Martin T. Gerber

Patent Trials and Appeals Board

Jun 2, 2020

2019000700 (P.T.A.B. Jun. 2, 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.
11/606,627 11/30/2006 Martin T. Gerber P0027175.00/1023-602US01 6705
71996 7590 06/02/2020
SHUMAKER & SIEFFERT , P.A
1625 RADIO DRIVE , SUITE 100
WOODBURY, MN 55125
EXAMINER
LEE, ERICA SHENGKAI
ART UNIT PAPER NUMBER
3792
NOTIFICATION DATE DELIVERY MODE
06/02/2020 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):
pairdocketing@ssiplaw.com
rs.patents.five@medtronic.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte MARTIN T. GERBER
__________

Appeal 2019-000700
Application 11/606,627
Technology Center 3700
__________

Before TONI R. SCHEINER, ERIC B. GRIMES, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

SCHEINER, Administrative Patent Judge.

DECISION ON APPEAL

Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1–4, 10–13, 15, 19–23, and 38. We
have jurisdiction under 35 U.S.C. § 6(b).
We reverse.

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies the real parties in interest as
Medtronic Inc. of Minneapolis, Minnesota and Medtronic plc of Dublin,
Ireland. Appeal Br. 3 (entered June 6, 2018).
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BACKGROUND
Appellant’s invention is directed to a flexible apparatus for implanting
a therapy element (e.g., a neurostimulation lead) into a patient’s tissue. See
Spec. ¶¶ 6–8. According to the Specification, the apparatus comprises an
introducer “configured to preferentially flex . . . more easily in a particular
direction to help prevent the introducer from inadvertently flexing in a
direction that may damage tissue . . . during implantation of the therapy
element.” Id. ¶ 6.
STATEMENT OF THE CASE
Claims 1–4, 10–13, 15, 19–23, and 38 are pending and on appeal.
Claims 24–26, 28–32, and 35–37 have been withdrawn from consideration,
and claims 5–9, 14, 16–18, 27, 33, and 34 have been cancelled. Final Act. 3.
Claim 1, the sole independent claim on appeal, is representative of the
subject matter on appeal and reads as follows:
1. An apparatus configured to facilitate implantation of a
therapy element into tissue of a patient, the apparatus
comprising:
a dilator; and
a sheath defining an inner lumen configured to
interchangeably receive the dilator and the therapy element,
wherein a first portion of the dilator is configured to
preferentially flex in at least a first direction over at least a
second direction that is different from the first direction,
wherein a second portion of the dilator is configured to
preferentially flex in the second direction, the dilator being
configured to allow the first portion to flex in at least the first
direction and the second portion to flex in the second direction
at a same time, and wherein a cross-sectional shape of at least
one of the first portion or the second portion of the dilator
comprises an oval shape having a major axis and a minor axis,
the oval shape having a first outer dimension along the major
axis and a second outer dimension along the minor axis,
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wherein the first dimension is larger than the second dimension,
and the at least one of the first portion or the second portion of
the dilator being configured to preferentially flex about the
major axis due to the respective oval shape.
Appeal Br. 18.
The following rejections under pre-AIA 35 U.S.C. § 103(a) are before
us for review:
Claims 1–4, 11, 13, 19, 22, 23, and 38 as unpatentable over Mamo,2
Kucklick,3 and Avitall;4
Claim 10 as unpatentable over Mamo, Kucklick, Avitall, and Spear;5
Claim 12 as unpatentable over Mamo, Kucklick, Avitall, and
McKay;6
Claim 15 as unpatentable over Mamo, Kucklick, Avitall, and
Bowser;7 and
Claims 20 and 21 as unpatentable over Mamo, Kucklick, Avitall, and
Kupiecki.8
DISCUSSION
The Prior Art
Mamo
Mamo discloses a “minimally invasive instrument set for implanting
sacral stimulation leads compris[ing] at least a needle and a dilator that are

2 Mamo et al., US 2002/0147485 A1, published Oct. 10, 2002.
3 Kucklick et al., US 2005/0043682 A1, published Feb. 24, 2005.
4 Avitall, US 5,441,483, issued Aug. 15, 1995.
5 Spear et al., US 2002/0173785 A1, published Nov. 21, 2002.
6 McKay, US 2008/0009823 A1, published Jan. 10, 2008.
7 Bowser et al., US 6,419,674 B1, issued Jul. 16, 2002.
8 Kupiecki et al., US 2003/0225425 A1, published Dec. 4, 2003.
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particularly adapted to enable introduction of . . . neurostimulation lead
electrode(s) in operative relation to a sacral nerve.” Mamo ¶ 9.
“[T]he dilator comprises the assembly of a dilator body and a dilator
sheath that are inserted through the skin as an assembly and are separated to
enable introduction of the neurostimulation lead through the dilator sheath
lumen.” Id. ¶ 11. “The dilator is adapted to be introduced over [a] needle or
guide wire . . . whereupon the dilator body and guide wire are withdrawn,
leaving the dilator sheath.” Id. “The guide wire may be relatively stiff to
prevent bending or may be flexible to enable a degree of bending.” Id. ¶ 14.
Kucklick
Kucklick describes “a cannula and instrument port for use during
surgical procedures.” Kucklick ¶ 7. Figure 8 of Kucklick is reproduced
below:

Figure 8 depicts Kucklick’s instrument port 101 with distal cannula 102 and
surgical clamp 120 disposed within the cannula. According to Kucklick,
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“the cannula is flexible . . . [and] capable of accommodating curved,
malleable or flexible instruments used during various surgical procedures.”
Kucklick ¶ 48. “The cannula can bend along either axis 125 or 126,” and
“can be made to bend preferentially along one of those two axes. For
example, the cannula may be made wider along one axis, thus making the
cannula preferentially bend in the direction of the other axis.” Id.
Additionally, the cannula may have slots “sized and dimensioned for
preferential bending of the cannula.” Id. Kucklick further discloses that
“the instrument port’s rigid tube and cannula may be provided with different
cross sections to change how the cannula bends and to accommodate
differently shaped instruments. For example, a cannula having an elliptical
cross section is preferentially flexible on its minor axis.” Id. ¶ 66. Kucklick
teaches that the elliptical cross section “accommodates instruments having a
flat, narrow shape.” Id.
Avitall
Avitall discloses a “catheter tip with greatly increased multi-
directional sharp-angle flexibility” that “affords the catheter a greater
amount of ‘fine tuning’ by providing improved intricate or sophisticated
maneuverability enabling catheter use in hard-to-reach branching vessels.”
Avitall 3:60–64. “This is accomplished by the provision of any of several
unique catheter/sheath constructions which allow independent radical
deflection of one or more longitudinally spaced or abutting shaft deflection
segments disposed in the same or different directions at the behest of
associated control wires.” Id. at 3: 67–4:4.
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Figure 1B of Avitall is reproduced below:

Figure 1B of Avitall depicts a catheter with “dual directioned deflection” (id.
at 7:56–57) provided by “[a] pair of end or deflection segments . . . just
proximal of the electrode . . . and each includes a series of five (5) spaced
parallel lateral cuts in the form of discrete aligned notches 50 and 52 which
may be any desired length or shape” (id. at 7:42–46). The “set of cuts 52,
provided proximal to the distal set 50, may address a radially diverse
direction . . . and comprise a proximal deflection segment in the flexible tip
of the catheter.” Id. at 7:51–55.
The Examiner’s Rejections
The Examiner contends that the subject matter of claims 1–4, 11, 13,
19, 22, 23, and 38 would have been obvious over the combined teachings of
Mamo, Kucklick, and Avitall. In particular, the Examiner finds that Mamo’s
implantation apparatus is configured to interchangeably receive a dilator and
a neurostimulation lead (i.e., a therapy element). Non-Final Act. 4 (citing
Mamo ¶¶ 11, 93, Figs. 8a–c). The Examiner acknowledges that Mamo does
not disclose that “a first portion of the dilator is configured to preferentially
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flex in at least a first direction over at least a second direction that is
different from the first direction,” or that “a second portion of the dilator is
configured to preferentially flex in the second direction,” at the same time.
Id.
The Examiner turns to Kucklick for its disclosure of a mechanism for
preferential flexibility, and Avitall for its disclosure of multi-directional
flexibility. Non-Final Act. 4–6.
Specifically, the Examiner finds that Kucklick describes a cannula
with “an elliptical cross section or [in] other words, an oval cross section,”
wherein the cannula “bend[s] preferentially along one of two axes 125 or
126 by being ‘made wider along one axis, thus . . . preferentially bend[ing]
in the direction of the other axis.’” Non-Final Act. 5 (citing Kucklick ¶ 48).
The Examiner further finds that Avitall describes an elongated
medical device with “a first portion preferentially flexing in at least a first
direction over at least a second direction that is different from the first
direction,” and a second portion “configured to preferentially flex in the
second direction.” Non-Final Act. 5 (citing Avitall 7:42–50). According to
the Examiner, Avitall’s device is “configured to allow the first portion to
flex in . . . the first direction and the second portion to flex in the second
direction at the same time.” Id. (citing Avitall 7:42–8:3, Fig. 1B).
The Examiner contends it would have been obvious for one of
ordinary skill in the art “to incorporate [Kucklick’s] oval shaped cross-
sectional design” in Mamo, “to provide preferential flexing that allows for
improved intricate or sophisticated maneuverability.” Id. (citing Kucklick
¶ 48). Moreover, the Examiner contends it would have been obvious to
modify Mamo “to enable a first portion of the dilator to preferentially flex in
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the at least the first direction and a second portion of the dilator to
preferentially flex in the second direction different from the first direction,
and at [the] same time, as taught by Avitall in order to provide multi-
directional flexibility that allows for improved intricate or sophisticated
maneuverability enabling use in hard-to-reach locations of the body.” Id. at
5–6 (citing Avitall 3:60–67, 7:42–8:3).
Appellant’s Arguments
Appellant contends that “a person of ordinary skill in the art would
not have looked to both Avitall and Kucklick to modify Mamo’s dilator to
achieve preferential flexing in two portions of a dilator” (Appeal Br. 9),
because “Avitall already describes a configuration that ‘provides . . . multi-
directional flexibility that allows for improved intricate or sophisticated
maneuverability enabling use in hard-to-reach locations of the body’” (id.).
According to Appellant, modifying Mamo according to Avitall to achieve
multi-directional flexibility would not have resulted in a dilator with the
elliptical cross-sections required by claim 1. Id. at 10. Appellant contends
“[t]he Examiner failed to identify any particular reason why a person of
ordinary skill in the art would also have looked to Kucklick’s alleged
elliptical cross-section to modify Mamo’s dilator.” Id.
Appellant further contends the Examiner has failed to provide
evidence suggesting that it would have been obvious to use “an elliptical
cross-section when it was desired to have two different directions of
preferential flex” (Reply Br. 2), and “has failed to even explain how the two
different directions of preferential flex are allegedly achieved using an
elliptical cross-section” (id. at 2–3). Appellant emphasizes that “a stated
advantage of the elliptical cross section of Kucklick is that the ‘cannula also
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accommodates instruments having a flat, narrow shape’” (id. at 3), but “[a]
flat narrow instrument aligned with one of the elliptical cross sections would
seem to not then be aligned with the other elliptical cross sections” (id.).
Finally, Appellant contends “[i]n the absence of any suggestion otherwise
and without reliance on hindsight, the skilled artisan would have simply
used the solutions discussed in Avitall, which are specifically designed for
preferential bending in multiple directions.” Id.
Analysis
Having considered the evidence and arguments of record, we are not
persuaded that the Examiner has established that the teachings of Kucklick
and Avitall would have given one of ordinary skill in the art a reason to
modify Mamo’s device in the manner required by claim 1. In particular, we
are not persuaded that the prior art relied on would have led one of skill in
the art to modify Mamo to have two portions configured to preferentially
flex in two different directions, where at least one portion of preferential
flex is provided by an elliptical cross section.
As discussed above, Kucklick discloses that an elliptical cross section
provides preferential (i.e., directional) flexibility (Kucklick ¶ 66), while
Avitall discloses that one or more segments of different “directioned
deflection” can be provided by “spaced parallel lateral cuts in the form of
discrete aligned notches” (Avitall, 7:44–45). We agree with Appellant’s
reasoned assertion that a flat narrow instrument aligned with one elliptical
cross section would not then be aligned with another elliptical cross section
oriented in a different direction. Thus, we are not persuaded that the
Examiner has established that it would have been obvious for one of
ordinary skill in the art to reconfigure Mamo’s therapy element to
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preferentially flex in two different directions, where both regions of
preferential flex comprise an oval shape having a major axis and a minor
axis (i.e., corresponding to Kucklick’s elliptical cross-section). Nor has the
Examiner explained why the prior art would have led one of ordinary skill in
the art to provide two portions of preferential flex using two different
techniques—e.g., one portion with Kucklick’s elliptical cross section and
another portion with Avitall’s spaced parallel lateral cuts—when Avitall
already provides two different directions of flex using a single technique.
Thus, we are not persuaded that the Examiner has established that it would
have been obvious for one of ordinary skill in the art to reconfigure Mamo’s
therapy element to preferentially flex in two different directions, with at
least one region of preferential flex comprising an oval shape having a major
axis and a minor axis, configured to flex about the major axis, and another
region of preferential flex comprising spaced lateral cuts.
For the reasons discussed above, Appellant persuades us that the
Examiner has not established that Claim 1 would have been obvious over the
combined teachings of Mamo, Kucklick, and Avitall. We, therefore, reverse
the Examiner’s rejection of claim 1, as well as claims 2–4, 11, 13, 19, 22,
23, and 38, which depend from claim 1.
The Remaining Rejections
The underlying basis of the remaining rejections of claims 10, 12, 15,
20, and 21, which depend directly or indirectly from claim 1, is the
Examiner’s proposed combination of the teachings of Mamo, Kucklick, and
Avitall. As discussed above, the Examiner has not established that Claim 1
would have been obvious over the combined teachings of Mamo, Kucklick,
and Avitall. None of the additional references cited by the Examiner—
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Spear, McKay, Bowser, and Kupiecki—remedies this deficiency.
Accordingly, the remaining obviousness rejections are reversed as well.
CONCLUSION
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/
Basis
Affirmed Reversed
1–4, 11,
13, 19, 22,
23, 38
103(a) Mamo, Kucklick,
Avitall
1–4, 11, 13,
19, 22, 23,
38
10 103(a) Mamo, Kucklick,
Avitall, Spear
10
12 103(a) Mamo, Kucklick,
Avitall, McKay
12
15 103(a) Mamo, Kucklick,
Avitall, Bowser
15
20, 21 103(a) Mamo, Kucklick,
Avitall, Kupiecki
20, 21
Overall
Outcome
1–4, 10–13,
15, 19–23,
38

REVERSED