Randy Westlund et al.

Patent Trials and Appeals Board

Oct 26, 2020

2020000327 (P.T.A.B. Oct. 26, 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.
13/045,435 03/10/2011 Randy W. Westlund 93478-0019-0301 2918
29052 7590 10/26/2020
EVERSHEDS SUTHERLAND (US) LLP
999 PEACHTREE STREET, N.E.
SUITE 2300
ATLANTA, GA 30309
EXAMINER
LOUIS, RICHARD G
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
10/26/2020 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):
patentdocket@eversheds-sutherland.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RANDY W. WESTLUND, PETER ANDREW CROSBY, and
DAN SACHS

Appeal 2020-000327
Application 13/045,435
Technology Center 3700
Before JOHN C. KERINS, JILL D. HILL, and GEORGE R. HOSKINS,
Administrative Patent Judges.
HILL, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1, 7, 10–12, 14, 15, 17, and 20–22.
Non-Final Act. 1. We have jurisdiction under 35 U.S.C. § 6(b). Arguments
for this case were heard via telephone on October 8, 2020.
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 party in interest as Mainstay Medical
Limited. Appeal Br. 3.
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BACKGROUND
Independent claims 1 and 14 are pending. Independent claim 1,
reproduced below, illustrates the claimed invention, with certain limitations
italicized:
1. A method of implanting an electrode lead for use in
neuromuscular electrical stimulation to improve muscle tone,
strength or endurance, comprising:
providing an electrode lead having a distal end including
at least first and second electrodes, the electrode lead configured
to be implanted with a trajectory that includes one or more
multifidus fascicles;
providing a tool for implanting the electrode lead
comprising a cannula having a lumen and a tip configured for
blunt dissection, the lumen configured to permit the electrode
lead to extend therethrough for implantation in a vicinity of a
medial branch of a dorsal ramus nerve;
separating a multifidus muscle from a longissimus thoracis
muscle along naturally occurring tissue planes therebetween
using the tip of the tool to provide a path to the one or more
multifidus fascicles associated with the lumbar spine; and
implanting the distal end of the electrode lead through the
lumen of the cannula in the vicinity of the medial branch of the
dorsal ramus nerve.
REFERENCES
The prior art relied upon by the Examiner is:
Name Reference Date
Mrva US 2006/0004429 A1 Jan. 5, 2006
Boyer US 2006/0293662 A1 Dec. 28, 2006
Gerber US 2007/0100408 A1 May 3, 2007
Whitehurst US 2007/0129780 A1 Jun. 7, 2007
Sachs US 2008/0228241 A1 Sep. 18, 2008
Selover US 2010/0174326 A1 Jul. 8, 2010
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REJECTIONS
I. Claims 1, 10, and 11 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Sachs, Mrva, and Selover. Non-Final Act. 3.
II. Claim 7 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Sachs, Mrva, Selover, and Gerber. Non-Final Act. 4.
III. Claim 12 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Sachs, Mrva, Selover, and Boyer. Non-Final Act. 5.
IV. Claims 14, 15, 17, 20, and 21 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Sachs, Mrva, Selover, and Whitehurst. Non-
Final Act. 6.
V. Claim 22 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Sachs, Mrva, Selover, Whitehurst, and Boyer. Non-Final
Act. 8.
OPINION
Rejections I – III: Claims 1, 7, and 10–12
The Examiner finds that Sachs discloses a method for implanting an
electrode lead 12 for use in neuromuscular electrical stimulation to improve
muscle tone, strength or endurance, the method including many limitations
of the claimed invention. Non-Final Act. 3. The Examiner finds, however,
that Sachs does not disclose, inter alia, providing a tool for implanting the
electrode lead, wherein the tool is a cannula having a lumen and a tip
configured for blunt dissection, the lumen configured to permit the electrode
lead to extend therethrough for implantation in a vicinity of a medial branch
of a dorsal ramus. Id. The Examiner finds that Mrva discloses, inter alia,
implanting an electrode lead for neuromuscular electrical stimulation, the
method including “providing a blunt dissection tool (tunneling tool 40, see
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paragraph [0089]) for implanting the electrode lead, wherein the blunt
dissection tool is a cannula having a lumen and a tip (blunt tip 62, see
paragraph [0089]) configured for blunt dissection.” Id. at 3–4. The
Examiner concludes that it would have been obvious to modify Sach’s
method to include Mrva’s tool for implanting the electrode lead “to precisely
deliver[] the lead to the medial branch of the dorsal ramus.” Id. at 4.
