Ex Parte Copa et al

Patent Trial and Appeal Board

Sep 17, 2012

10646383 (P.T.A.B. Sep. 17, 2012)

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.
10/646,383 08/21/2003 Vincent G. Copa AMS0008/US 9726
33072 7590 09/17/2012
KAGAN BINDER, PLLC
SUITE 200, MAPLE ISLAND BUILDING
221 MAIN STREET NORTH
STILLWATER, MN 55082
EXAMINER
YABUT, DIANE D
ART UNIT PAPER NUMBER
3734
MAIL DATE DELIVERY MODE
09/17/2012 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 VINCENT G. COPA, KORY P. HAMEL,
and SIDNEY F. HAUSCHILD
__________

Appeal 2011-012383
Application 10/646,383
Technology Center 3700
__________

Before DEMETRA J. MILLS, FRANCISCO C. PRATS, and
STEPHEN WALSH, Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134(a) from the rejection of
claims directed to an anastomosis device. The Patent Examiner rejected
certain claims for anticipation and the remainder for obviousness. We have
jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part.

1 Appellants state that appeals in co-pending applications 11/804,114 and
10/919,775 are related. (App. Br. 4.) The appeal in ‘114 (Appeal No. 2011-
012013) is being decided concurrently with this appeal. The appeal in ‘775
(Appeal No. 2010-006317) was decided on Sept. 7, 2012.
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STATEMENT OF THE CASE
Claims 1-9, 11-14, and 26-44 are on appeal. Claim 1 is representative
and reads as follows:
1. An anastomosis device comprising
a hollow, elongate, flexible catheter body having a proximal
end and a distal end, the distal end comprising a catheter body wall,
an inflatable balloon at the distal end,
a drainage aperture at the distal end, and
elongate tissue approximating structure that can be extended
and retracted from the catheter body wall at the distal end of the catheter
body on a proximal side of the inflatable balloon,
wherein the inflatable balloon is on a proximal side of the drainage aperture.

The Examiner rejected the claims as follows:
 claims 1, 2, 9, 11, 12, 14, 26-29, 35, 39, and 43 under 35 U.S.C.
§ 102(b) as anticipated by Sharkey;2 and
 claims 3-8, 13, 30-34, 36-38, 40-42, and 44 under 35 U.S.C. § 103(a)
as unpatentable over Sharkey and Kirsch.3

ANTICIPATION
The Issue
The Examiner found that Sharkey’s anastomosis device had all the
features of the device Appellants claim, arranged as Appellants claim them.
(Ans. 4.) Among the other features, the Examiner identified Sharkey’s
inflatable balloon 36 as a tissue approximating structure “that can be
extended (inflated) and retracted (deflated), from the catheter wall along the

2 Hugh R. Sharkey et al., US 5,540,701, July 30, 1996.
3 Wolff M. Kirsch et al., US 6,461,367 B1, Oct. 8, 2002.
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distal end of the catheter body on a proximal side of the inflatable balloon
[32] for holding severed tissue in contact for healing.” (Id.)
Appellants contend the rejection should be reversed because it “is
premised on the flawed argument that the balloon of the Sharkey reference is
‘elongate,’ and therefore is an ‘elongate tissue approximating structure’ as
recited in certain of Applicant's claims.” (App. Br. 11.) According to
Appellants, “even if the broadest reasonable meaning of the term ‘elongate’
could include the shape of the Sharkey balloon or cylinder, the claim feature
of an ‘elongate tissue approximating structure’ specifically excludes a
balloon, based on the content of Applicant's patent specification.” (Id.)
“The pending patent claims and specification use the terms ‘balloon’ and
‘elongate tissue approximating structure’ separately, to refer to different
types of structures, which means that the claim term ‘elongate tissue
approximating structure’ excludes the separately discussed structure of a
‘balloon,’ and vice-versa.” (Id., emphasis omitted.)
The Examiner responds:
the tissue approximating structures or balloons may be considered as
elongate structures since the geometry of the balloons may “impart
various geometrical configurations that are then used to expand
proximal and distal ends 12 and 14” which may be conical (col. 7,
lines 23-41), or “a generally cylindrical shape” (col. 5, lines 50-59)
and therefore may be considered elongate structures. Furthermore, the
balloons 32, 36 of Sharkey et al. read on an “elongate tissue
approximating structure” since they exhibit a length when deflated or
inflated, or are drawn out to a greater length when inflated.

