Ex Parte Olsen et al

Patent Trial and Appeal Board

Sep 29, 2017

13264013 (P.T.A.B. Sep. 29, 2017)

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.
13/264,013 10/12/2011 James M. Olsen P0034474.USN2 1898
87562 7590
Medtronic - WK
P.O. Box 71355
Marietta, GA 30007-1355
EXAMINER
NGUYEN, TIN DUC
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
10/03/2017 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):
tina @ witherskey s. com
medtronic_neuro_docketing @ cardinal-ip.com
j eramie @ witherskey s. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JAMES M. OLSEN, MICHAEL R. KLARDIE,
RICHARD T. STONE, CHAD Q. CAI, SPENCER M. BOUDHUS,
MARK J. CONWAY, and TIMOTHY R. ABRAHAM
Appeal 2016-007294
Application 13/264,0131
Technology Center 3700
Before ERIC B. GRIMES, JOHN G. NEW and DAVID COTTA,
Administrative Patent Judges.
COTTA, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of guiding, and a kit comprising, an implantable medical lead. The
Examiner rejected the claims on appeal as anticipated under 35 U.S.C.
§ 102(b) and as obvious under 35 U.S.C. § 103(a).
We affirm-in-part.
1 According to Appellants, the real party in interest is Medtronic, Inc., a
subsidiary of Medtronic pic. App. Br. 3.
Appeal 2016-007294
Application 13/264,013
STATEMENT OF THE CASE
The Specification states: “Implantable medical systems including
implantable medical devices (IMD) and associated implantable medical
leads provide functions such as stimulation of muscle or neurological tissue
and/or sensing of physiological occurrences within the body of a patient.”
Spec. 1. “To force the lead though the body to the stimulation site, a stylet is
inserted into a lumen of the lead.” Id. at 2. “The stylet is torsionally stiff so
that rotating the stylet hub on the proximal end results in the bent tip on the
distal end rotating as well.” Id. “When a new direction is needed, the doctor
reaches back to the end of the stylet to again rotate the stylet hub.” Id. The
Specification explains that prior art IMDs were difficult for doctors to work
with:
While steering the lead with the stylet hub is effective at rotating
the distal tip of the stylet, it can be cumbersome for the doctor.
The doctor works directly with the lead at the site of the
introducer needle to apply an insertion force, but the remainder
of the lead to be implanted, and hence the remainder of the stylet,
may extend behind the doctor for a significant distance. Thus, the
doctor may have to reach back to the proximal end of the lead to
grasp the stylet hub each time a steering input is needed.
Reaching back and forth between the lead at the introducer
needle and the stylet hub can be time consuming and
burdensome.
Id.
Appellants’ claimed methods and kits address these problems “by
providing a rotational coupling between a torsionally stiff lead and a stylet.”
Id. The Specification explains that “[t]he rotational coupling between the
torsionally stiff lead body and the stylet allows the rotation being applied to
the point on the lead body to be imparted to the stylet.” Id. As a result,
“when a doctor rotates the lead body at the site of the introducer needle, the
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Application 13/264,013
distal tip of the stylet also rotates without the doctor being required to apply
the rotation to the stylet hub.” Id.
Claims 1, 3—9, and 11—23 are on appeal. Claims 1, 9 and 17 are
illustrative and read as follows (emphasis added to highlight limitations at
issue):
1. A method of guiding an implantable medical lead,
comprising:
providing the implantable medical lead with an elongated
insulative body providing a length of the lead and with a torsional
stiffness over the length of the implantable medical lead, the
torsional stiffness being sufficient to impart rotation over the
length of the lead when rotation is applied at a point along the
length that includes the torsional stiffness; and
upon insertion of a stylet with a distal guide bend into a
lumen defined by the elongated insulative body of the
implantable medical lead, providing a rotational coupling of the
stylet to a coupling feature that is within the lumen and that is
defined by the elongated insulative body of the implantable
medical lead such that imparting rotation directly to the
implantable medical lead at the point along the length imparts
rotation to the stylet to direct the distal guide bend.
