Ex Parte Pianca et al

Board of Patent Appeals and Interferences

Nov 16, 2010

11117814 (B.P.A.I. Nov. 16, 2010)

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.
11/117,814 04/29/2005 Anne M. Pianca 20334/0208385-US0 7909
50638 7590 11/16/2010
Boston Scientific Neuromodulation Corp.
c/o Frommer Lawrence & Haug LLP
745 Fifth Ave
NEW YORK, NY 10151
EXAMINER
BERTRAM, ERIC D
ART UNIT PAPER NUMBER
3766
MAIL DATE DELIVERY MODE
11/16/2010 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte ANNE M. PIANCA, JANUSZ A. KUZMA,
and CHULADATTA THENUWARA
____________

Appeal 2009-008735
Application 11/117,814
Technology Center 3700
____________

Before JOHN C. KERINS, STEFAN STAICOVICI, and
FRED A. SILVERBERG, Administrative Patent Judges.

STAICOVICI, Administrative Patent Judge.

DECISION ON APPEAL1

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.

Appeal 2009-008735
Application 11/117,814

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STATEMENT OF THE CASE
Anne Pianca et al. (Appellants) appeal under 35 U.S.C. § 134 from the
Examiner’s decision finally rejecting claims 38, 50, 55, 60, 61, and 64.
Claims 1-37 have been canceled. Claims 39-49, 51-54, 56-59, 62, 63, and
65 have been withdrawn from consideration by the Examiner. We have
jurisdiction over this appeal under 35 U.S.C. § 6.

THE INVENTION
Appellants’ invention relates to insertion and/or implantation steering
tools and methods used with implantable paddle-style electrodes in spinal
cord stimulation. Spec. [0002] and figs. 4A-4C.
Claim 38 is representative of the claimed invention and reads as
follows:
38. A system for implanting a paddle-style electrode in a
patient without an insertion needle, the system comprising:
a paddle-style electrode platform including an attachment
means, a back surface, an active surface carrying at least one
electrode contact and distal, proximal and side edge surfaces;
and an insertion tool to implant the paddle-style electrode
platform in the patient without using an insertion needle, the
insertion tool including a platform engager for engaging the
attachment means of the electrode platform to guide the
electrode platform during placement of the paddle style
electrode in the patient.

THE REJECTIONS
The Examiner relies upon the following as evidence of
unpatentability:
Kuzma US 6,522,932 B1 Feb. 18, 2003

Appeal 2009-008735
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Appellants seek review of the Examiner’s rejection of claims 38, 50,
55, 60, 61, and 64 under 35 U.S.C. § 102(b) as anticipated by Kuzma.

SUMMARY OF DECISION
We REVERSE.

OPINION
Independent claim 38 requires an insertion tool to implant a paddle-
style electrode platform in a patient “without using an insertion needle.” Br.,
Claims Appendix. Appellants argue that in contrast to the claimed invention
Kuzma teaches “implanting an electrode array using an insertion tool 50 that
is an insertion needle.” Br. 5. Br. 6. Pointing to column 7, lines 58-59 of
Kuzma, Appellants argue that Kuzma discloses that insertion tool 50 is
“often simply called a needle.” Br. 6. Appellants further argue that,
“[w]hether or not there is a ‘sharp tip’, one of ordinary skill in the art would
recognize that the insertion tool 50 (or hollow tube 50) is an insertion
needle.” Br. 7. In response, the Examiner first found that Kuzma discloses
needle 30 as preferably having “a sharp distal tip.” Ans. 4. The Examiner
further found that “insertion tool 50 has a non-pointed tip, and as such,
would not be considered an insertion needle based on the definition provided
by Kuzma to describe needle 30.” In other words, the Examiner appears to
consider a “needle” an object that must have a “pointed tip.” See Ans. 4.
At the outset, we note that when construing claim terminology in the
United States Patent and Trademark Office, claims are to be given their
broadest reasonable interpretation consistent with the specification, reading
claim language in light of the specification as it would be interpreted by one
Appeal 2009-008735
Application 11/117,814

