Ex Parte Bonde et al

Patent Trials and Appeals Board

Mar 27, 2014

11739982 - (D) (P.T.A.B. Mar. 27, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE PATENT TRIAL AND APPEAL BOARD
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Ex parte ERIC H. BONDE and MARTIN T. GERBER1
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Appeal 2011-012920
Application 11/739,982
Technology Center 3700
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Before TONI R. SCHEINER, MELANIE L. McCOLLUM, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

McCOLLUM, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to an
implant tool introduction method. The Examiner has rejected the claims as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse.

1 Appellants identify the real party in interest as Medtronic, Inc. (App.
Br. 3.)
Appeal 2011-012920
Application 11/739,982

2
STATEMENT OF THE CASE
Claims 1-15, 17-19, 22, and 23 are on appeal (App. Br. 3).2 Claim 1
is illustrative and reads as follows:
1. A method comprising:
introducing an implant tool into a patient, the implant tool comprising:
a malleable needle; and
a cannula disposed around at least a portion of the needle,
wherein the cannula comprises a shape memory material;
advancing the needle to a target tissue site in at least one of a head or
a neck of the patient and proximate to at least one of an occipital nerve or a
trigeminal nerve of the patient, wherein the needle defines a path through
tissue of the patient; and
withdrawing the needle from the path,
wherein the cannula remains at least partially within the path and
changes from a first shape to a second shape after the needle is removed.
Claims 1, 8, 11, 14, 15, 17-19, 22, and 23 stand rejected under
35 U.S.C. § 103(a) as obvious over Tadlock (US 6,978,180 B2, Dec. 20,
2005) in view of Zaddem et al. (US 2006/0058575 A1, Mar. 16, 2006)
(Ans. 5).
Claims 2, 7, 9, 10, 12, and 13 stand rejected under 35 U.S.C. § 103(a)
as obvious over Tadlock in view of Zaddem and Chandran et al.
(US 2005/0159797 A1, Jul. 21, 2005) (Ans. 7).
Claims 3-6 stand rejected under 35 U.S.C. § 103(a) as obvious over
Tadlock in view of Zaddem and Yeung et al. (US 2004/0210209 A1,
Oct. 21, 2004) (Ans. 9).

2 Claims 16, 20, and 21 are also pending but have been indicated to be
allowable (App. Br. 3; Ans. 3).
Appeal 2011-012920
Application 11/739,982

3
The Examiner relies on Tadlock for disclosing
introducing an implant tool into a patient, comprising a
malleable needle and a cannula; advancing the needle to a target
tissue site in a head or neck of a patient an[d] proximate to the
occipital nerve and the trigeminal nerve . . . , wherein the needle
defines a path through a tissue of the patient; withdrawing the
needle from the path, wherein the cannula remains within the
path.
(Id. at 5.) In particular, the Examiner notes “that in at least one embodiment
(col. 17, lines 30-36; Figures 24A-24B) a needle is attached to a side of a
cannula, i.e., the cannula is disposed around at least a portion of the needle”
(id.).
The Examiner relies on Zaddem for disclosing “a cannula that
changes shape from a first to a second shape once a needle is withdrawn
from the cannula” and that the “cannula is constructed of shape memory
material” (id. at 5-6). The Examiner concludes that it would have been
obvious “to modify Tadlock’s epidural placement and stimulation with
Zaddem’s shape-changing cannula in order to aid placement and retrieval of
an implantable device within a patient” (id. at 6).
ISSUE
With regard to each ground of rejection, the following issue is
dispositive: Has the Examiner set forth a prima facie case that Tadlock and
Zaddem suggest a method comprising advancing a needle to a target tissue
site, wherein the needle defines a path through tissue of the patient, and
withdrawing the needle from the path, wherein the cannula remains at least
partially within the path?
Appeal 2011-012920
Application 11/739,982

4
FINDINGS OF FACT
1. Tadlock discloses a method for “implanting [an] electrical
stimulation system . . . into a person’s body . . . on, in, or near the brain
stem” (Tadlock, col. 8, ll. 14-18).
2. In particular, Tadlock discloses that “an insertion cannula or
introducer for electrical stimulation lead 14 may be inserted through [a] burr
hole into the brain at step 40 . . . . A cannula and electrical stimulation
lead 14 may be inserted together or lead 14 may be inserted through the
cannula after the cannula has been inserted.” (Id. at col. 8, ll. 24-30.)
3. Tadlock also discloses: “FIGS. 24A-24B illustrate an example
introducer 78 that includes a needle 180 attached to its side. Needle 180 is
deployed when stylet 182 compresses spring 184. Needle 180 may aid in
fixation of introducer 78 during insertion of an electrical stimulation
lead 14.” (Id. at col. 17, ll. 30-35.)
ANALYSIS
Appellants contend:
None of the portions of Tadlock cited by the Examiner . . .
disclose a method that includes introducing an implant tool
comprising a malleable needle and a cannula disposed around at
least a portion of the needle, advancing the needle to a target
tissue site, where the needle defines a path through tissue, and
withdrawing the needle, where the cannula remains at least
partially within the path.
(App. Br. 8.) In particular, Appellants argue that the “cited portion of
Tadlock fails to disclose that the introducer 78 (characterized as a cannula)
remains at least partially within the path defined by the needle 180, as
recited in claim 1” (Reply Br. 6). We agree.
Appeal 2011-012920
Application 11/739,982

5
The Examiner finds “that when the spring is released by the stylet
[182], the needle (180) is withdrawn (retracted) from the path of the cannula,
while the introducer [78] (cannula) remains within the path, as depicted in
Figures 24A-24B” (Ans. 10). However, we agree with Appellants that the
Examiner has not shown that the introducer 78 remains at least partially
within the path defined by needle 180 (Reply Br. 6).
CONCLUSION
The Examiner has not set forth a prima facie case that Tadlock and
Zaddem suggest a method comprising advancing a needle to a target tissue
site, wherein the needle defines a path through tissue of the patient, and
withdrawing the needle from the path, wherein the cannula remains at least
partially within the path. We therefore reverse the rejections of record.

REVERSED

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