Ex Parte Gross et al

Patent Trial and Appeal Board

Dec 21, 2018

13429150 (P.T.A.B. Dec. 21, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/429, 150 03/23/2012
135715 7590
EthiconLLC
c/o Frost Brown Todd LLC
3300 Great American Tower
301 East Fourth Street
Cincinnati, OH 45202
12/26/2018
FIRST NAMED INVENTOR
Jeffrey M. Gross
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
ETH5714USNP.065191 l 2091
EXAMINER
HOUSTON, ELIZABETH
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
12/26/2018 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
patents@fbtlaw.com
lgroves@fbtlaw.com
jdewar@fbtlaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JEFFREY M. GROSS, LEV DRUBETSKY,
WILLIAM L. D'AGOSTINO, and WILLIAM L. HUNTER 1
Appeal 2017-011253
Application 13/429, 150
Technology Center 3700
Before RICHARD M. LEBOVITZ, TA WEN CHANG, and TIMOTHY G.
MAJORS, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims directed to a self-retaining suture and a
method of suturing using a self-retaining suture system. The Examiner
rejected the claims as obvious under 35 U.S.C. § 103. Pursuant to 35 U.S.C.
§ 134, Appellants appeal the Examiner's determination that the claims are
unpatentable. We have jurisdiction under 35 U.S.C. § 6(b ). The rejections
are affirmed.
1 The Appeal Brief ("Br."; entered Feb. 1, 2016) 1 identifies Ethicon, Inc. as
the real party in interest.
Appeal 2017-011253
Application 13/429,150
STATEMENT OF THE CASE
Claims 1-12, 22, 24, and 25 stand rejected by the Examiner as
follows:
1. Claims 1-3, 5, 7, 8, 22, 24 and 25 under pre-AIA 35 U.S.C.
§ I03(a) as obvious over the combination of Maiorino (U.S. Patent Pub.
2010/0063540 Al, published Mar. 11, 2010) and Wilk et al. (U.S. Patent
No. 5,123,913, issued Jun. 23, 1992) ("Wilk"). Final Act. 2.
2. Claim 4 under pre-AIA 35 U.S.C. § I03(a) as obvious over the
combination of Maiorino, Wilk, and Cohen et al. (U.S. Patent
Pub. 2009/0210006 Al, published Aug. 20, 2009) ("Cohen"). Final Act. 5.
3. Claim 6 under pre-AIA 35 U.S.C. § I03(a) as obvious over the
combination of Maiorino, Wilk, and Machold et al. (U.S. Patent Pub.
2006/0106278 Al, published May 18, 2006) ("Machold"). Final Act. 6.
4. Claims 9-12 under pre-AIA 35 U.S.C. § I03(a) as obvious over
the combination of Maiorino, Wilk, and Ochiai (U.S. Patent Pub.
2009/0318958 Al, published Dec. 24, 2009). Final Act. 7.
OBVIOUSNESS REJECTION BASED ON MAIORINO AND WILK
Independent claim 1 is reproduced below:
1. A self-retaining suture comprising:
a. a first end for penetrating tissue;
b. an elongated suture body having a periphery;
c. a first plurality of retainers on the periphery of the
elongated body and oriented to the first end, the first plurality
of retainers yielding toward the suture body during movement
of the suture through tissue in a direction of deployment of the
first end, and resisting movement of the suture, when in tissue,
in a direction substantially opposite the direction of deployment
of the first end;
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Application 13/429,150
d. a second end having a variable loop of variable
circumference, wherein the variable loop includes a fixed loop
slidably engaging the elongated body for slidingly varying the
circumference of the variable loop, where the fixed loop has no
retainers on its surface and said fixed loop is formed by passing
a non-deployment terminus of the suture body around and back
upon itself and attaching said non-deployment terminus to the
suture body such that said non-deployment terminus is located
outside the interior of the fixed loop, and wherein the first end
may pass through the variable loop to secure tissue as an
anchor, the anchor preventing movement of the suture in the
direction of deployment of the first end.
Claims 2, 3, 5, 7, 8, 22, 24 and 25 depend from claim 1. These claims
were not argued separately and therefore fall with claim 1.
We begin with claim 1. Fig. IA of the Specification, reproduced
below, shows a self-retaining suture within the scope of the claims. The
figure is annotated to identify specific parts of the suture recited in claim 1.
lll·i···---- Fig. JA
Fig. IA of the Specification, reproduced above, shows an embodiment
of the claimed "self-retaining suture", labeled as 100 with an elongated
suture body. Feature 101 is the "a. first end for penetrating tissue" of claim
1. The "plurality of retainers" of "c" of claim 1 are shown in Fig. 1 A as
structures 104. The figure shows the second end "d" of claim 1 having the
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Appeal 2017-011253
Application 13/429,150
claimed fixed and variable loops. The "variable loop" is labeled as 108.
