Ex Parte Soltis et al

Patent Trial and Appeal Board

Aug 31, 2017

13716704 (P.T.A.B. Aug. 31, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
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APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/716,704 12/17/2012 Brian D. Soltis 432469.000103 1702
42074 7590 09/05/2017
Faegre Baker Daniels LLP
PATENT DOCKETING - INTELLECTUAL PROPERTY (32469)
2200 WELLS FARGO CENTER
90 SOUTH SEVENTH STREET
MINNEAPOLIS, MN 55402-3901
EXAMINER
FLORY, CHRISTOPHER A
ART UNIT PAPER NUMBER
3762
NOTIFICATION DATE DELIVERY MODE
09/05/2017 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
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte BRIAN D. SOLTIS and KYLE P. TRUE1
Appeal 2016-005693
Application 13/716,704
Technology Center 3700
Before TAWEN CHANG, RYAN H. FLAX, and TIMOTHY G. MAJORS,
Administrative Patent Judges.
CHANG, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to an
implantable medical system and a method for anchoring a lead, which have
been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
STATEMENT OF THE CASE
Medical leads, for example electrical leads connected to a pacemaker,
may be anchored to a patient’s tissue via anchoring devices such as suture
sleeves, in order to help prevent lead migration and dislodgment. (Spec.
1 Appellants identify the Real Party in Interest as Cardiac Pacemakers, Inc.,
a wholly owned subsidiary of Boston Scientific Corporation. (Appeal
Br. 3.)
Appeal 2016-005693
Application 13/716,704
12.) The invention at issue in this appeal relates to “a lead anchoring
system with limited movement of an anchoring device along a lead.” {Id. 1
l.2) Figure 3 of the Specification is reproduced below:
Fig, 3
(Spec. Fig. 3.) Figure 3 of the Specification shows a longitudinal cross-
sectional view of an anchoring system. {Id. H 27, 43.) As shown in the
figure, the Specification describes an anchoring device 22 having a lumen 46
adapted to receive a lead 24 and at least one protrusion 48 extending into the
lumen, where the lead has a portion 50 having a length corresponding to a
distance A and a reduced outer diameter as compared to remainder portions
of the lead. {Id. H 36, 42, 47.) The Specification explains that in such an
anchoring system the anchoring device can only move along the lead for a
distance A, because the ends 52 of the portions of the lead that do not have a
reduced diameter “act as physical hard stops” preventing further movement
as they come into contact with protrusion 48. (Id. 136.)
2 We refer to 11 of the Specification under the heading “Technical Field.”
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Application 13/716,704
Claims 1, 4—7, 10—15, and 18—20 are on appeal. Claim 1 is illustrative
and reproduced below with key limitations emphasized:
1. A medical system for implantation within a patient's
body, the medical system comprising:
an implantable medical device;
a lead including an insulating sheath, the lead having a
proximal end, a distal end and an intermediate portion
located between the proximal and distal ends, wherein
the proximal end has a connector connecting the lead to
the implantable medical device, and the intermediate
portion includes a portion of the sheath having a
reduced outer diameter compared to an outer diameter
of a remainder of the intermediate portion of the sheath
at opposite ends of the reduced diameter portion-, and
an anchoring device for anchoring the lead within the patient's
body, the anchoring device positioned over the insulating
sheath, the anchoring device comprising:
a sleeve having a first end, a second end, an intermediate
portion located between the first end and the
second end, the first and second ends axially
moveable along the lead;
at least one suturing structure located on an outer surface
of the sleeve;
an inner lumen extending through the sleeve that
accommodates the reduced outer diameter portion
of the sheath, the inner lumen having a diameter
that is greater than the outer diameter of the
reminder of the intermediate portion of the lead;
and
a protrusion protruding inward into the inner lumen such
that axial movement of the protrusion along the
lead is limited to within the reduced outer diameter
portion of the sheath.
(Br. 13 (emphasis added).)