(Ans. 7.)
Appellants reply that Sharkey’s balloon “lacks any elongate structure
(long and narrow) that can be extended from the catheter wall, as claimed,”
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and reiterate their point that their Specification’s “description of the claimed
elongate structure excludes a balloon.” (Reply Br. 6.)
The issues with respect to this rejection are:
(a) does “elongate tissue approximating structure” reasonably
include a balloon; and, if so,
(b) did Sharkey describe a balloon with an elongate structure?
Findings of Fact
1. We adopt the Examiner’s findings.
2. The Specification discloses:
A tissue approximating structure according to the invention can
be a structure of the device that can be used to cause contact between
severed tissues, such as severed urethral tissues, or such as severed
tissue of the bladder or bladder neck with severed tissue of the
urethral stump or perineal floor, or alternatively or additionally to
hold severed tissue surfaces in contact with each other for healing.
The tissue approximating structure may include, for example, one or
multiple balloon or balloon-like structures that can be placed against
the inside of the bladder or underneath the perineal floor to bring the
severed bladder neck tissue into contact with the severed tissue
surface of the urethral stump. Alternately, the tissue approximating
structure may include elongate structures such as a needle, tine, prod,
probe, or the like, which may have a blunt or a sharp end and may
movably extend or protrude from an aperture in a flexible catheter
body at a location where the structure can function as an
approximating structure, e.g., at the distal end of the device where the
structure will be near the bladder or perineal wall (when installed), or
at a severed urethra below the perineal floor (when installed).
Combinations of balloons and elongate structures may also be useful
in certain applications. The tissue approximating structure does not
require and can preferably exclude sutures and any component or
structure designed to function in combination with a suture or suturing
device such as a needle.

(Spec. 7, ll. 10-27 (¶ [0030]), emphasis added.)
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3. The Specification discloses examples of tissue approximating
structure:
Exemplary tissue approximating structure may be in the form of
a rigid elongate structure that moves from a retracted position (e.g.,
inside of the catheter body) to an extended position through apertures
in the catheter body, such as a movable, elongate, tine or needle type
structure.

(Id. at 9, ll. 13-21 (¶ [0035].)
4. The Specification states: “Alternatively, the tissue approximating
structure may include one or two balloons that can be positioned to
cause contact of two opposing severed tissue surfaces.” (Id. at 9, ll.
22-23 (¶ [0036].)
5. The Specification does not expressly disclaim elongate balloons.
6. Sharkey disclosed a “Passive Fixation Anastomosis Method And
Device.” (Sharkey, Title.)
7. Sharkey taught that its device could be inserted into a body lumen,
was particularly useful for urology applications, and that it could be
used for anastomosis of a urethra with a bladder following a
prostatectomy. (Id. at col. 6, ll. 50-58.)
8. Sharkey’s Figure 11 is reproduced here:

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“FIG. 11 is a cross-sectional view of a Foley type catheter with two
expanded balloons. The first balloon has a generally spherical shape,
while the second one is conical.” (Sharkey, col. 4, ll. 27-29.)

9. Sharkey’s Figure 13 is reproduced here:

“FIG. 13 illustrates the placement of the passive fixation device
around the Foley catheter of FIG. 11. Both balloons have been
expanded to deploy the passive fixation device. The proximal end has
been expanded with a spherical balloon, and the deployed proximal
end has a cylindrical geometry. The distal end has been expanded with
a conical shape balloon which imparts a conical geometry to the distal
end of the passive fixation device.” (Id. at ll. 33-40.)

10. Sharkey taught: “In FIG. 13, passive fixation device 10 is positioned
so that balloons 32 and 36 are inflated, causing proximal end 12 and
distal end 14 to be expanded to their deployed positions.” (Id. at col.
7, ll. 12-15.)
11. Sharkey taught that “[t]he geometry of balloons 32 and 36 can be such
that when inflated they impart various geometrical configurations that
are then used to expand proximal and distal ends 12 and 14,”
mentioning conical, spherical, cylindrical, and “[o]ther geometries of
balloons 32 and 36 are possible, depending on the desired deployed
shape of distal end 14 and proximal end 12.” (Id. at ll. 23-40.)

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Principles of Law
[T]he PTO applies to the verbiage of the proposed claims the
broadest reasonable meaning of the words in their ordinary
usage as they would be understood by one of ordinary skill in
the art, taking into account whatever enlightenment by way of
definitions or otherwise that may be afforded by the written
description contained in the applicant’s specification.

