Ex Parte Lamson et al

Patent Trial and Appeal Board

Jun 27, 2013

11838103 (P.T.A.B. Jun. 27, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte THEODORE CHARLES LAMSON, JOSHUA MAKOWER,
JOSEPH CATANESE III, JACQUELINE NERNEY WELCH,
AMRISH JAYPRAKASH WALKE, CLAUDE VIDAL,
RUSSELL J. REDMOND, and MICHAEL COLLINSON
____________

Appeal 2011-009046
Application 11/838,103
Technology Center 3700
____________

Before TONI R. SCHEINER, ULRIKE W. JENKS, and
GEORGIANNA W. BRADEN, Administrative Patent Judges.

JENKS, Administrative Patent Judge

DECISION ON APPEAL
This is an appeal
1
under 35 U.S.C. § 134 involving claims to an
introducer device for placing implants into the prostate. The Patent
Examiner has rejected the claims for obviousness. We have jurisdiction
under 35 U.S.C. § 6(b). We reverse.

1
Appellants state the Real Party-in-Interest is Neotract, Inc. (App. Br. 2).
Appeal 2011-009046
Application 11/838,103

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STATEMENT OF THE CASE
Claims 239-241, 243, 244, and 251-258 on appeal, and can be found
in the Claims Appendix of the Appeal Brief (App. Br. 12-14). Claim 239 is
the sole independent claim and is representative of the claims on appeal, and
reads as follows:
239. A system including a rigid introducer device that is useable to
facilitate insertion of an implant into the prostate gland of a human or
animal subject, comprising:
an implant delivery device housing the implant, wherein the
implant includes a proximal anchor connected to a distal anchor by a
tensioning element;
the introducer device including:
a rigid elongate body that is insertable into the subject's
urethra;
a rigid scope lumen configured to receive a cystoscope or
other endoscopic device; and
a rigid working lumen through which at least one implant
delivery device for placing a prostate compression implant is
advanced, and an outlet through which the implant delivery
device exits the introducer device and advance through the wall
of the urethra and to a position within or near the prostate
gland.
The Examiner has rejected the claims as follows:
I. Claims 239, 241, 243, 244, 251-256, and 258 under 35 U.S.C.
§ 103(a) as unpatentable over Bacich
2
in view of Mikus;
3

II. Claim 240 under 35 U.S.C. § 103(a) as unpatentable over
Bacich view of Williams;
4

III. Claim 257 under 35 U.S.C. § 103(a) as unpatentable over
Bacich and Mikus in further view of Othel-Jacobsen.
5

2
Steven R. Bacich et al., US 5,749,889, issued May 12, 1998.
3
Paul W. Mikus et al., US 6,702,846 B2, issued Mar. 9, 2004.
4
William B. Williams III et al., US 5,237,984, issued Aug. 24, 1993.
Appeal 2011-009046
Application 11/838,103

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The Issue: Obviousness over Bacich and Mikus
The Examiner takes the position that Bacich disclosed a device that
“has a scope lumen 130 configured to receive an endoscope 110 and a
working lumen 142 for advancing a working device. The working lumen
has an outlet through which the working device may exit the introducer
device and advance through the wall of the urethra and be positioned near
the prostate gland.” (Ans. 3.) The Examiner finds that the “guide channel is
made of cross-linked, noncompliant materials that have a substantially
inelastic nature . . . the membrane. . . [does] not [have] any longitudinal
expansion.” (Id. at 8.) The Examiner takes the position that the “the device
in both axes is deficient in flexibility in that it has some resistance to it and is
devoid of flexibility in the longitudinal direction.” (Id.) The Examiner
concludes “[a]s both lumens/channels are rigid/inelastic/non-compliant the
elongate body which encloses both lumens is rigid.” (Id. at 4.) The
Examiner concedes that Bacich “does not disclose an implant including a
proximal anchor connected to a distal anchor by a tensioning means.” (Id.)
The issue is: Does the combination of references disclose or suggest a
device having both a rigid scope lumen and a rigid working lumen?