9. An implantable medical lead kit, comprising:
an implantable medical lead with an elongated insulative
body providing a length of the lead and with a torsional stiffness
over the length of the implantable medical lead, the torsional
stiffness being sufficient to impart rotation over the length of the
lead when rotation is applied at any point along the length that
includes the torsional stiffness; and
a stylet within a lumen defined by the elongated insulative
body of the implantable medical lead, the stylet having a distal
guide bend and the stylet being rotationally coupled to a coupling
feature that is within the lumen and that is defined by the
elongated insulative body of the implantable medical lead when
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Application 13/264,013
present within the lumen such that imparting rotation directly to
the implantable medical lead at one or more points along the
length imparts rotation to the stylet to direct the distal guide
bend.
17. A method of guiding an implantable medical lead,
comprising:
inserting a stylet with a distal guide bend into a lumen of
the implantable medical lead to rotationally couple the stylet to
an elongated insulative body of the lead that provides a length of
the lead, that provides a coupling feature that engages the stylet,
and that defines the lumen such that imparting rotation directly
to the implantable medical lead at one or more points along the
length imparts rotation to the stylet; and
directing the implantable medical lead in a desired
direction by imparting rotation directly to the implantable lead to
cause rotation of the stylet to a desired rotational position,
wherein the distal guide bend urges the implantable medical lead
in the desired direction; and
applying insertion force to the implantable medical lead.
App. Br. 9-12.
The claims stand rejected as follows:
Claims 1, 5, 9, 13, 17 and 19—23 were rejected under 35 U.S.C.
§ 102(b) as anticipated by Dutcher or, in the alternative, under 35 U.S.C. §
103(a) as obvious over the combination of Dutcher2 and Reddy.3
Claims 3, 4, 6, 11, 12, and 14 were rejected under 35 U.S.C. § 103(a)
as obvious over the combination of Dutcher, Reddy and Cookston.4
2 Dutcher et al., US Patent No. 4,350,169, issued Sept. 21, 1982 (“Dutcher”).
3 Reddy et al., US Patent Publication No. 2009/0259272 Al, published Oct.
15, 2009 (“Reddy”).
4 Cookston et al., US Patent No. 6,132,390, issued Oct. 17, 2000
(“Cookston”).
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Application 13/264,013
Claims 7, 8, 15, 16, and 18 were rejected under 35 U.S.C. § 103(a) as
obvious over the combination of Dutcher, Reddy, and Hoegh.5
ANALYSIS
Dutcher discloses “[a] body implantable lead and a stiffening stylet
with a flexible tip for imparting rigidity to the lead to facilitate attachment of
the lead to an internal body organ and for transmitting torque to the distal
end of the lead.” Dutcher Abstract. Dutcher’s device is illustrated in Figure
1 (reproduced below).
the present invention.” Id. at col. 2,11. 44-46. Dutcher’s device includes an
“elongated lead 10” {id. at col. 2,1. 61), “a jacket or sleeve 16 of electrically
insulating material” {id. at col. 2,1. 67—68), a “circular corkscrew or helix
42” with a “sharpened tip 48” {id. at col. 3,11. 7—11), and a “stylet 20.” Id. at
col. 4,1. 25. “There is also provided in chamber 34 at the distal end of lead
10, a member 54 which takes the form of a piston having a generally
circular cross section and has a proximal end at which is located a slotted
head 58 and a distal end portion 60 which is somewhat smaller in cross
sectional diameter than head 58.” Id. at col. 4,11. 16—20. The piston has a
5 Hoegh et al., US Patent Publication No. 2005/0222658, published Oct. 6,
2005 (“Hoegh”).
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Application 13/264,013
“slot 61 in the proximal end thereof and is adapted to receive the distal end
of stylet 20 which terminates at its distal end in a screwdriver tip 62.” Id.
col. 4,11. 22-25.
