Ex Parte Bonde et al

Patent Trial and Appeal Board

Dec 4, 2013

11413354 (P.T.A.B. Dec. 4, 2013)

UNITED STATES PATENT AND TRADEMARKOFFICE
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.
11/413,354 04/28/2006 Eric H. Bonde M190.195.101/P0024854.00 1467
25281 7590 12/04/2013
DICKE, BILLIG & CZAJA
FIFTH STREET TOWERS
100 SOUTH FIFTH STREET, SUITE 2250
MINNEAPOLIS, MN 55402
EXAMINER
KIMBALL, JEREMIAH T
ART UNIT PAPER NUMBER
3766
MAIL DATE DELIVERY MODE
12/04/2013 PAPER
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.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte ERIC H. BONDE, ERIC M. STETZ, CAROLE A. TRONNES, and
JAMES T. HENRY1
____________

Appeal 2012-000617
Application 11/413,354
Technology Center 3700
____________

Before DONALD E. ADAMS, ERIC GRIMES, and TINA E. HULSE,
Administrative Patent Judges.

HULSE, Administrative Patent Judge

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims relating to
temporarily implanted neurostimulation devices. The Examiner rejected all
claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
Claims 1-22 and 25-29 are on appeal. (App. Br. 3.)

1 Appellants identify the Real Party in Interest as Medtronic, Inc. (App.
Br. 3.)
Appeal 2012-000617
Application 11/413,354

2
Claim 1 is illustrative and is reproduced below:
1. A temporarily implantable medical electrical lead for
applying electrical stimulation to bodily tissue of a patient from
a power source located external the patient, the lead adapted to
be introduced through, and released from, a needle having a
lumen defining a diameter of not greater than 0.05 inch, the
lead comprising:
a lead body including:
a wire defining a distal portion terminating at a distal end
and a proximal portion terminating at a proximal end,
the wire forming a wound coil along at least the distal
portion, and the proximal end adapted to be
electrically coupled to a power source for performing
a peripheral nerve evaluation on a sacral nerve,
an electrically non-conductive material covering a
section of the distal portion, wherein the non-
conductive material terminates proximal the distal end
to define an uncovered distal region of the wire coil,
wherein at least a segment of the uncovered distal region
serves as a lead electrode; and
a fixation assembly coupled to the uncovered distal region,
the fixation assembly including at least one fixation
member;
wherein the fixation assembly is configured and
assembled to the wire coil to be transitionable
between a first, contracted state in which a free end of
the fixation member lies directly against and contacts
the uncovered distal region of the wire coil such that
the fixation member is spaced apart from the
electrically non-conductive material so that at least a
portion of the uncovered distal region is exteriorly
exposed and a second, expanded state, a radially
outward extension of the fixation member relative to
the wire coil being greater in the expanded state than
in the contracted state to inhibit axial dislodgement of
Appeal 2012-000617
Application 11/413,354

3
the lead body such that, upon finishing performance
of the peripheral nerve evaluation, the lead is removed
by applying a pulling force on the proximal end of the
lead.
The claims stand rejected under 35 U.S.C. § 103(a) as follows:
I. Claims 1-10, 12-14, 17, 19-22, and 25-28 over Duysens2 in
view of Citron3 and Mrva.4 (Ans. 3-11.)
II. Claim 11 over Duysens in view of Citron, Mrva, and Chastain.5
(Id. at 12-13.)
III. Claims 15, 16, and 29 over Duysens in view of Citron, Mrva,
and Carson.6 (Id. at 13-14.)
IV. Claim 18 over Duysens in view of Citron, Mrva, and Stolz.7 (Id.
at 14.)
DISCUSSION
The Examiner rejected each of the claims as obvious over Duysens,
Citron, and at least one other reference. The Examiner found that Duysens
teaches a neurostimulation device for the sacral nerve, but did not disclose
an expandable fixation assembly, according to the claims. The Examiner
found that Citron discloses the expandable fixation assembly recited in the
claims. Appellants assert that Citron does not disclose a fixation assembly
in which, in the contracted state, the “free end of the fixation member lies
directly against and contacts the uncovered distal region such that the

2 Duysens et al., US 6,104,960, issued August 15, 2000.
3 Citron et al., US 3,902,501, issued September 2, 1975.
4 Mrva et al., US 2006/0004429 A1, published January 5, 2006.
5 Chastain et al., US 6,178,356 B1, issued January 23, 2001.
6 Carson, US 5,545,206, issued August 13, 1996.
7 Stolz et al., US 6,477,427 B1, issued November 5, 2002.
App
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/413,354
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.” (Citron
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l
Appeal 2012-000617
Application 11/413,354

6
Figure 1 depicts a preferred embodiment of Citron’s endocardial
electrode.
9. Figure 1 illustrates:
A body member 10 terminating at an exposed electrically
conductive tip 11 and a plurality of tines 12 extending at an
acute angle. . . . The tines 12 are of a pliant material which is
generally inert to body fluids; silicone rubber or polyurethane,
for example. The tines 12 may be attached to the body member
10 in any convenient manner. For example, the tines may
extend from, and be unitary with, a disc 13 which disc is held in
position between the body member 10 and tip 11. Alternatively,
the member 13 may be in the form of a ring which lies over
either the body member 10 or tip 11 and is adhered thereto in
any convenient manner. The tines 12 may take any angle with
the body member 10, their purpose being to cooperate with the
body tissue . . . .
(Citron, col. 2, l. 67 – col. 3, l. 17.)
10. Citron teaches that “[a] plurality of pliant non-conductive tines
are provided at the tip of the electrode to cooperate with the heart tissue . . .
to maintain the electrode tip in electrical contact with the heart tissue while
allowing a removal of the electrode should that prove necessary.” (Id. at col.
2, ll. 21-26.)