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Application 13/716,704
The Examiner rejects claims 1, 4—7, 10-15, and 18—20 under pre-AIA
35 U.S.C. § 103(a) as obvious over Sudam3 and Zarembo.4 (Final Act. 2.)
DISCUSSION
Issue
The Examiner finds that Sudam
discloses the invention substantially as claimed including that axial
movement of the sleeve along the lead is limited to within the reduced
outer diameter portion of the lead, but does not expressly disclose that
the anchoring sleeve includes at least one protrusion that extends
inward into the inner lumen to limit the axial movement.
(Final Act. 3.) However, the Examiner finds that, “[i]n the same field of
endeavor, Zarembo . . . teaches that it is known to use an inwardly facing
circumferential protrusion ... to retain a fixation suture sleeve in place at a
desired location along a lead body . . . with a reduced diameter . . . .” (Id.)
The Examiner concludes that
[i]t would have been obvious to one having ordinary skill in the art at
the time the invention was made to modify the system and method as
taught by Sudam . . . , with the inward protrusion as taught by . . .
Zarembo . . ., since such a modification would provide the predictable
results of retaining the sleeve structure in place axially at the desired
location of the lead body and preventing axial movement of the sleeve
beyond the reduced diameter portion of the lead.
(Id. at 3 4.)
Appellants contend that the cited prior art does not teach or suggest “a
lead having an intermediate portion including a portion of the sheath having
a reduced outer diameter compared to an outer diameter of a remainder of
3 Sudam et al., US 2012/0029335 Al, published Feb. 2, 2012.
4 Zarembo et al., US 2008/0262588 Al, published Oct. 23, 2008.
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Application 13/716,704
the intermediate portion of the sheath at opposite ends of the reduced
diameter portion.” (Br. 8.)
The issue with respect to this rejection is whether the evidence of
record supports the Examiner’s conclusion that the prior art teaches or
suggests the limitation of “a lead having an intermediate portion including a
portion of the sheath having a reduced outer diameter compared to an outer
diameter of a remainder of the intermediate portion of the sheath at opposite
ends of the reduced diameter portion.”
Findings of Fact
1. Sudam relates to designs for implantable leads that have
fixation structures, such as suture sleeves, to keep leads at a desired location
after implant. (Sudam Abstract.)
2. Sudam teaches that “[t]he lead . . . carries electrical conductors
that allow electrical coupling of electronics in the canister ... to the
electrodes .... Conductors in the lead . . . may take the form of wires of
any suitable conductive material and construction . . . , which may have
separate coating or sheathing for anticorrosive, insulative and/or protective
reasons.” {Id. 126; see also id. 192 (lead may be coated).)
3. Figure 3 A of Sudam is reproduced below:
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Application 13/716,704
(Id. at Fig. 3A.) Sudani’s Figure 3A “illustrates an embodiment of a lead
with a moveable fixation apparatus located between two distal electrodes
thereof.” (Id. 130.)
4. Referring to Figure 3 A, Sudam teaches that
[t]he lead 60 is shown with a distal electrode at 62 and a more
proximal electrode shown at 64. ... [T]he proximal electrode 64
may optionally include a distal “stopper” 64A, shown as a thickened
ring for the example. The stopper 64A may be part of the electrode
64 and may be conductive or, alternatively, the stopper 64A can be a
non-conductive element. A suture sleeve 66 is shown disposed
between the distal electrode 62 and the stopper 64A. The suture
sleeve 66 may be fixed or slidable on the lead 60 between the stopper
64A and the distal electrode 62.
... In some examples, the stopper 64A may be omitted. For
example,. . . electrode 64 may be of sufficient diameter to block
passage of a slidable suture sleeve 66, allowing the stopper 64A to be
omitted. . . .
In some examples, the area proximal of the stopper 64A is
referred to as a suture sleeve receiving area. In some examples, the
area between the distal electrode 62 and electrode 64 is referred to as
the suture sleeve receiving area. In some examples,... the area distal
of electrode 64 is of reduced diameter to receive the suture sleeve.