In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997). “When the applicant
states the meaning that the claim terms are intended to have, the claims are
examined with that meaning.” In re Zletz, 893 F.2d 319, 321 (Fed. Cir.
1989) (citations omitted). “Absent claim language carrying a narrow
meaning, the PTO should only limit the claim based on the specification or
prosecution history when those sources expressly disclaim the broader
definition.” In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004).
To anticipate a claim, a prior art reference must disclose every
limitation of the claimed invention, either explicitly or
inherently. Anticipation is an issue of fact, and the question
whether a claim limitation is inherent in a prior art reference is
a factual issue.

In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997) (citations omitted).
“It is well settled that the recitation of a new intended use for an old product
does not make a claim to that old product patentable.” Id.
[W]here the Patent Office has reason to believe that a functional
limitation asserted to be critical for establishing novelty in the claimed
subject matter may, in fact, be an inherent characteristic of the prior
art, it possesses the authority to require the applicant to prove that the
subject matter shown to be in the prior art does not possess the
characteristic relied on.

Id. at 1478, quoting In re Swinehart, 439 F.2d 210, 212 (CCPA 1971).

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Analysis
Claims 1, 9, and 26
(a) The Specification first explains the function of a tissue approximating
structure as one that “can be used to cause contact between severed tissues.”
(FF 2.) The Specification explains that a balloon may be a tissue
approximating structure. (Id.; see also FF 4.) The Specification explains
that the tissue approximating structure “[a]lternately . . . may include
elongate structures such as a needle, tine, prod, probe.” (Id.; see also FF 3.)
Statements in the Specification that a tissue approximating structure
“may” be a balloon or “may” be “elongate structures such as a needle” are
permissive, not mandatory instructions that only one or the other must be
chosen. E.g., In re Johnston, 435 F.3d 1381, 1384 (Fed. Cir. 2006)
(agreeing with Board that “may” was permissive in claim). Appellants rely
on the word “alternately” to convey the mandatory instruction that if an
elongate structure is to be used, it must be a needle or tine, not a balloon.
(App. Br. 12; Reply Br. 6-7.) We find the argument unpersuasive. Nothing
in the Specification prohibits an elongate balloon from being used as the
tissue approximating structure. As to issue (a), we find the Examiner’s
interpretation of the claim is reasonable in light of the Specification.
(b) Sharkey disclosed balloon 36 in its anastomosis device. (FF 8, 9.)
The Examiner found, and Appellants do not dispute, that balloon 36 is a
tissue approximating structure, and we note Appellants’ teaching that a
balloon may so function. Accordingly, the evidence supports the
Examiner’s finding. See Schrieber, 128 F.3d at 1478. The Examiner also
found that Sharkey taught various shapes for the balloon, to be used to
impart particular shapes to the coil 12. Because Sharkey expressly
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mentioned conical, spherical, and cylindrical shapes (FF 11), we agree with
the Examiner’s finding that Sharkey described an elongate balloon. At least
the cylindrical embodiment would be elongate. To anticipate, “the reference
need not satisfy an ipsissimis verbis test.” In re Gleave, 560 F.3d 1331,
1334 (Fed. Cir. 2009). As to issue (b), the evidence supports the finding of
anticipation.
Conclusions
“Elongate tissue approximating structure” is reasonably interpreted in
light of the Specification to include a balloon, and Sharkey described an
elongate balloon. Claims 2, 11, 12, 14, 27-29, 35, 39, and 43 have not been
argued separately and therefore stand or fall with claims 1, 9, or 26,
according to dependence. 37 C.F.R. § 41.37(c)(1)(vii).

OBVIOUSNESS
The Issue
The Examiner’s position is that Sharkey described the claimed device
“except for the tissue approximating structure or the second tissue
approximating structure comprising multiple distal tines and multiple
proximal tines that all extend and retract from the catheter body wall at fixed
locations along the distal end of the catheter body, the fixed locations being
fixed with respect to the distal and proximal ends of the catheter body.”
(Ans. 5.)
The Examiner found that Kirsch described an anastomosis device
comprising multiple tissue approximating tines:
For instance, when the distal end 24 of the catheter body and the
proximal end 16 of the catheter body are fixed or connected together,
the distal tines may be extended and retracted by actuating knob 28 at
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a fixed location through apertures 46, and similarly the proximal tines
may be extended and retracted by actuating knob 18 through apertures
at a fixed location to secure a clip/anastomosis device 38 (Figures 1
and 5; see col. 3, line 32 to col. 4, line 14). Opposing tines 30 may
also be used as shown in Figures 11 A-B.

