Ex Parte Craig

Patent Trial and Appeal Board

Mar 6, 2018

14093705 (P.T.A.B. Mar. 6, 2018)

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
14/093,705 12/02/2013 JASON L.
50855 7590 03/08/2018
Covidien LP
60 Middletown Avenue
Mailstop 54, Legal Dept.
North Haven, CT 06473
INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
CRAIG H-US-02053DIV(203-7018) 3634
EXAMINER
RAM, JOCELYN D
ART UNIT PAPER NUMBER
3739
NOTIFICATION DATE DELIVERY MODE
03/08/2018 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):
SurgicalUS@covidien.com
medtronic_mitg-si_docketing@cardinal-ip.com
mail @ cdfslaw. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JASON L. CRAIG1
Appeal 2017-003362
Application 14/093,705
Technology Center 3700
Before DONALD E. ADAMS, ERIC B. GRIMES, and DAVID COTTA,
Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134 involving claims to a hernia
repair system, which have been rejected as obvious. We have jurisdiction
under 35 U.S.C. § 6(b).
We reverse.
STATEMENT OF THE CASE
“Hernias may be surgically repaired, and are principally repaired by
pushing back, or ‘reducing’, the herniated tissue. . . . Modem muscle
reinforcement techniques involve placement of an implant, such as a surgical
mesh, near the injured tissue or defect to support the defect.” (Spec. 13.)
1 Appellant identifies the Real Party in Interest as Covidien LP. (Appeal Br.
2.)
Appeal 2017-003362
Application 14/093,705
The Specification discloses using electrosurgical energy and pressure to seal
a surgical mesh to tissue at an underlying tissue site. {Id. 1 5.)
“[Ejmbodiments of surgical meshes . . . each include one or more
electrodes . . . embedded therein.” {Id. 158.) “After placement of one or
more of the surgical meshes . . . , an electrosurgical instrument. . .
selectively applies an effective amount of energy (and pressure in the case of
bipolar) to the respective electrodes . . . such that the one or more surgical
meshes ... are sealed on the internal side ... of the tissue.” {Id. 161.)
Claims 10, 12—14, and 18—23 are on appeal. Claim 10 is the only
independent claim and reads as follows (emphasis added):
10. A hernia repair system, comprising:
a surgical mesh including at least one electrode embedded
therein;
at least one electrosurgical instrument configured to
position the surgical mesh adjacent tissue in an underlying tissue
site; and
wherein the at least one electrosurgical instrument is
configured to selectively apply an effective amount of pressure
and electrosurgical energy to the at least one electrode embedded
within the surgical mesh such that upon application of
electrosurgical energy and pressure, the surgical mesh seals to
one side of the tissue at the underlying tissue site.
DISCUSSION
The Examiner has rejected claims 10, 12—14, and 18—20 under 35
U.S.C. § 103(a) as obvious based on Henderson2 and Callas.3 (Final Action4
3.) The Examiner has rejected claims 21—23 under 35 U.S.C. § 103(a) as
2 US 2008/0188874 A1 (publ. Aug. 7, 2008).
3 US 2007/0043416 A1 (publ. Feb. 22, 2007).
4 Office Action mailed Mar. 7, 2016.
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Application 14/093,705
obvious based on Henderson, Callas, and Butsch.5 (Final Action 4—5.) The
same issue is dispositive for both rejections.
The Examiner finds that “Henderson discloses a hernia repair system
(hernia mesh spreader), comprising: a surgical mesh (18); [and] at least one
electro surgical instrument configured to position the surgical mesh adjacent
tissue in an underlying tissue site.” {Id. at 3.) The Examiner finds that
Henderson’s instrument can be configured to perform electro-cauterization
to attach the mesh to tissue, and, therefore, meets the “wherein” clause of
claim 10. {Id.)
The Examiner finds that Henderson does not teach an electrode
embedded in its mesh, but “Callas discloses an implantable electrode array
that includes a mesh structure (support 32 having filaments 36) with
electrodes (34) embedded therein.” {Id.) The Examiner concludes that it
would have been obvious “to have included electrodes in the surgical mesh
of Henderson to allow for sensing or mapping the target location, or
providing electrical therapy thereto (Callas, abstract).” {Id.)
Appellant argues that,
[g]iven that the electrodes 34 of the Callas device are
merely described as fixed “on” the support 32, and that the