Analysis
There are four obviousness rejections of the claims, but each relies, in
relevant part, on the Examiner’s proposed combination of Duysens and
Citron. We will therefore discuss the rejections together and, specifically,
this combination of references.
Both Duysens and Citron disclose medical electrical leads. (FF 1, FF
6.) Appellants assert that Duysens does not teach using an expandable
Appeal 2012-000617
Application 11/413,354

7
fixation member and that Citron does not teach a fixation member lying
against an uncovered distal region. (App. Br. 9.) The Examiner found that
one of ordinary skill in the art would recognize that one could improve upon
Duysens by placing Citron’s disk 13 and tines 12 (which Citron describes as
pliant) over Duysen’s electrode 103 to improve fixation while “carrying a
relatively small footprint along the surface of the electrode where exposed
electrode surface area is key to the invention.” (Ans. 15-16.) The Examiner
also found that it would have been obvious to maintain a space between the
tines 12 of Citron and the electrically nonconductive lead body 102 of
Duysens while the tines 12 are lying directly against and contacting the
uncovered distal electrode 103 of Duysens. (Id. at 16.) Specifically, the
Examiner reasoned that one of ordinary skill in the art would maintain a
space for three reasons: (1) without the space, some of the tines may overlap
with the lead body 102 and hinder the ease of passing the lead along the
needle 105 of Duysens; (2) maintaining the space would avoid degradation
of the insulated portion 102; and (3) if the tines are in contact with the
insulated portion 102, the tines may get stuck upon release from the needle.
(Id. at 17.)
In response, Appellants concede that “[i]f one were to position the
disc 13/tine 12 combination over the Duysens lead, one could envision space
between the tines and the covered region of Duysens.” (Reply Br. 2). But
Appellants then assert that Duysens teaches away from having an
expandable fixation assembly for two reasons. First, Appellants contend
that Duysens notes the lead “must be removed in a safe manner.” (Id. at 2.)
And second, Duysens discloses “providing strain relief on the lead such that
Appeal 2012-000617
Application 11/413,354

8
a pulling force would not remove the alleged modified lead of
Duysens/Citron.” (Id.)
We agree with the Examiner and find that the preponderance of the
evidence of record supports modifying Duysens’s electrode 103 with
Citron’s disk 13 and tines 12. Citron teaches adhering the member 13 and
tines 12 to the electrically conductive tip 11. (FF 9.) We find the
Examiner’s conclusion persuasive that one of skill in the art would combine
Duysens and Citron to improve fixation while “carrying a relatively small
footprint along the surface of the electrode where exposed electrode surface
area is key to the invention.” (Ans. 15-16.)
While neither Citron nor Duysens expressly describes a space
between the contracted tines 12 and the insulated lead body 102, we agree
with the Examiner that including such a space would have been obvious
given the limited design options of having a space or not having a space.
Moreover, we find reasonable the Examiner’s explanation as to why having
a space would be preferable to one of ordinary skill in the art. (See id. at 16-
17.) The Examiner’s reliance on common sense and design needs to
conclude the claims are obvious was not in error. See KSR Int’l Co. v.
Teleflex Inc., 550 U.S. 398, 421 (2007) (“When there is a design need . . . to
solve a problem and there are a finite number of identified, predictable
solutions, a person of ordinary skill has good reason to pursue the known
options within his or her technical grasp. If this leads to the anticipated
success, it is likely the product not of innovation but of ordinary skill and
common sense.”).
Appeal 2012-000617
Application 11/413,354

9
Furthermore, we do not find Appellants’ teaching away argument
persuasive. That Duysens notes the lead “must be removed in a smooth
manner” (FF 3) does not teach away from Citron, which teaches that its
pliant tines “allow[] the removal of the electrode.” (FF 10.) Moreover,
Duysens teaches that the closely wound coil of the lead body and electrode
permit strain relief so that any pulling on the outside of the lead “will not be
automatically translated to the electrode.” (FF 4-5.) It is unclear how
permitting such strain relief teaches away from an expandable fixation
assembly, particularly when Appellants’ own Specification discloses this
same feature (FF 6). Thus, we find that neither of these statements in
Duysens would discourage one of ordinary skill in the art from combining
Duysens and Citron. See In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994)
(“A reference may be said to teach away when a person of ordinary skill,
upon reading the reference, would be discouraged from following the path
set out in the reference, or would be led in a direction divergent from the
path that was taken by the applicant.”).
We therefore find that Duysens does not teach away from an
expandable fixation assembly and that the preponderance of the evidence
supports the Examiner’s conclusion that one of ordinary skill in the art
would have found the claimed invention obvious in light of Duysens and
Citron and the other cited references.

Conclusions of Law
We affirm the Examiner’s rejection of claim 1 under 35 U.S.C. § 103
over Duysens, Citron, and Mrva. Because Appellants did not separately
Appeal 2012-000617
Application 11/413,354

10
argue claims 2-10, 12-14, 17, 19-22, and 25-28, we affirm the Examiner’s
rejection of these claims for the same reasons. 37 C.F.R. § 41.37(c)(1)(vii).
Because Appellants have waived any arguments based on Chastain, Carson,
or Stolz, we also affirm the rejections of claims 11, 15, 16, 18, and 29. See
Hyatt v. Dudas, 551 F.3d 1307, 1314 (Fed. Cir. 2008).

SUMMARY
We affirm all of the rejections on appeal.

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
tc