(Id. at 6.) The Examiner also found that Sharkey suggested replacing
inflatable balloons 32 and 36 with “distensible members that are
mechanically extended and retracted in order to deploy the proximal and
distal ends 12 and 14 of [the anastomosis device].” (Id., quoting Sharkey,
col. 7, lines 15-22.) The Examiner concluded that it would have been
obvious
to replace the (second) tissue approximating structure of Sharkey et al.
with one that comprises multiple distal and proximal opposing tines at
the distal end of a catheter body, as taught by Kirsch et al. in order to
facilitate the approximation of tissue portions by anchoring the
urethral stump and bladder neck with tines to ensure proper
connection between the urethra and bladder (col. 1, lines 38-40,
Kirsch et al.), as well as to selectively approximate tissue when
desired.

(Id.)
Appellants contend that “one of skill would not have removed the
balloon 36 from the Sharkey device and replaced the balloon with ‘prongs’
from the Kirsch reference.” (App. Br. 16.) According to Appellants,
“[n]either the Sharkey nor the Kirsch reference recognizes any utility for a
device that would result from the rejection's proposed structural
modification to produce a catheter body comprising two structures, one a
distal balloon and the second being an ‘elongate tissue approximating
structure’ in the form of a ‘a tine, a probe, a prod, [or] a needle.’” (Id.)
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Appellants dispute that Kirsch’s tines could perform the function of the
Sharkey balloon. (Id. at 18.)
The Examiner responds that the rejection did not rely on Kirsch to
teach the elongate tissue approximating structure “that anchors or secures
tissue, but rather relies on the Kirsch et al. teaching of selectively
expandable/retractable elongate tissue approximating structure tines 30 that
are capable of contacting tissue or holding severed tissue in contact for
healing, as required by the claims.” (Ans. 9.)
The issue with respect to this rejection is whether Kirsch’s tines could
perform the function of Sharkey’s balloon.
Further Findings of Fact
12. Sharkey taught:
Catheter 18 can also include one or more distensible members
that are mechanically extended and retracted in order to deploy
proximal and distal ends 12 and 14 of passive fixation device. An
actuator causes the distensible members to become mechanical
distended. After proximal and distal ends are deployed, the distended
ends are retracted. The distensible members can be used in place of
balloons 32 and 36.

(Sharkey, col. 7, ll. 15-22.)
13. Kirsch disclosed a “Method And Device For Urethral-Vesicle
Anastomosis.” (Kirsch, Title.)
14. Kirsch’s Figure 11A is reproduced here:
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FIG. 11A is a cross-sectional view of the joining of a bladder 12 and
urethra 10, employing a trocar 16 and sheath 24, each having tines 30.
(Kirsch, col. 3, ll. 5-7.)

Principles of Law
When determining whether a claim is obvious, an Examiner must
make “a searching comparison of the claimed invention – including all its
limitations – with the teachings of the prior art.” In re Ochiai, 71 F.3d 1565,
1572 (Fed. Cir. 1995).
Analysis
Sharkey taught that distensible members could be used in place of
balloon 36. (FF 12.) Thus, replacing the balloon 36 shown in Sharkey’s
Figure 13 (see FF 9 above), the distensible members would be used to
expand coil 12. Appellants dispute that Kirsch’s tines could perform this
function. (App. Br. 18.) The rejection cites Kirsch’s tines as being tissue
approximating tines, and in the “Response to Argument,” the Examiner
stresses that contacting tissue or holding tissue is the important feature. On
these facts, we find Appellants’ argument persuasive. The record does not
provide evidence that Kirsch’s tines could function as the “distensible
members” Sharkey called for as balloon replacement. Put another way, the
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critical point is not whether Kirsch’s tines were made to contact tissue but
that they were not made to work like the distensible members Sharkey
suggested, i.e., to contact and expand a coil like Sharkey’s coil 12.
Conclusion
The obviousness rejection is reversed because there is insufficient
evidence that Kirsch’s tines could perform the function Sharkey called for.

SUMMARY
We affirm the rejection of claims 1, 2, 9, 11, 12, 14, 26-29, 35, 39,
and 43 under 35 U.S.C. § 102(b) as anticipated by Sharkey.
We reverse the rejection of claims 3-8, 13, 30-34, 36-38, 40-42, and
44 under 35 U.S.C. § 103(a) as unpatentable over Sharkey and Kirsch.
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-IN-PART

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