Ex Parte Flowers et al

Patent Trials and Appeals Board

Mar 21, 2019

15206073 - (D) (P.T.A.B. Mar. 21, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
15/206,073 07/08/2016
50638 7590 03/25/2019
Boston Scientific Neuromodulation Corp.
c/o Lowe Graham Jones
701 Fifth Avenue
Suite 4800
Seattle, WA 98104
FIRST NAMED INVENTOR
Matthew Braden Flowers
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
BSNC-1-444.1 9117
EXAMINER
D ABREU, MICHAEL JOSEPH
ART UNIT PAPER NUMBER
3792
NOTIFICATION DATE DELIVERY MODE
03/25/2019 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):
patentdocketing@lowegrahamjones.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MATTHEW BRADEN FLOWERS and
JOHN MICHAEL BARKER1
Appeal2018-000798
Application 15/206,073
Technology Center 3700
Before MICHELLE R. OSINSKI, JILL D. HILL, and LEE L. STEPINA,
Administrative Patent Judges.
OSINSKI, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellant appeals under 35 U.S.C. § 134(a) from the Examiner's
decision rejecting claims 1-20, which are all of the pending claims. We
have jurisdiction under 35 U.S.C. § 6(b ).
We REVERSE.
1 Boston Scientific Neuromodulation Corporation ("Appellant") is the
Applicant as provided in 3 7 C.F .R. § 1.46 and is identified as the real party
in interest. Appeal Br. 2.
Appeal2018-000798
Application 15/206,073
THE CLAIMED SUBJECT MATTER
Claim 1, the sole independent claim, is reproduced below.
1. An implantable electrical lead, comprising:
a lead body having a proximal end and a distal end;
a plurality of contacts disposed along the distal end of the
lead body;
a plurality of terminals disposed along the proximal end of
the lead body;
a plurality of conductors axially extending within the lead
body and coupling the contacts to the terminals; and
a stiffening tube disposed within the proximal end of the
lead body and beneath at least one of the terminals, wherein the
stiffening tube defines a lumen extending through the stiffening
tube and the stiffening tube terminates proximal to all of the
contacts.
EVIDENCE
The Examiner relied on the following evidence in rejecting the claims
on appeal:
Borkan
Smits
Cross
us 4,379,462
US 6,549,812 Bl
US 2006/0089697 Al
THE REJECTIONS
Apr. 12, 1983
Apr. 15, 2003
Apr. 27, 2006
I. Claims 1-7 and 12-20 stand rejected under 35 U.S.C. § 103 as
unpatentable over Borkan and Smits. Final Act. 3--4.
II. Claims 8-11 stand rejected under 35 U.S.C. § I03(a) as
unpatentable over Borkan, Smits, and Cross. Id. at 5.
OPINION
Rejection I
Claims 1-3, 5-7, 14, 15, 17, 19, and 20
The Examiner finds that Borkan teaches, among other things:
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Application 15/206,073
a stiffening tube disposed within the proximal end of the lead
body and beneath at least one of the terminals [(e.g. Fig. 5, #62
etc.)], wherein the stiffening tube terminates proximal to all of
the contacts [(e.g., Fig 5, #20 etc.)] (e.g.[,] Fig. 1, #39; where it
is noted that the stiffening wire is described as running the entire
length of the electrode assembly or a portion thereof and
therefore would meet the claimed limitations - e.g.[,] [c]ol[.] 2,
lines 65-68).
Final Act. 3.
Appellant argues that Borkan's "broad, generic teaching" that simply
discloses that the stiffening member may run the entire length of the
electrode assembly or along a portion thereof does not teach "the specific
position ('beneath at least one of the terminals and terminating proximal to
all of the contacts') of the stiffening tube recited in claim 1." Appeal Br. 5.
Appellant further argues that Borkan' s stiffening member running the entire
length of the electrode assembly "does not teach or suggest the present
stiffening tube which must terminate proximal to all of the contacts." Id. at
6.
Appellant's Specification describes that "the proximal end [of a
stimulation lead should] be as stiff as reasonably possible to provide the
necessary columnar strength for the proximal end to overcome the frictional
forces exerted on the lead when inserted into the connector," but "[a]t the
same time, it is important that the remaining portion of the lead be as
flexible as reasonably possible, so as to minimize the possibility of tissue
trauma/irritation to the epidural and surrounding tissues." Spec. ,r 11. To
achieve this objective, the Specification describes the electrical lead
including "a stiffening tube extending within the proximal end of the lead
body from a point proximal to the terminal to a point distal to the terminal
and proximal to the electrode." Id. ,r 15.
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Appeal2018-000798
Application 15/206,073
The Patent and Trademark Office gives claims their broadest
reasonable construction "in light of the [S]pecification as it would be
interpreted by one of ordinary skill in the art." In re Am. Acad. of Sci. Tech
Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004). In light of the foregoing
description in the Specification, we determine that one of ordinary skill in
the art would understand "a stiffening tube disposed within the proximal end
of the lead body and ... [that] terminates proximal to all of the contacts," as
recited in claim 1, to mean a stiffening tube that originates in the proximal
end of the lead and terminates proximal to the contacts ( or electrodes) in the
distal end of the lead (i.e., does not extend in the distal end of the lead). It
would be unreasonable to consider the claim to cover a stiffening tube that
originates in the distal end of a lead and terminates at the proximal-most end
of the electrode assembly (so as to terminate proximal to not only all of the
