Ex Parte Criscuolo et al

Patent Trial and Appeal Board

Feb 4, 2016

12943107 (P.T.A.B. Feb. 4, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/943,107 11/10/2010
50855 7590 02/08/2016
Covidien LP
555 Long Wharf Drive
Mail Stop SN-I, Legal Department
New Haven, CT 06511
FIRST NAMED INVENTOR
Christopher J. Criscuolo
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.
H-US-01566 (203-6860) 3032
EXAMINER
ORKIN, ALEXANDER J
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
02/08/2016 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):
mail@cdfslaw.com
SurgicalUS@covidien.com
medtronic_mitg-si_docketing@cardinal-ip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CHRISTOPHER J. CRISCUOLO, JONATHAN GLICK,
TIMOTHY D. KOSA, MICHAEL PRIMA VERA, and KEVIN SLISZ
Appeal2014-001648
Application 12/943, 107
Technology Center 3700
Before JAMES P. CAL VE, GEORGE R. HOSKINS, and
FREDERICK C. LANEY, Administrative Patent Judges.
HOSKINS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Christopher J. Criscuolo et al. ("Appellants") 1 appeal under 35 U.S.C.
§ 134 from the Examiner's decision rejecting claims 1-8, 15-22, 28, and 29
in this application. The Board has jurisdiction over the appeal under 3 5
U.S.C. § 6(b).
We AFFIRM-IN-PART.
1 The Appeal Brief identifies Covidien LP as the real party in interest.
Appeal Br. 1.
Appeal2014-001648
Application 12/943, 107
CLAIMED SUBJECT MATTER
Claims 1, 15, and 29 are independent. Claim 1 illustrates the subject
matter on appeal:
1. A method of laparoscopic repair of a ventral hernia,
comprising the steps of:
a. providing a needle;
b. providing a barbed suture having a distal end attached to
said needle;
c. providing a surgical mesh;
d. rolling said surgical mesh, said barbed suture, and said
needle to form a rolled mesh having said needle positioned
within a perimeter of said rolled mesh and oriented
substantially parallel to a longitudinal axis of said rolled mesh;
e. transferring said rolled mesh into a body cavity via a
laparoscopic device;
f. unrolling and laying said surgical mesh under a ventral
hernia in an abdominal wall;
g. threading said needle and barbed suture through said
surgical mesh and said abdominal wall; and
h. trimming said barbed suture.
Appeal Br. 26 (Claims App.).
REJECTIONS ON APPEAL
Claims 1-3, 5-8, 28, and 29 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Leung (US 2009/0228021 Al, pub. Sept. 10, 2009) and
St-Germain (US 2008/0167519 Al, pub. July 10, 2008).
Claim 4 is rejected under 35 U.S.C. § 103(a) as unpatentable over
Leung, St-Germain, and Eldar (US 2008/0195121 Al, pub. Aug. 14, 2008).
Claims 15-22 are rejected under 35 U.S.C. § 103(a) as unpatentable
over Leung and Eldar.
2
Appeal2014-001648
Application 12/943, 107
ANALYSIS
A. Obviousness based on Leung and St-Germain
(claims 1-3, 5-8, 28, and 29)
In rejecting claim 1 as unpatentable over Leung and St-Germain, the
Examiner finds Leung discloses the claimed steps of providing a needle 56,
providing a barbed suture 46 attached to the needle, and threading the needle
and suture through a surgical mesh 32 and an abdominal wall. Final Act. 2-
3; see Leung, Fig. 1. The Examiner further finds Leung "is silent about the
specific rolling the mesh, suture, and needle into a laparoscopic device step."
Final Act. 3. The Examiner cites St-Germain as disclosing a hernia repair
using a mesh and suture, including rolling the mesh and suture to transfer the
rolled combination into a body cavity via a laparoscopic device. Id.; see
St-Germain, Fig. 5, i-fi-133, 38. The Examiner determines it would have been
obvious to use the rolling method and laparoscopic device of St-Germain
with the method of Leung to facilitate insertion of Leung's mesh 32 into the
body in proximity to a hernia. Final Act. 3.
Further according to the Examiner, Figures 1 and 3 of Leung show
needles 56 and sutures 46 "extending parallel and perpendicular to"
mesh 32, and Figure 5 of St-Germain similarly shows sutures 18 "at parallel
and perpendicular arrangements." Adv. Act. 2. "Therefore, ifthe
mesh/sutures/needles of Leung were rolled like St-Germain, some of the
needles/sutures would be parallel to the longitudinal axis" as required by
claim 1. Id. (emphasis added). The Examiner moreover determines:
[I]t is known, and would be common sense, to have the needle
be parallel, or even substantially parallel, to the longitudinal
axis as it is rolled up, because if it is not parallel, the length of
the needle would be larger than the width of the rolled up
3
Appeal2014-001648
Application 12/943, 107
device which would create having to use a larger incision, and
potential harm to the user and patient.
Ans. 4--5.
We agree with Appellants that neither Leung nor St-Germain teaches
a rolled mesh having a needle "oriented substantially parallel to a
longitudinal axis of' the mesh, as recited in claim 1. Appeal Br. 14--18;
Reply Br. 6. Leung discloses mesh 32 having some barbed sutures ending at
a "point" 56, and other barbed sutures ending at a "surgical needle" 54.
Leung, Fig. 1, i-fi-137-38. Even assuming the Examiner is correct in finding
that Leung discloses a "rolled mesh" (Final Act. 2-3 (citing Leung i-fi-143,
52)), a preponderance of the evidence does not indicate that Leung's needles
are substantially parallel to the longitudinal axis of the rolled mesh. The
Examiner's citation to Leung's Figures 1 and 3 as showing needles 56
extending parallel and perpendicular to mesh 32 (Adv. Act. 2) is not