In rejecting the pending claims, the Examiner found that Dutcher
disclosed all of the elements of claim 1. With respect to the requirement for
“imparting rotation directly to the implantable medical lead at the point
along the length imparts rotation to the stylet to direct the distal guide bend,”
the Examiner found that the lead in Dutcher inherently included this
element. The Examiner explained:
[T]he lead inherently turns the stylet when the stylet is inserted
into the lead because screwdriver tip 62 (Figs. 3 and 1; col. 3:
lines 51-58) of the stylet engages with non-cylindrical slot 61 of
the lead (Fig. 1; col. 4: lines 41-45). Since the stylet is locked
with the lead by the rotational coupling (i.e., screwdriver tip 62
of the stylet coupled with non-cylindrical slot 61 of the lead),
grab at any point along the lead body will turn the lead and the
stylet together.
Ans. 3. In the alternative, if not inherently disclosed in Dutcher, the
Examiner found that Reddy disclosed the application of torque at the lead
body to impart rotation to the stylet. Final Act. 3^4. The Examiner thus
concluded that it would have been obvious to provide a step of imparting
rotation to the stylet via rotation of the lead “in order to provide an
alternative application of torque that is at the implantable medical lead
body.” Id. at 4.
We agree with the Examiner that the claims 1,5,9, 13,21, and 22
would have been obvious over the combination of Dutcher and Reddy.
However we find that the Examiner has not met the burden of establishing a
prima facie case of obviousness with respect to claims 17—20 and 23.
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Application 13/264,013
Appellants argue all three rejections together based on limitations
present in independent claims 1,9, and 17. Accordingly, we address all
three rejections together.
Claims 1 and 9 and claims depending therefrom
Appellants argue that Dutcher does not disclose a “coupling feature
that is within the lumen and that is defined by the elongated insulative body”
as required by claims 1 and 9. App. Br. 5. In Dutcher, Appellants contend,
the coupling feature is provided by a slot 61 in a piston. Id. Appellants
argue “[a]s the piston 54 is an entirely separate element from the insulative
body 16, the slot 61 of piston 54 is NOT defined by the lead body 16.” Id.
We are not persuaded.
Appellants’ argument that “slot 61 of piston 54 is NOT defined by the
lead body 16” assumes that slot 61, and only slot 61, makes up the “coupling
feature.” We find, however, that the slot is an integral part of the piston.
When identifying the “coupling feature,” the slot cannot be divorced from
the material that not only surrounds it, but engages the stylet to create the
coupling. Appellants do not offer a construction of the term “coupling
feature” that would exclude the material surrounding a mating opening like
slot 61. Nor do we find support for such a construction in the Specification,
particularly when the claims and Specification are considered under our
broadest reasonable construction standard. See, In re Morris, 127 F.3d
1048, 1054 (Fed. Cir. 1997) (“[T]he PTO applies to the verbiage of the
proposed claims the broadest reasonable meaning of the words in their
ordinary usage as they would be understood by one of ordinary skill in the
art, taking into account whatever enlightenment by way of definitions or
otherwise that may be afforded by the written description contained in the
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Application 13/264,013
applicant’s specification.”); In re Zletz, 893 F.2d 319, 321 (Fed. Cir. 1989)
(“during patent prosecution when claims can be amended, ambiguities
should be recognized, scope and breadth of language explored, and
clarification imposed.”). Accordingly, we find the Dutcher’s slot-containing
piston meets the requirement of claims 1, 9, and 17 for a “coupling feature.”
Having determined that Dutcher’s piston is a “coupling feature,” it is
necessary to determine whether the piston is “defined by the elongated
insulative body” as required by claims 1 and 9. In Dutcher, a jacket or
sleeve 16 corresponds to the “elongated insulative body” of the claims. The
jacket/sleeve expands in circumference at the distal end of the device such
that the piston marks the limits of (defines) the jacket/sleeve and the
jacket/sleeve marks the limits of (defines) the piston. See Fig. 1 (reproduced
above). Accordingly, we find that Dutcher’s coupling feature is defined by
the elongated insulative body.
Appellants argue that Reddy does not disclose applying torque to the
stylet in order to rotate the lead body. Reply. Br. 2—3. Appellants contend
that paragraph 23 of Reddy merely discloses that rotating the lead body
rotates the fixation helix, and that Reddy says nothing about also rotating the
stylet. Id.