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of ordinary skill in the art. In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d
1359, 1364 (Fed. Cir. 2004). In this case, Appellants’ Specification does not
expressly define the term “needle” or otherwise indicate that this term is
used in a manner other than its ordinary and customary meaning.
Accordingly, we construe the term “needle” in accordance with its ordinary
and customary meaning. We find that an ordinary and customary meaning
of the term “needle” that is most consistent with the Specification and the
understanding of those of ordinary skill in the art is “1 c (1) : a slender
hollow instrument for introducing material into or removing material from
the body parenterally.” MERRIAM WEBSTER’S COLLEGIATE DICTIONARY
(10th Ed. 1997). As such, we construe the term “needle,” as applied to an
insertion tool, to mean a slender hollow instrument for introducing material
into the body parenterally.
It is our finding that Kuzma teaches an insertion tool 50 and an
electrode array 40 that is inserted into insertion tool 50 in order to be
implanted. Kuzma, col. 6, ll. 22-23 and figs. 5 and 6. Kuzma further teaches
that electrode array 40 is deployed from insertion tool 50 into position, e.g.,
in the spinal cord cavity, by first inserting the insertion tool 50 into tissue
and then pushing electrode array 40 through the insertion tool 50. Kuzma,
col. 7, ll. 54-67. See also, Kuzma, col. 6, ll. 59-62. Furthermore, when
viewing insertion tool 50 of Kuzma, as presented in figures 11A and 11B of
Kuzma, the insertion tool 50 appears as a slender hollow instrument.
Accordingly, because insertion tool 50 of Kuzma is inserted into tissue and
allows electrode array 40 to pass through, we find that insertion tool 50 of
Kuzma is a slender hollow instrument for introducing material into the body
parenterally, and hence constitutes an “insertion needle”.
Appeal 2009-008735
Application 11/117,814

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As an alternative interpretation of the teachings of Kuzma, the
Examiner contends that even if the insertion tool 50 of Kuzma is considered
a “needle,” Kuzma also teaches that stylet 54, of Figure 8B, may be used to
implant the electrode array in a patient without the use of insertion tool 50.
Ans. 4. Appellants argue that Kuzma does not teach or suggest that “paddle
electrode array 40 is insertable using only a stylet and not an insertion tool.”
Reply Br. 5.
We find that Appellants have the better argument. It is our finding
that Kuzma specifically teaches that steering stylet 54 is used to guide the
insertion process. Kuzma, col. 7, ll. 27-30. Since steering stylet 54 is a
slender solid instrument (see Figure 8B of Kuzma) and electrode array 40 is
inserted into and deployed from the insertion device into position, e.g., in the
spinal cord cavity, we find that steering stylet 54 cannot perform the
function of having electrode array 40 inserted into it and deployed from it as
is required of the insertion device disclosed in Kuzma. Hence, steering
stylet 54 cannot be considered an insertion device as disclosed by Kuzma for
inserting paddle electrode array 40.
In conclusion, because we find that insertion tool 50 of Kuzma is an
“insertion needle” and steering stylet 54 of Kuzma is a guide and not an
insertion device for inserting paddle electrode array 40, Kuzma does not
teach all the elements of independent claim 38. Accordingly, the rejection
of independent claim 38 and its dependent claims 50, 55, and 60 under 35
U.S.C. § 102(b) as anticipated by Kuzma, cannot be sustained.
With respect to claims 61 and 64, although drawn to a method, claims
61 and 64 incorporate the system disclosed in claim 38. Thus, method claims
61 and 64 contain all of the limitations of claim 38. Accordingly, the
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Application 11/117,814

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rejection of claims 61 and 64 under 35 U.S.C. § 102(b) as anticipated by
Kuzma likewise cannot be sustained.

DECISION
The Examiner’s decision to reject claims 38, 50, 55, 60, 61, and 64 is
reversed.

REVERSED

MP

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