The Examiner then finds that Selover provides an electrode
implanting cannula tool 200 having a lumen and a tip configured for blunt
dissection, which “separat[es] multifidus muscle from a longissimus thracis
muscle along naturally occurring tissue planes using a blunt dissection tool
to provide a path to the target tissue associated with the lumbar spine, for the
purpose of minimizing trauma to the muscles while the path is being
created.” Non-Final Act. 4 (citing Selover ¶¶ 42, 52, 53). The Examiner
concludes that it would have been obvious to modify Sachs’ method to
include “separating multifidus muscle from a longissimus thracis [sic]
muscle along naturally occurring tissue planes using a blunt dissection tool
to provide a path to the target tissue associated with the lumbar spine, for the
purpose of minimizing trauma to the muscles while the path is being
created.” Id.
Appellant argues, inter alia, that Mrva’s tunneling tool is functionally
distinct from the claimed cannula, because Mrva’s tunneling tool 40 does
not deliver its electrode to a target location, and instead creates a pathway
through adipose tissue from the already-implanted electrode lead to an
implanted pulse generator. Appeal Br. 9. Thus, Appellant argues, Mrva’s
tunneling tool 40 has a “completely different function” than the claimed
invention. Id. at 10. Appellant argues that, therefore, a skilled artisan
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reading Mrva would not have used its blunt-tipped device to implant the
electrode. Id.
The Examiner responds that Mrva “teaches using tunnel tool 40 to
deliver a lead, which is recognized to be useful at other locations in the
body,” and “[l]ogic, sound scientific reasoning suggest it would be relevant
to Sachs which discloses using a tool to deliver a lead to a location.” Ans.
4–5 (citing Mrva ¶ 40). The Examiner further contends that Mrva does not
disclose its tunneling tool and lead being “distinct from leads or tools used to
implant leads in other areas of the body,” and Appellant’s Specification does
not “recognize any functional ability connected to the size of the lead or tool
which is distinct from a lead structured to be implanted in and provide
stimulation to an adipose tissue region.” Id. at 5. The Examiner notes that
Appellant describes the claimed tool being “passed through a small incision
and a tract is created using blunt dissection,” and the structure Appellant
uses “to perform this technique is a cannula . . . with a blunt tip.” Id. at 6.
According to the Examiner, Mrva likewise discloses passing a blunt-tipped
cannula “through an incision and a tract is created using blunt dissection,”
which results in “the exact same structure used to perform the same steps
[A]ppellants describe in their specification . . . for separating muscles to
provide a path.” Id. The Examiner explains that Sachs is relied on for
“using a tool to implant the distal end [of] an electrode in the vicinity of the
medial branch of the dorsal ramus,” and that the rejection is based on the
obviousness of modifying Sachs to use Mrva’s tool “to achieve the same
recognized result of implanting the lead in the vicinity of the medial branch
of the dorsal ramus.” Id. The Examiner contends that Appellant has not
provided any reason why using Mrva’s tool in Sachs “would make an
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operator unable to implant a lead in the vicinity of the medial branch of the
dorsal ramus.” Id.