Variable loop 108 has a "fixed loop" 112 which is recited in "d" of the claim
to be for "slidably engaging the elongated body for slidingly varying the
circumference of the variable loop."
The Examiner found that Maiorino describes a suture comprising a
first end a for penetrating tissue, an elongated suture body b, and a second
end d having a fixed loop and variable loop as claimed. Final Act. 2-3. The
Examiner found that Maiorino does not describe its suture as having a
plurality of retainers oriented and configured as inc of claim 1. Id. at 3.
However, the Examiner found that Wilk describes a suture with such a
configuration and that it would have been obvious to one of ordinary skill in
the art to have modified Maiorino with Wilk' s retainers "to provide a
smooth or streamlined configuration to body tissues through which the
suture is being pulled during a stitching or sewing stroke and to expand into
an opened configuration upon a pulling of the suture in a reverse direction
after a sewing operation has been completed such that it acts as a self-
locking feature of the suture." Id. at 4.
Appellants contend that "Maiorino' s disclosure not only fails to teach
the claimed subject matter, but teaches a different use of its device." Br. 5.
Appellants discuss how Maiorino' s suture is used differently from the suture
of claim 1. Id. at 6-7.
This argument is not persuasive because independent claim 1 is
directed to the suture, itself, and not how it is used. 2 Accordingly, the
2
"[ A Jpparatus claims cover what a device is, not what a device does"
Hewlett-Packard Co .v. Bausch & Lomb Inc., 909 F.2d 1464, 1469 (Fed.
Cir. 1990).
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Appeal 2017-011253
Application 13/429,150
argument is unavailing because it does not distinguish the claimed suture on
the basis of its structure.
Appellants further argue that "the size of the loop is quite small" in
Maiorino, "which requires the clinician to make effort in finding the loop
and running the deployment end of the suture through it." Br. 6. This
argument does not persuade us that the Examiner erred. Claim 1 is not
limited to a specifically sized fixed loop. Thus, Appellants are arguing a
structural limitation that does not appear in the claims. In addition, as
discussed by the Examiner, Maiorino teaches that "loop 12 is sized to
receive proximal end 10a of looped suture 10." Ans. 2-3 (citing paragraph
25 of Maiorino ). Appellants' arguments did not address this explicit
disclosure in Maiorino about the loop being sized to receive the end of the
suture, the same configuration as claimed.
Appellants also argue that when the fixed loop is welded or otherwise
attached to the suture body, it is subject to drag and potential breakage
unless used in the way described by the "present invention." Br. 6-7. This
argument does not demonstrate error in the rejection. Appellants have not
distinguished the structure of the claimed suture from Maiorino, but rather
make an argument based on its intended use. If a prior art structure is
capable of performing the intended use as recited in the preamble, then it
meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir.
1997). While features of an apparatus may be recited either structurally or
functionally, claims directed to an apparatus must be distinguished from the
prior art in terms of structure rather than function. Id. at 1477-78.
Appellants have not done so here.
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Application 13/429,150
For the foregoing reasons, the obviousness rejection of claim 1 is
affirmed. Dependent claims 2, 3, 5, 7, 8, 22, 24 and 25 were not argued
separately and therefore fall with claim 1. 37 C.F.R. § 4I.37(c)(l)(iv).
REJECTION BASED ON MAIORINO, WILK, AND COHEN
Claim 4, depends from claim 1, and further recites: "the elongated
body has a cross section having a transverse length (tl) and the fixed loop
has an inner transverse length (TL) and wherein the ratio of TL:tl is about
1: 1 to about 10: 1."
The Examiner found that Cohen describes a suture having an
elongated body and loop and that the ratio between them may be configured
and dimensioned to be adjustable. Final Act. 5. The Examiner found it
obvious to have made the modification to the suture based on the
combination of Maiorino and Wilk. Id. at 5---6. Appellants rely on the same
unpersuasive arguments as for claim 1. Br. 8. Consequently, the rejection
of claim 4 is affirmed for the same reasons as for claim 1.
REJECTION BASED ON MAIORINO, WILK, AND MACHOLD
Claim 6, depends from claim 1, and further recites that the fixed loop
"comprises a visible marking." The Examiner found that Machold describes
a suture with a visible marking to facilitate grasping it. Final Act. 6.
Appellants rely on the same unpersuasive arguments as for the combination
of Maiorino and Wilk. Br. 8. Consequently, the rejection of claim 6 is
affirmed for the same reasons as for claim 1.