probative of how needles 56 would be configured in a rolled configuration
of mesh 32.
As to St-Germain, a preponderance of the evidence supports the
Examiner's finding that the rolled configuration 40 of Figure 5 shows
sutures 18 at parallel and perpendicular arrangements with respect to the
longitudinal axis of the roll. Adv. Act. 2. However, this is inapposite to the
claim language, which requires the needles to be oriented substantially
parallel to the longitudinal axis. St-Germain does not rely on needles to
insert sutures 18 through tissue. See St-Germain, i-fi-1 4, 33-34. Thus,
St-Germain does not disclose a needle being oriented substantially parallel
to the longitudinal axis of its rolled mesh.
4
Appeal2014-001648
Application 12/943, 107
Therefore, the rejection can be affirmed, if at all, only on the
Examiner's determination that it would have been common sense to have a
needle be substantially parallel to the longitudinal axis of the roll, "because
if it is not parallel, the length of the needle would be larger than the width of
the rolled up device which would create having to use a larger incision."
Ans. 4--5. The Examiner does not cite any support for this finding. See id.
We agree with Appellants that this determination is not supported by a
preponderance of the evidence. Reply Br. 7. In particular, the evidentiary
record before us fails to establish that the length of the needle necessarily is
larger than the interior diameter of the rolled mesh, or larger than the width
of the laparoscopic incision used to insert the rolled mesh and needle into a
patient. Thus, the Examiner's finding in this regard is speculative.
For the foregoing reasons, we determine the Examiner's rejection of
claim 1 is not supported by a preponderance of the evidence. The rejection
of independent claim 29 rests upon the same findings. Final Act. 2-3;
Ans. 4--5. The rejection of claims 2, 3, 5-8, and 28, which depend directly
or indirectly from claim 1, does not cure the deficiencies noted for claim 1.
Final Act. 2--4. Thus, we do not sustain the rejection of claims 1-3, 5-8, 28,
and 29 as unpatentable over Leung and St-Germain.
B. Obviousness based on Leung, St-Germain, and Eldar (claim 4)
The rejection of claim 4, which depends from claim 1, does not cure
the deficiencies of the Examiner's findings concerning the combination of
Leung and St-Germain noted above with respect to claim 1. Final Act. 4.
We, therefore, do not sustain the rejection of claim 4 as unpatentable over
Leung, St-Germain, and Eldar.
5
Appeal2014-001648
Application 12/943, 107
C. Obviousness based on Leung and Eldar (claims 15-22)
Appellants argue for the patentability of claims 15-22 together as a
group. Appeal Br. 21-23. We select claim 15 as the representative claim
for our decision. See 37 C.F.R. § 41.37(c)(l)(iv).
Appellants argue the Examiner errs because Leung and Eldar fail to
disclose attaching a needle to a barbed suture "after the mesh has been
transferred into a body cavity, unrolled, and laid under a hernia," as recited
in claim 15. Appeal Br. 22-23 (emphasis added).
The Examiner responds that "the sequential nature of steps of
claim 15" relied upon by Appellants is not claimed. Final Act. 6; Ans. 5.
We agree with the Examiner that the broadest reasonable interpretation of
claim 15 does not require the "attaching" step ( f) to occur after the
"transferring" step ( d), or after the "unrolling" and "laying" step ( e ), as
Appellants would have it. See In re Am. A cad. of Sci. Tech Ctr., 367 F .3d
1359, 1364 (Fed. Cir. 2004) (broadest reasonable interpretation applied
during patent prosecution); Mformation Techs., Inc. v. Research In Motion
Ltd., 764 F.3d 1392, 1398-99 (Fed. Cir. 2014) (claim requires an ordering of
steps when the claim language, as a matter of logic or grammar, requires that
the steps be performed in the order written, or the specification directly or
implicitly requires an order of steps); Baldwin Graphic Systems, Inc. v.
Siebert, Inc., 512 F.3d 1338, 1345 (Fed. Cir. 2008) ("[A]lthough a method
claim necessarily recites the steps of the method in a particular order, as a
general rule the claim is not limited to performance of the steps in the order
recited, unless the claim explicitly or implicitly requires a specific order.").
In the Reply Brief, Appellants do not provide persuasive argument for
interpreting claim 15 to require an order of steps. Rather, Appellants object
6
Appeal2014-001648
Application 12/943, 107
to the Examiner's refusal to enter a proposed amendment to claim 15,
submitted after the mailing of the Final Office Action presently on appeal,
which would have added "after unrolling the surgical mesh" to the end of
step (t). Reply Br. 8-9; see After-Final Amendment dated April 15, 2013, at
4 (proposed amendment). However, such refusals are subject to review via
petition to the Director, not appeal to the Board. See 37 C.F.R. § 1.127; In
re Berger, 279 F.3d 975, 984--85 (Fed. Cir. 2002). We therefore do not
review the refusal.
For the foregoing reasons, we sustain the rejection of claims 15-22 as
unpatentable over Leung and Eldar.
DECISION
The Examiner's rejection of claims 1-3, 5-8, 28, and 29 as
unpatentable over Leung and St-Germain is reversed.
The Examiner's rejection of claim 4 as unpatentable over Leung,
St-Germain, and Eldar is reversed.
The Examiner's rejection of claims 15-22 as unpatentable over Leung
and Eldar is affirmed.
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-IN-PART
7