The Examiner relies on Selover for its teaching that “blunt dissection
comes with the large benefit of avoiding injury to surrounding tissue” to
provide a motivation for employing Mrva’s tunneling tool 40 to implant
Sachs’ electrode. Id. at 7 (citing Selover ¶¶ 42, 53); 9 (“Selover which
would suggest using a tool to implant a distal end of a structure similar lead
in the vicinity of the medial branch of the dorsal ramus, using blunt
dissection, for the purpose of minimizing trauma to the muscles while the
path is being created.”). According to the Examiner, “[m]ere lack [of]
mention of the lower back does not necessarily mean” that Mrva’s tunneling
tool 40 “would not be suitable to address the complexities involved with
tunneling through the muscles of the lower back.” Id. at 8. Mrva uses “the
same structure (cylindrical tool, blunt tip) and same technique (blunt
dissection), which the [A]ppellants are arguing address the complexities
involved with tunneling through the muscles of the lower back.” Id.
Appellant replies that Mrva teaches distinct tools for (1) implanting
the lead 12 near the pubic symphysis, and (2) tunneling a path for a proximal
end of the implanted lead 12 to connect with a pocket incision site for pulse
generator 18. Reply Br. 2 (citing Mrva ¶¶ 78, 84, 86, 89, and 91). Indeed,
Mrva firstly uses a needle to implant its lead 12, and secondly uses a blunt
tool to tunnel a path to the pulse generator incision pocket. Id. Thus,
Appellant argues, a skilled artisan would have understood “to use the tools
and teachings of Mrva to implant the Sachs lead by advancing a
needle/sleeve to the target site, . . . withdrawing the needle, passing the distal
end of the Sachs lead through the sleeve to the location, and withdrawing the
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sleeve.” Id. at 3. According to Appellant, Mrva’s tunneling tool 40 “has
nothing at all to do with implanting the distal end of [its] lead 12 for
stimulation.” Id. Thus, Appellant argues, absent impermissible hindsight, it
would not have been obvious to a skilled artisan to use Mrva’s tunneling tool
40 to implant the lead, particularly when Mrva has a tunneling tool 40 and
instead uses a needle 30 and sleeve 32 for lead implantation. Id. at 3–4.
Appellant also argues that Mrva’s tunneling tool 40 “does not have
the same structure as the claimed tool for implanting the electrode lead”
because the claimed tool “is provided for implanting the distal end of the
electrode lead (the end having electrodes for stimulation) in the vicinity of
the medial branch of the dorsal ramus nerve,” and Mrva’s tunneling tool 40
“is structured to receive the proximal end of lead 12 (the end external to the
patient’s body) for subcutaneously coupling with implantable pulse
generator 18.” Reply Br. 5. Appellant reasons that an electrode lead used in
the claimed invention would include a fixation feature permitting a distal
end of the lead to be attached to bone, and a skilled artisan “would have
understood that the claimed tool for implanting the electrode lead must have
a lumen sized and shaped to accommodate not only the lead body, but also
the fixation feature at the distal end of the lead.” Id.
Appellant also argues that Mrva’s tunneling tool 40 is not “configured
to deliver an electrode lead configured for implantation in the back” because
a skilled artisan “would not have even considered using tunneler tool 40 of
Mrva in the manner suggested by the Examiner’s Answer to arrive at the
claimed invention.” Reply Br. 7–8.
Appellant then contends that Mrva’s tunneling tool 40 “which is
specifically designed for blunt dissection subcutaneously of soft adipose
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tissue, is structurally distinct from tool 200 of Selover, which is configured
for blunt dissection to deliver a rigid device to be fixed to a vertebra.” Reply
Br. 9 (citing to Crosby Dec. ¶ 32 (“[t]he tools and techniques required are
unique to each clinical or surgical problem to be solved, and the existence of
a blunt dissection technique for one field or location, e.g., blunt dissection to
place a pneumothorax drain, could in no way be used as a predicate for a
different location or clinical problem, e.g., blunt dissection used in
mammoplasty-breast reconstruction.”)). Thus, Appellant argues, a skilled
artisan would not have been motivated to use Mrva’s tunneling tool 40 in
Selover’s surgical procedure because, “[s]imply put, there are no multifidus
muscles in the adipose tissue of Mrva to be separated from (nonexistent)
longissimus thoracis muscles.” Id. Thus, Appellant argues, it would not
have been obvious to “combine the tools of Mrva with the teachings of
Selover in the manner suggested by the Examiner to implant the Sachs lead
to arrive at the present invention.” Id.