For example, two separate pieces of tubing may be used, or a single
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Application 13/716,704
multi-lumen element may be cut, compressed or ground to a reduced
diameter distal of electrode 64.
{Id. 1130-32.)
5. Sudam teaches that “[t]he suture sleeve 66 . . . includ[es] a bore
. . ., which is sized to receive at least a portion of the lead.” {Id. 133.)
6. Sudam teaches that “[a] number of leaflets ... are provided on
the suture sleeve 66. Some leaflets ... are shown as including suture holes.”
{Id. 136.)
7. Sudam teaches that, “[i]n some embodiments, it is desirable to
have the suture sleeve 66 moveable relative to the rest of the lead 60 in order
to create some ‘play’ or strain relief in the placement of the system.” {Id.
135.)
8. Sudam claims a
[a] combination suture sleeve and implantable lead electrode for . . .
implantation in a patient. . ., the lead electrode comprising: a distal
region having at least one electrode and a distal tip; and . . .
characterized by the region of the lead electrode including a suture
sleeve receiving area having an outer diameter sized to movably fit in
the bore of the suture sleeve and a stopper at a distal end of the suture
sleeve receiving area to prevent the suture sleeve from sliding distally
beyond the suture sleeve receiving area during use.
{Id. at claim 8.) Sudam further claims the combination above wherein the
suture sleeve receiving area extends between first and second electrodes
located in the distal region of the combination, wherein the first electrode is
disposed at the distal tip and
includes a proximal end which forms the stopper by virtue of greater
outer diameter than a portion of the suture sleeve receiving area
adjacent thereto, and wherein the second electrode includes a distal
end which forms a proximal stop preventing the suture sleeve from
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Application 13/716,704
moving proximal thereof, thus bounding movement of the suture
sleeve during use between the first and second electrodes.
(Id. at claims 10 & 11.)
Analysis
Except as otherwise noted, we agree with and adopt the Examiner’s
analysis that the cited prior art suggests the limitation of “a lead having an
intermediate portion including a portion of the sheath having a reduced outer
diameter compared to an outer diameter of a remainder of the intermediate
portion of the sheath at opposite ends of the reduced diameter portion.”
(Final Act. 2—6; Advisory Act. 2; Ans. 2—5; FF1—FF8.) We address
Appellants’ arguments below. To facilitate our discussion, Sudani’s Figure
3 A is reproduced again belo w:
3A
(Sudam Fig. 3A; see also FF3.) Sudam’s Figure 3A “illustrates an
embodiment of a lead with a moveable fixation apparatus located between
two distal electrodes thereof.” (FF3.)
Appellants first contend that Sudam “discloses a reduced outer
diameter portion only at the distal end of the lead 60, not at an intermediate
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Application 13/716,704
portion between the proximal and distal ends.” (Br. 9.) Appellants therefore
contend that Sudam only suggests a portion of the lead’s insulating sheath
having a reduced outer diameter as compared to the diameter of the sheath at
the proximal end of the reduced diameter portion, rather than “at opposite
ends of the reduced diameter portion” (i.e., at both the distal and proximal
ends of the reduced diameter portion). {Id. (emphasis omitted)).
We are not persuaded. Sudam specifically teaches an embodiment in
which the area distal of electrode 64 is of reduced diameter to receive the
suture sleeve. (FF3, FF4.) However, Sudam also teaches that in some
embodiments it is the area between the distal electrode 62 and electrode 64
that is the suture sleeve receiving area while in other embodiments it is the
area proximal of the stopper 64A that is the suture sleeve receiving area.
(Id.; see also Advisory Act. 2.) Sudam likewise claims a lead assembly
having a stopper at the distal end of the suture sleeve receiving area to
prevent the sleeve from sliding distally beyond the suture sleeve receiving
area during use. (FF8.) We therefore find that Sudam suggests reducing the
diameter of a lead at an intermediate portion as well as at the distal end of
the lead.