filaments 36 of support 32 are described as “fixed together” and
“cross to define a mesh”, Appellant submits that a person of
ordinary skill in the art would not have understood the electrodes
34 of the Callas device to have been “embedded in” the support
32 of the Callas device.
(Appeal Br. 7, citing Callas 135.)
5 US 2007/0293878 A1 (publ. Dec. 20, 2007).
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Application 14/093,705
We conclude that, regardless of whether the electrodes of Callas’
device would be considered “embedded in” its mesh, the Examiner has not
shown a persuasive reason why a person of ordinary skill in the art would
have combined the teachings of Henderson and Callas. “An examiner bears
the initial burden of presenting a prima facie case of obviousness.” In re
Huai-Hung Kao, 639 F.3d 1057, 1066 (Fed. Cir. 2011). “Obviousness
requires more than a mere showing that the prior art includes separate
references covering each separate limitation in a claim under examination.”
Unigene Labs., Inc. v. Apotex, Inc., 655 F.3d 1352, 1360 (Fed. Cir. 2011).
“Rather, obviousness requires the additional showing that a person of
ordinary skill at the time of the invention would have selected and combined
those prior art elements in the normal course of research and development to
yield the claimed invention.” Id.
Henderson discloses “a device for surgically treating hernia.”
(Henderson 17.) The device includes a central aperture in which a primary
rod can slide to move extension arms at the distal end to an extended
position. (Id.) “The arms are disposed to apply the surgical repair material
such as a mesh.” (Id.) The device can also include an attaching mechanism
to secure the repair material to the abdominal wall. (Id. at 8.) Attaching
mechanisms include “heating elements that use electrical current to
activ[at]e a heat-activated adhesive on the surgical mesh.” (Id. 148.) The
Examiner acknowledged that Henderson’s device does not include an
electrode embedded in the surgical mesh.
Callas discloses “[a]n implantable electrode array for providing a
plurality of electrodes in communication with a target.” (Callas, Abstract.)
Callas describes the relevant technical field as “[ijmplanted medical devices
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Application 14/093,705
that incorporate electrode arrays, for example, implanted cardiac rhythm
management devices or systems that include . . . electrode arrays for sensing
and/or treatment.” {Id. 12.) Callas states that “[t]he electrode array 20 has a
plurality of electrodes that provide rapid mapping and rapid, efficient
therapeutic delivery to a patient. Moreover, such an electrode array
provide[s] a physician with more pacing options based on a greater number
of electrodes and greater control, i.e., activation/deactivation, of electrodes.”
{Id. 129.)
The Examiner reasons that it would have been obvious “to have
included electrodes in the surgical mesh of Henderson to allow for sensing
or mapping the target location, or providing electrical therapy thereto.”
(Final Action 3.) This reasoning, however, disregards the different purposes
and operation of the mesh structures of Henderson and Callas. Henderson’s
surgical mesh is attached to the site of a hernia in an abdominal wall as a
surgical repair material (Henderson 17), while Callas’ mesh structure
functions to surround a target organ and situate an array of electrodes on the
organ for sensing and delivering electrical impulses (Callas Tflf 4, 29, 35).
The Examiner has not provided any persuasive reason for concluding that a
person of ordinary skill in the art would have considered the functions
performed by Callas’ electrodes to be useful in hernia repair, and therefore
has not persuasively shown that the posited combination would have been
obvious.
For this reason, we reverse the rejection of claim 10, and dependent
claims 12—14 and 18—20, under 35 U.S.C. § 103(a) based on Henderson and
Callas. We also reverse the rejection of claims 21—23 under 35 U.S.C.
§ 103(a) based on Henderson, Callas, and Butsch because the Examiner has
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not cited any disclosure in Butsch that makes up for the deficiency discussed
above.
SUMMARY
We reverse both of the rejections on appeal.
REVERSED
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