Having considered the disclosures of Sachs, Mrva, and Selover in
their entireties and in detail, and the arguments set forth by the Examiner
and Appellant, we determine as follows.
We agree with the Examiner that Sachs discloses a method of
implanting an electrode lead for use in neuromuscular electrical stimulation,
including many limitations of the claimed invention, except for “providing a
tool for implanting the electrode lead comprising a cannula having a lumen
and a tip configured for blunt dissection, the lumen configured to permit the
electrode lead to extend therethrough for implantation in a vicinity of a
medial branch of a dorsal ramus nerve,” and “implanting the distal end of
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the electrode lead through the lumen of the cannula” of the blunt-tipped tool.
See Non-Final Act 3.
Like Sachs, Selover discloses a technique to access a patient’s
vertebral body, but Selover employs a minimally invasive technique
employing a blunt-tipped instrument to separate muscles leading to the
vertebral body. See Selover ¶¶ 6–7, 12. Selover’s blunt-tipped instrument
has a delivery lumen providing access from the skin surface incision to the
vertebral body. Id. at ¶¶ 7–8. Selover, however, is concerned with
delivering a spinal fixation element, rather than an electrode lead. Id. at ¶ 7.
Selover more specifically discloses that its blunt member 206 on its tool 200
is adapted “to separate muscles along a muscle plane while . . . minimizing
trauma to the separated muscles.” Id. at ¶ 53. The shape of the blunt
member 206 can vary. Id. The tool 200 can include an inner tube in its shaft
202 for creating a divot in the vertebral bone, and for receiving a vertebral
bone drill. Id. at ¶ 54. According to Selover, one skilled in the art “will
appreciate that the tool 200 . . . can be adapted for a variety of other uses.”
Id. Further, according to Selover, it is a fat (adipose) layer between the
longissimus thoracis and multifidus muscles that the blunt tool navigates
through to separate the longissimus thoracis and multifidus muscles and
access the junction of the transverse process (TP) and the superior articular
process (SAP). Id. at ¶ 55. A k-wire is affixed at a target location, rather
than an electrode lead. Id. We consider Selover to disclose delivering a tool
to the vicinity of a medial branch of a dorsal ramus nerve, and a minimally-
invasive blunt instrument suitable to address the complexities involved in
tunneling from a skin surface incision through muscles of the lower back.
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Like Selover, Mrva discloses blunt dissection from a skin surface
incision through adipose tissue with a blunt tunneling tool 40 having a
lumen. See Mrva ¶¶ 14, 89. Like Sachs, Mrva discloses creating a
passageway for a nerve stimulation electrode lead 12. Id. at ¶¶ 14, 57.
Mrva’s blunt-tipped tunneling tool 40, however, is not used for implanting
Mrva’s electrode lead – Mrva’s needle 30 implants the electrode 16 at the
target stimulation location. Id. at ¶¶ 52–56. Thus, Appellant is correct that
Mrva’s tunneling tool is functionally distinct from the claimed blunt tool,
although we do not consider such functional distinction to be dispositive.
We are not persuaded by Appellant’s argument that Mrva’s tunneling tool 40
is structurally distinct from the claimed invention (Appeal Br. 8–9) merely
because it is functionally distinct – Appellant has not advised us of any
actual structure that distinguishes the claimed tool structure from Selover’s
blunt-tipped tool 200 or Mrva’s blunt-tipped tunneling tool 40. A lumen
sized and shaped to accommodate a lead and fixation feature (Reply Br. 5)
are not recited in claim 1. Because we discern no structural difference
between the claimed implanting tool and either Selover’s tool 200 or Mrva’s
tunneling tool 40, we cannot say that the blunt tools of Selover and Mrva are
not configured for electrode implantation or “to permit the electrode lead to
extend therethrough” for implantation. We likewise discern no structural
distinction between the blunt tools of Selover and Mrva (Reply Br. 9) based
on their differing uses.