contacts at the distal end of the lead body, but indeed also to all of the
terminals at the proximal end of the lead body). Such a stiffening tube
would not provide for the desired objective of having the proximal end of a
lead be stiff, while allowing the remaining portion of the lead ( e.g., distal
end) to be as flexible as possible.
With this broadest reasonable construction in mind, we consider
Borkan' s disclosure. Borkan describes a catheter electrode "having four
equally spaced electrodes along the exterior of the sheath" at the distal end
and "fo[u]r equally spaced terminals 58, 60, 62, and 64 mounted to the
exterior of the sheath 12 [ at the proximal end] in the same manner as the
electrodes at the distal end." Borkan 4:30-37 (boldface omitted); Fig. 5.
Borkan also describes that "[t]his embodiment includes a stiffening wire
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Appeal2018-000798
Application 15/206,073
which is a permanent part of the electrode assembly and which may run all
or a portion of the length of the electrode assembly." Id. at 4:40-43.
The Examiner erred in finding that that Borkan' s stiffening member
that runs the length of the electrode assembly discloses a stiffening tube
disposed within the proximal end of the lead body and that "terminates
proximal to all of the contacts" under the broadest reasonable construction.
Borkan' s stiffening member cannot be considered to originate in the
proximal end of the lead and terminate proximal to the contacts ( or
electrodes) in the distal end of the lead. When considering Borkan' s
stiffening member to originate in the proximal end of the lead, the stiffening
member terminates distal to the contacts (i.e., at the distal-most end of the
lead).
On the other hand, if considering Borkan' s stiffening member to
terminate proximal to the contacts, the stiffening member must be
considered to originate in the distal end of the lead. Only when considering
Borkan' s stiffening member to originate in the distal end of the lead, the
stiffening member terminates proximal to both the contacts and the terminals
(i.e., at the proximal-most end of the lead). In this case, the entire lead,
rather than just the proximal end, will have increased stiffness and decreased
flexibility. Accordingly, Borkan fails to disclose a "a stiffening tube
disposed within the proximal end of the lead body and ... [that] terminates
proximal to all of the contacts," as claimed, when the claim is given its
broadest reasonable interpretation.
The Examiner's rejection is thus based on an erroneous finding as to
the scope and content of Borkan when considering the broadest reasonable
interpretation of claim 1.
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Application 15/206,073
In the Answer, the Examiner states:
the [E]xaminer maintains the position that the prior art ofBorkan
obviates the claimed wire being disposed within the proximal
end of the lead body . . . and terminating proximal to all of the
contacts, as it is clear that the wire length may be adjusted to a
plurality of lengths and locations based on the required
application and stiffness requirements.
Ans. 3. To the extent that the Examiner may be taking an alternative
position in the Answer based on the purported obviousness of modifying
Borkan so as to have the stiffening member extend along a portion of the
assembly only in the proximal end of the assembly, we do not find this
proposed modification of Borkan to be adequately supported by articulated
reasoning based on rational underpinnings.
As noted by Appellant, Borkan teaches a "stiffening wire [that] may
be provided for either the total length or just for the length of the tip portion
of the catheter electrode assembly to improve steerability and aid
placement." Reply Br. 4 (quoting Borkan, 2:25-29). As also noted by
Appellant, Borkan teaches that the stiffening wire may run the entire length
or "just a portion thereof extending from the distal end approximately 15
centimeters [to] allow[] flexibility of the catheter assembly at the exit point
from the spinal column." Id. at 4--5 (citing Borkan 2:65-3:2). Appellant
thus persuasively argues that "Borkan[] either extends a) along the entire
length of the lead or b) along the distal portion of the lead." Id. at 5. The
Examiner has not adequately explained what would have led one of ordinary
skill in the art to have Borkan's stiffening wire extend only in the proximal
region and terminate proximal to the contacts (i.e., electrodes) of the distal
end.
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Application 15/206,073
For the foregoing reasons, we do not sustain the Examiner's rejection
of claim 1, nor claims 2-7 and 12-20 which depend therefrom, under 35
U.S.C. § 103 as unpatentable over Borkan and Smits.
Rejection II
The rejection of claims 8-10, which depend from independent
claim 1, relies on the Examiner's erroneous finding that Borkan discloses a
stiffening tube disposed within the proximal end of the lead body and that
terminates proximal to all of the contacts. Final Act. 3, 5. The Examiner
does not explain how Cross cures this underlying deficiency. Accordingly,
for the reasons discussed above, we do not sustain the rejection of claims 8-
11 under 35 U.S.C. § 103 as unpatentable over Borkan, Smits, and Cross.
DECISION
The Examiner's decision to reject claims 1-7 and 12-20 under
35 U.S.C. § 103 as unpatentable over Borkan and Smits is reversed.
The Examiner's decision to reject claims 8-11 under 35 U.S.C. § 103
as unpatentable over Borkan, Smits, and Cross is reversed.
REVERSED
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