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REJECTION BASED ON MAIORINO, WILK, AND OCHIAI
Independent claim 9 is reproduced below:
9. A method of suturing comprising:
a. providing a self-retaining system comprising a suture
needle attached to an end of a self-retaining suture, the self-
retaining suture comprising a suture thread having a thread
diameter, a plurality of tissue retainers and an eyelet, said eyelet
formed by passing a non-deployment terminus of the suture
thread around and back upon itself and attaching said non-
deployment terminus to the suture thread such that said
nondeployment terminus is located outside the interior of the
eyelet, where the suture thread passes through the eyelet to
form a variable loop having an original diameter;
b. inserting the needle into the tissue of a patient at a first
tissue location;
c. withdrawing the needle from the tissue of the patient at
a second tissue location;
d. passing the needle and at least some of the suture
thread through the variable loop;
e. inserting the needle into the tissue of the patient at a
third tissue location.
The Examiner found that Maiorino describes a suture as recited in a of
claim 9 comprising an eyelet (fixed loop or eyelet 112 as shown in Fig. IA
of the Specification reproduced above) and a suture thread passing through
the eyelet to form a variable loop (variable loop 108 as shown in Fig. IA of
the Specification reproduced above). Final Act. 7. The Examiner further
found that Maiorino describes "inserting the needle into the tissue of a
patient at a first tissue location" as in b of claim 9, but acknowledged that
Maiorino does not describe steps c, d, and e of claim 9. Id. To meet this
deficiency, the Examiner relied upon the teachings in Wilk for steps c and d,
and Ochiai for step e. Id. at 7-8.
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Application 13/429,150
Appellants state that in Maiorino the fixed loop serves as the anchor
and that once the loop is received into the tissue, "only then is the proximal
end of suture inserted through the loop" to form the variable loop which is
then knotted to secure the suture. Br. 5---6. In contrast, Appellants argue that
the claimed suture "is provided with the suture inserted through a fixed loop
initially, forming a variable loop configuration. It is this variable loop
configuration that forms the anchor." Br. 6 ( emphasis added). Appellants
explain that after the suture with the variable loop is inserted into the tissue,
the proximal end of the suture is inserted through the variable loop and "with
continued pulling or force or tension, the circumference of the variable loop
will tend to decrease, until ... the variable loop has a desired circumference,
at which time the clinician will stop pulling on the deployment end and the
anchor is thus formed." Id. Appellants further argue that the use of the
variable loop as the anchoring structure is advantageous because the force
exerted on the anchor is distributed over a broader structure. Id. at 7.
Appellants' arguments do not persuade us that the Examiner erred.
Appellants' arguments regarding the advantages of the variable loop as an
anchoring structure, in contrast to the teachings in Maiorino, ignores the
Examiner's explicit reliance on Wilk for steps c and d of claim 9.
Specifically, the Examiner cited Figure 9B of Wilk as showing a suture with
a variable loop. Final Act. 7-8. The Examiner further found that Figure 9C
of Wilk shows passing a needle, with thread attached to it, through the
variable loop as in step d of claim 9. Id. Figures 9B and 9C of Wilk are
reproduced below.
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Application 13/429,150
FIG-98
F/G-9C
524
530
514
Figure 9B of Wilk shows the suture with a bore 516 which
corresponds to the claimed "eyelet" or fixed loop, and loop 524 which
corresponds to the claimed "variable loop." Wilk 9:28--40. Figure 9C of
Wilk shows the end of thread 526 threaded through the loop 524. Id.
The Examiner cited the following disclosure from Wilk to further to
further support these findings:
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Application 13/429,150
The use of suture device 510 to close an open cut 42 is
schematically depicted in FIGS. 9A through 9D. Upon a
placement of device 510 proximately to body tissues 40 near
cut 42, as illustrated in FIG. 9A, the free end of thread 526 is
passed through tissues 40, cut 42 and tissues 44 on the other
side of the cut [compare band c of claim 9] .... As shown in
FIG. 9B, needle extension 532 is removed or cut from thread
526 upon the passage of the thread through tissue portion 44.
Subsequently, the free end of thread 526 is passed through loop
524, as shown in FIG. 9C [ compare step d of claim 9].
Wilk 9:28-33, 36-40.
Thus, the Examiner's findings are fully supported by the figures and
accompanying disclosure in Wilk. Appellants argued Maiorino separately
without addressing the disclosure in Wilk that the Examiner relies upon to
meet steps c and d of claim 9. "Non-obviousness cannot be established by
attacking references individually where the rejection is based upon the
teachings of a combination of references." In re Merck & Co., 800 F.2d
1091, 1097 (Fed. Cir. 1986).
For the foregoing reasons, the obviousness rejection of claim 9 is
affirmed. Dependent claims 10-12 were not argued separately and therefore
fall with claim 9. 37 C.F.R. § 4I.37(c)(l)(iv).
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Application 13/429,150
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)(l )(iv).
AFFIRMED
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