Findings of Fact
FF 1. Bacich disclosed a medical device that can be inserted through
a bodily orifice such as the urethra (Bacich, col. 1, l. 19; Ans. 3). Figures 3
and 4, reproduced below, depict a cross section of the device:

5
Erik Othel-Jacobsen et al., US 5,098,374, issued Mar. 24, 1992.
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Application 11/838,103

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(Bacich, Fig. 3, 4.) Fig. 3 and 4 of Bacich show a cross-sectional view of an
access device with and without a secondary instrument inserted into the
channel 140.
FIG. 3 is a cross-sectional view of the access device . . .
illustrating the main channel and guide channel in their initial
state upon insertion of the access device into the body and prior
to deployment of a secondary instrument through the guide
channel.
FIG. 4 is a cross-sectional view of the access device . . .
illustrating the guide channel of the present invention in a
released or expanded state as the secondary instrument is
advanced therethrough.
(Bacich, col. 8, ll. 41-51.)
FF 2. Bacich disclosed that the “surgical access device being
provided which has a substantially rigid main channel and an expandable
guide channel. The guide channel initially has a pre-deployment or pre-
insertion position such that a cross-section of an inserted portion of the
device is substantially the same as a cross-section of the main channel.”
(Bacich, col. 8, ll. 3-9 (emphasis added); Ans. 4.)

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Application 11/838,103

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Principle of Law
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or
argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993).

Analysis
The same issue is dispositive for all three obviousness rejections, so
we will consider them together. All three rejections rely upon the teaching
of Bacich regarding the introducer device having a rigid main channel and a
rigid guide channel.
Appellants contend that the “the lumen 142 of Bacich et al. is in fact
made of a material enabling it to be folded to form a double layer. Such
material is not rigid as the term rigid is defined in the present application.”
(App. Br. 7.)
We are not persuaded by the Examiner’s assertion that the guide
channel of Bacich is indeed a rigid structure. The Examiner is relying on the
lack of stretch in the material of the guide channel to imply that the channel
is indeed rigid (Ans. 8). The Examiner reasons that “the guide channel is
made of cross-linked, noncompliant materials that have a substantially
inelastic nature.” (Id.)
Bacich, however, describes that the introducer has a “substantially
rigid main channel and an expandable guide channel.” (FF 2.) Thus,
Bacich recognizes that the expandable guide channel is something other than
rigid. The expandable feature of the guide channel is shown in the cross
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Application 11/838,103

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sectional view of the introducer of Bacich (FF 1). During the insertion
phase the guide channel takes on the shape and structure of the rigid main
channel and once inserted into the body another instrument can then be slid
into the guide channel expanding the channel as seen in Fig. 4 (FFs 1-2).
The change in the shape of the guide channel indicates that the material is
malleable/changeable in at least the outward direction by allowing an
instrument to slide through the inner passageway. We do not find that
Bacich meets the claim elements of having a rigid scope lumen and a rigid
working lumen. Therefore, we are compelled to reverse the Examiner’s
rejections based on Bacich. We find that the Examiner has advanced no
reasonable alternative rationale explaining why an ordinary artisan would
have arrived at a rigid working lumen based on the combination of
references. We are not persuaded that the Examiner has made a prima facie
case of obviousness with respect to claim 239. We, therefore, reverse the
Examiner’s obviousness rejections because Bacich fails to disclose both a
rigid scope lumen and a rigid working lumen.

SUMMARY
We reverse the rejection of claims 239, 241, 243, 244, 251-256, and
258 under 35 U.S.C. § 103(a) as unpatentable over Bacich in view of Mikus.
We reverse the rejection of claim 240 under 35 U.S.C. § 103(a) as
unpatentable over Bacich view of Williams.
We reverse the rejection of claim 257 under 35 U.S.C. § 103(a) as
unpatentable over Bacich and Mikus in further view of Othel-Jacobsen.

Appeal 2011-009046
Application 11/838,103

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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).

REVERSED

cdc