Reddy discloses “medical electrical leads configured for mapping and
pacing ... in a heart of a patient.” Reddy 12. As shown in Figures 2A and
2B (reproduced below), Reddy’s device includes a “lead body 24” {id. at 1
21), a “fixation helix 38” having a “sharpened tip portion 44” {id. at 123),
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and a “stylet lumen 26” that “enables the use of a stiffening stylet wire 46 to
deliver the lead 14 to the desired location.” Id. at |25.
^
1,
FIS. 2A r
45
FIS. 2B
Figure 2A is “a plan view of a lead of [Reddy’s] stimulation and pacing
system” and Figure 2B is “a cross-sectional view of the lead of FIG. 2A.”
Id. at || 8—9.
As Appellants recognize, paragraph 23 of Reddy expressly
contemplates rotating the lead body in order to rotate the fixation helix. Id.
at 123 (“In an exemplary embodiment, the lead 14 has as close to infinite
torsional stiffness as possible and a torque transfer of about 1:1 such that one
turn of the proximal connector assembly 42 or lead body 24 is transferred to
the fixation helix 38 with no to minimal attenuation.”). Reddy also discloses
that the lead body, the stylet and the helix rotate together. Id. at 127 (“the
lead body 24 and fixation helix 38 can be rotated with a bladed stylet
configured to engage a feature at the distal end 34 of the lead 14 (shown in
FIG. 3 below).”). Appellant tries to discount the disclosure of paragraph 27
on the ground that it discusses an alternative embodiment than that of Figure
2 (which is discussed in paragraph 23) (App. Br. 7), but Figure 3 is
described in Reddy as a side view of the lead of Figures 2A and 2B. Reddy
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110. Reddy further discloses that the stylet may be a “locking stylet” {id. at
125) and that the stylet may be “configured to mate with and engage the
recess 56 of the shank portion 50 of the distal tip assembly 48” and to
“transmit a torque applied at the handle 64 [of the stylet] to the distal tip
assembly 48 to rotate the lead body 24 and the fixation helix 38.” Id. 130.
In view of these teachings, we find that a preponderance of the evidence
supports the Examiner’s finding that Reddy discloses a device in which
rotating the lead also rotates the stylet.
Accordingly we affirm the Examiner’s rejection of claims 1 and 9.
Because they were not argued separately, we also affirm the Examiner’s
rejection of dependent claims 3—8, 11—16, 21 and 22.
Claim 17 and claims depending therefrom
Claim 17 requires “an elongated insulative body of the lead that
provides a length of the lead, that provides a coupling feature that engages
the stylet, and that defines the lumen.” While not a model of clarity, we
understand the “provides a coupling feature” to refer to the elongated
insulative body. Thus the elongated insulative body must provide a coupling
feature, which we understand to mean that the insulative body itself forms a
coupling feature.
In Dutcher, the elongated insulative body defines a coupling feature,
but it does not itself form a coupling feature. As the Examiner does not
provide any reason why the skilled artisan would modify Dutcher so that the
elongated insulative body forms a coupling feature, we reverse the
Examiner’s rejection of claim 17. We also reverse the Examiner’s rejection
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Application 13/264,013
of dependent claims 18—20 and 23 because they rely upon the underlying
rejection of claim 17.
SUMMARY
For the reasons set forth herein, and those provided in the Examiner’s
Answer and Final Office action, we affirm the Examiner’s rejection of
claims 1,5, 9, 13,21, and 22 as obvious over the combination of Dutcher
and Reddy, the Examiner’s rejection of claims 3, 4, 6, 11, 12, and 14 as
obvious over the combination of Dutcher, Reddy and Cookston, and the
Examiner’s rejection of claims 7, 8, 15, and 16 under 35 U.S.C. § 103(a) as
obvious over the combination of Dutcher, Reddy, and Hoegh.
For the reasons set forth herein, we reverse the Examiner’s rejection
of Claims 17, 19—20, and 23 as obvious over the combination of Dutcher and
Reddy and the Examiner’s rejection of claim 18 as obvious over the
combination of Dutcher, Reddy, and Hoegh.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1).
AFFIRMED-IN-PART
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