Appellants contend that “[tjhere is nothing in [Sudam] to suggest that
the sheath returns to a larger diameter distal of the suture sleeve receiving
area.” (Br. 9.) Appellants contend that, in fact, a skilled artisan
would have no reason [to] add a non-reduced diameter portion
of the sheath at the distal end [of the suture sleeve receiving
area], at least because Sudam teaches that the function of
limiting the travel of the suture sleeve 66 at the distal end is
already performed by the distal electrode 62.
(Br. 10.) Appellants further contend that the greater diameter of electrode
62 as compared to the diameter of the lead / lead sheath at the suture sleeve
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Application 13/716,704
receiving area does not meet the claim limitation at issue because the
relevant diameters are that of portions of the insulating sheath surrounding
the lead, not “components attached to the sheath, such as the distal electrode
62 as disclosed in [Sudam].” (Id.)
We are not persuaded. As an initial matter, Sudam teaches that the
reason for reducing the diameter of a portion of the lead is to “receive the
suture sleeve.” (FF4.) Thus, Sudam suggests that the diameter of the lead
sheath need not be reduced outside of the suture sleeve receiving area.
Indeed, Sudam suggests embodiments in which a stopper is disposed at the
distal end of the suture sleeve receiving area (FF8), as well as embodiments
in which a stopper is disposed at the proximal end of the area (FF3, FF4).
To the extent Appellants argue that the increase in the diameter of the
lead assembly at the ends of the suture sleeve receiving area resulting from
Sudam’s stopper does not meet the claim limitation, we are not persuaded.
Appellants have not persuasively argued that stoppers are only extra
“components attached to the sheath” rather than part of the lead or the sheath
such that the stoppers increase the outer diameter of the sheath surrounding
the lead. Sudam teaches, for example, that the stopper may be a
nonconductive element rather than “part of the electrode . . . and . . .
conductive.” (FF4.) Sudam further teaches that the function of the stopper
is to increase the diameter of the lead assembly as a whole at the ends of the
suture receiving area so as to block passage of a slidable suture sleeve. (Id.)
It would be obvious to a skilled artisan to substitute a known equivalent
structure (sheath with an increased outer diameter) for another (a stopper).
Cf. In re Omeprazole Patent Litigation, 483 F.3d 1364, 1374 (Fed. Cir.
2007) (“[T]his court finds no . . . error in [the] conclusion that it would have
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Application 13/716,704
been obvious to one skilled in the art to substitute one ARC [alkaline
reactive compound] for another.”).
For the same reasons, we note but are not persuaded by Appellants’
contention that the claimed invention are advantageous in that “[t]he
embodiments as claimed . . . may be effectively applied anywhere along the
lead” and “eliminate the need for extra components required in [Sudam]
(e.g., stoppers) in limiting movement of suture sleeve.” (Br. 10—11.) That
is, we find that Sudam also suggests locating suture sleeve receiving areas
other than at the distal end of the lead, and Appellants have not persuasively
explained why Sudam’s stoppers—which may be a thickened ring of
nonconductive element that increases the outer diameter of the lead
assembly as compared to the diameter of the suture sleeve receiving area—
does not meet or render obvious the disputed limitation.
Finally, Appellants contend that other cited references do not cure the
deficiency of Sudam.5 (Br. 11.) We are not persuaded because, as discussed
above, we find that Sudam renders obvious the disputed limitation.
Accordingly, we affirm the Examiner’s rejection of claim 1. Claims
4—7, 10-15, and 18—20, which are not separately argued, fall with claim 1.
37C.F.R. §41.37(c)(l)(iv).
5 Appellants and the Examiner both discuss Soltis et al., US 2007/0282414
Al, published Dec. 6, 2007 (“Soltis”). (Br. 11; Ans. 4—5.) Because Soltis
was not applied in the rejection on appeal before us (Ans. 4) and because we
find Sudam and Zarembo render claim 1 obvious, we do not rely on Soltis in
our affirmance and do not express an opinion or adopt the Examiner’s
analysis on whether Soltis further render claim 1 obvious.
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SUMMARY
For the reasons above, we affirm the Examiner’s decision rejecting
claims 1, 4—7, 10-15, and 18—20.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
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