C. § 103(a) as
unpatentable over Morency, Nawrocki, and Bonutti.
Independent claim 15
Independent claim 15 recites the same limitations as recited in
independent claim 1 supra, except that claim 15 also incorporates the
limitations of claims 2, 4, and 11 discussed supra. Appeal Br. 22–23
(Claims App.). In addition, claim 15 recites, in relevant part, “wherein said
inner edge of said barb has said first concave surface that extends along the
majority of the length of said inner edge.” Id. We find that Nawrocki’s
Figure 6 clearly shows the interior curved surface having the second concave
surface as predominately at the base of barb 601, such that the majority of
the leading (outer) edge of Nawrocki’s barb is a different surface, or a
different convex surface (i.e., a first concave surface), which extends the
majority of length of the inner edge of the barb. Thus, when modifying
Morency’s trailing (inner) edge 86 to include Nawrocki’s interior curved
surface having the second concave surface, for example, to provide the
Appeal 2020-000593
Application 13/621,625
22
advantageous undercut as discussed supra with respect to claim 11, we
reason that it would have been obvious to one of ordinary skill in the art to
incorporate Nawrocki’s interior curved surface having the second concave
predominately at the base of Morency’s barb 82, such that Morency’s first
concave surface at 86 extends along the majority of Morency’s inner edge.
Thus, we apply our findings and reasoning as set forth supra with
respect to independent claim 1, and dependent claims 2, 4, and 11, as well as
our new findings relative to limitation discussed supra. Accordingly, we
enter a NEW GROUND OF REJECTION of claim 15 under 35 U.S.C.
§ 103(a) as unpatentable over Morency and Nawrocki.
Dependent claim 16
Claim 16 depends from independent claim 15 and recites, in relevant
part, the limitations of claims 2 and 5–9 as discussed supra. Appeal Br. 24
(Claims App.). Thus, we apply our findings and reasoning as set forth supra
with respect to independent claims 1 and 15, and dependent claims 2 and 5–
9. Accordingly, we enter a NEW GROUND OF REJECTION of claim 16
under 35 U.S.C. § 103(a) as unpatentable over Morency and Nawrocki.
Dependent claims 17–19
Claims 17–19 depend from independent claim 15 and recite, in
relevant part, the limitations of claim 14 discussed supra (claim 17), and
also a ratio of the leading edge area of the stop element to the total surface
area of the stop element less than 5% (claim 18), and further, specific width,
length, and thickness dimensions of the stop element (claim 19). Appeal Br.
24 (Claims App.). We apply our findings and reasoning as set forth supra
with respect to independent claim 1, and dependent claim 14, and our
findings that the variables recited in claims 17–19 are result-effective
Appeal 2020-000593
Application 13/621,625
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variables. Therefore, the optimal or workable ranges of the stop element
variables recited in claims 17–19 are not patentable, because as variables
recognized in the prior art to affect the ability of the stop element to remain
in the tissue, the claimed ranges would be discoverable by routine
experimentation.
Accordingly, we enter a NEW GROUND OF REJECTION of claims
17–19 under 35 U.S.C. § 103(a) as unpatentable over Morency, Nawrocki,
and Bonutti.
Independent claim 20
Independent claim 20 recites the same limitations as recited in
independent claim 1 supra, except that claim 20 also incorporates the
limitations of claims 2 and 11 discussed supra. Appeal Br. 22–23 (Claims
App.). We apply our findings and reasoning as set forth supra with respect
to independent claim 1, and dependent claims 2 and 11. Accordingly, we
enter a NEW GROUND OF REJECTION of claim 20 under 35 U.S.C.
§ 103(a) as unpatentable over Morency and Nawrocki.
Dependent claim 21
Similar to the additional limitation recited in independent claim 15
discussed supra, claim 21, which depends from independent claim 20,
recites, in relevant part, “wherein said concave surface of said inner edge of
said barb extends along the majority of the length of said inner edge between
said base and said tip of said barb.” Appeal Br. 26. We apply our findings
and reasoning as set forth supra with respect to independent claims 1 and 15,
and dependent claims 2 and 11. Accordingly, we enter a NEW GROUND
OF REJECTION of claim 21 under 35 U.S.C. § 103(a) as unpatentable over
Morency and Nawrocki.
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Application 13/621,625
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CONCLUSION
In summary:
Claims
Rejected
35
U.S.C.
§
Reference(s) Affirmed Reversed New
Ground
of
Rejection
1–9, 11–
13, 15, 20,
21
103(a) Morency,
Nawrocki
1–9, 11–
13, 15, 20,
21
1–9, 11–
13, 15,
16, 20, 21
14, 17–19 103(a) Morency,
Nawrocki,
Bonutti
14, 17–19 14, 17–19
16 103(a) Morency,
Nawrocki,
Popadiuk
16
Overall
Outcome
1–9, 11–
21
1–9, 11–
21

TIME PERIOD FOR RESPONSE
This decision contains a new ground of rejection pursuant to
37 C.F.R. § 41.50(b). 37 C.F.R. § 41.50(b) provides “[a] new ground of
rejection pursuant to this paragraph shall not be considered final for judicial
review.”
37 C.F.R. § 41.50(b) also provides that the Appellant, WITHIN TWO
MONTHS FROM THE DATE OF THE DECISION, must exercise one of
the following two options with respect to the new ground of rejection to
avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new Evidence relating
to the claims so rejected, or both, and have the matter
reconsidered by the examiner, in which event the prosecution
will be remanded to the examiner. . . .
Appeal 2020-000593
Application 13/621,625
25
(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same Record. . . .

Further guidance on responding to a new ground of rejection can be
found in the Manual of Patent Examining Procedure § 1214.01.
REVERSED; 37 C.F.R. 41.50(b)