Ex Parte Gellman et al

Patent Trial and Appeal Board

Jun 10, 2013

10093450 (P.T.A.B. Jun. 10, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte BARRY N. GELLMAN, JIANMIN LI,
and JOZEF SLANDA
__________

Appeal 2012-000538
Application 10/093,450
Technology Center 3700
__________

Before TONI R. SCHEINER, JEFFREY N. FREDMAN, and
ANNETTE R. REIMERS, Administrative Patent Judges.

SCHEINER, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 from the final rejection of
claims 1-15, 18, 19, 21, 24, 25, 27, 28, 30, and 32-40, directed to a system
and method for implanting an implant at an anatomical site. The Examiner
has rejected the claims as lacking written descriptive support. We have
jurisdiction under 35 U.S.C. § 6(b).

1 Appellants identify the Real Party-In-Interest as Boston Scientific Scimed,
Inc. (App. Br. 1).
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Application 10/093,450

2
STATEMENT OF THE CASE
Claims 1-15, 18, 19, 21, 24, 25, 27, 28, 30, and 32-40 are pending and
on appeal. Claims 16, 17, 20, 22, 23, 26, 29, and 31 have been canceled
(App. Br. 3). Claim 1 is representative:
1. A system for implanting an implant at an anatomical site in the
body of a patient, comprising:
a supportive sling;
a flexible envelope comprising an external surface and at least two
sleeves that are fixedly joined together, said envelope enclosing, at least
partially, said supportive sling and including a gap on said external surface
that exposes a width of the sling while said at least two sleeves are fixed
joined together; and
a spacer for placement adjacent to said urethra and between said
urethra and a portion of said supportive sling located under said urethra,
wherein said spacer is disposed near a middle portion of said envelope.
Claims 1-15, 18, 19, 21, 24, 25, 27, 28, 30, and 32-40 stand rejected
under 35 U.S.C. § 112, first paragraph, as lacking written descriptive support
(new matter).
We reverse.
WRITTEN DESCRIPTION
Independent claim 1 requires, in relevant part, a supportive sling, “a
flexible envelope comprising . . . at least two sleeves that are fixedly joined
together, said envelope enclosing, at least partially, said supportive sling and
including a gap . . . that exposes a width of the sling while said at least two
sleeves are fixed[ly] joined together” and a “spacer . . . disposed near a
middle portion of said envelope.” Independent claim 36 has essentially the
same limitation, while independent method claim 18 requires placing “a
spacer between the urethra of the patient and a mid portion of the sling
assembly.”
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According to the Examiner,
The spacer is disclosed as being located near the middle of the
envelope for placement against the urethra. This spacer fully
encloses the envelope, as shown in Fig. 5B. However, the
envelope shown in Fig. 5A or 5B is a different embodiment
than the envelope shown in Fig. 8I, which defines a gap.
Furthermore, the envelope of Fig. 8I has a hinge that would
prevent the spacer from fully enclosing the envelope. Since the
applicant has not disclosed that the spacer shown in Fig. 5A or
5B is capable for use with the envelope embodiment shown in
Fig. 8I, the claimed combination of said spacer and said
envelope raises the issue of new matter.
(Ans. 5.)
“In order to satisfy the written description requirement, the disclosure
as originally filed does not have to provide in haec verba support for the
claimed subject matter at issue.” Purdue Pharma L.P. v. Faulding, Inc.,
230 F.3d 1320, 1323 (Fed. Cir. 2000). Rather, the disclosure must convey
with reasonable clarity to those skilled in the art that the inventor was in
possession of the invention. See id.
The Specification discloses “devices, delivery systems and methods
for implanting an implant, such as a sling, at an anatomical site in the body
of a patient, such as at the mid-urethra” (Spec. ¶ 6), “while simultaneously
introducing a therapeutic agent or drug . . . to the patient's tissues during
delivery of the implant to the anatomical site” (id.). “Moreover, the system
. . . allows the operator to adjust and position the implant at the anatomical
site in the patient's body and to maintain the correct position of the implant
at the anatomical site during and after removal of the delivery system” (id.).
In other words, the Specification discloses a system and method that aids in
positioning the implant at the site and delivers a drug to the implant site.
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The components of the delivery system include “an envelope having
an inner surface and an outer surface” (id. at ¶ 7), wherein the envelope is
“configured to enclose an implant, and a spacer [is] disposed on at least one
of said inner surface or outer surfaces of the envelope that is useful for
positioning the implant at an anatomical site” (id. at ¶ 13).
The drug delivery feature of the delivery system may take many
forms, including “one or more apertures 50 . . . introduced into the envelope
20. The apertures 50 may be for example, cuts or slits . . . [which] extend
through the envelope 20 and . . . allow drug access to the inner surface 30 of
envelope 20” (id. at ¶¶ 134, 144). As shown in Figures 3A and 3B of the
present Specification, these apertures may be located virtually anywhere
along the length of the envelope. We note that the ordinary definition of an
aperture is “an opening, as a hole, slit, crack, gap, etc.”2
Inasmuch as the Specification is directed to an implant delivery
system that provides ease of implant positioning as well as drug delivery to
the implant site, we agree with Appellants that the Specification reasonably
conveys that Appellants were in possession of an implant system comprising
an envelope with an aperture (i.e., a gap) in its external surface that exposes
a width of the implant (i.e., the sling), in combination with a positioning
spacer disposed near the middle of the envelope (Reply Br. 4).

2 See e.g., http://dictionary.reference.com/browse/aperture
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SUMMARY
The rejection of claims 1-15, 18, 19, 21, 24, 25, 27, 28, 30, and 32-40
35 U.S.C. § 112, first paragraph, as lacking written descriptive support is
reversed.

REVERSED

cdc