Again, claim 1 recites providing an electrode lead implantation tool
“comprising a cannula having a lumen and a tip configured for blunt
dissection, the lumen configured to permit the electrode lead to extend
therethrough for implantation in a vicinity of a medial branch of a dorsal
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ramus nerve,” and “implanting the distal end of the electrode lead through
the lumen of the cannula in the vicinity of the medial branch of the dorsal
ramus nerve.”
Given that Sachs discloses implanting an electrode lead in a vicinity
of a medial branch of a dorsal ramus nerve, the question is whether a skilled
artisan, upon reviewing the disclosures of Mrva and Selover, would be
motivated to provide a blunt delivery tool such as Selover’s blunt tool 200
(for delivering a bone drill to a vicinity of a medial branch of a dorsal ramus
nerve) or Mrva’s tunneling tool 40 (for making an electrode lead pathway)
for implanting the electrode.
As for proffered motivation, regarding combining Sachs and Selover,
the Examiner concludes that it would have been obvious to modify Sachs’
method “such that it included the steps of separating multifidus muscle from
a longissimus thracis [sic] muscle along naturally occurring tissue planes
using a blunt dissection tool to provide a path to the target tissue associated
with the lumbar spine, for the purpose of minimizing trauma to the muscles
while the path is being created.” Non-Final Act. 4. We discern no error in
this conclusion. Regarding employing Mrva’s blunt tool, the Examiner
concludes that it would have been obvious to modify Sachs’ method to
include providing Mrva’s blunt tunneling tool 40 “for implanting the
electrode lead, . . . to precisely deliver[] the lead to the medial branch of the
dorsal ramus.” Id. The Examiner also contends that Mrva discloses “a
similar method of implanting an electrode lead (lead 12, see paragraph
[0089]) in an area close to the spine; see paragraph [0079]” and that “Mrva
teaches the utility of the tool and the steps of using it for the purpose of
directing a lead to its intended location. See paragraph [0089].” Ans. 3.
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Considering this reasoning set forth by the Examiner, we agree with
Appellant that the Examiner has not established prima facie obviousness.
Although Selover discloses blunt dissection to access the vicinity of
implantation disclosed in Sachs, Selover does not implant an electrode with
its blunt dissection tool 200. Similarly, Mrva does not implant an electrode
with its blunt tunneling tool 40 – Mrva relies on a needle 30 and sleeve 32,
even though it has the tunneling tool 40 available. It is, thus, unexplained by
the Examiner why a skilled artisan, in the absence of impermissible
hindsight, would employ either Selover’s or Mrva’s blunt tool to implant an
electrode. Lacking such reasoning, supported by a rational basis, we do not
sustain the rejection of claim 1, or claims 7 and 10–12 that depend
therefrom.
Rejections IV – V: Claims 14, 15, 17, and 20–22
The rejection of independent claim 14 is based on most of the findings
and conclusions as the rejection of independent claim 1. We again agree
with Appellant that the Examiner has not established prima facie
obviousness, because the Examiner has not set forth sufficient reasoning
why a skilled artisan would employ either Selover’s or Mrva’s blunt tool to
implant an electrode. Lacking such a rationally-supported reasoning, we do
not sustain the rejection of claim 14, or claims 15, 17, and 20–22 that depend
therefrom.
CONCLUSION
We do not sustain pending Rejections I–V.
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DECISION SUMMARY
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 10, 11 103(a) Sachs, Mrva, Selover 1, 10, 11
7 103(a) Sachs, Mrva, Selover,
Gerber
7
12 103(a) Sachs, Mrva, Selover,
Boyer
12
14, 15,
17, 20,
21
103(a) Sachs, Mrva, Selover,
Whitehurst
14, 15, 17,
20, 21
22 103(a) Sachs, Mrva, Selover,
Whitehurst, Boyer
22
Overall
Outcome
1, 7, 10–12,
14, 15, 17,
20–22

REVERSED