Ex Parte Copa et al

Patent Trial and Appeal Board

Sep 17, 2012

11804114 (P.T.A.B. Sep. 17, 2012)

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 2011-012013
Application 11/804,114
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 appeal
1
under 35 U.S.C. § 134(a) from the rejection of
claims directed to methods of performing urethral anastomosis. The Patent
Examiner rejected certain claims for anticipation, and the remaining claims
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 10/646,383 and
10/919,775 are related. (App. Br. 4.) The appeal in „383 (Appeal No. 2011-
012383) 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 15-51 are on appeal. Claim 15 is representative and reads as
follows:
15. A method of performing urethral anastomosis, the method comprising
inserting a portion of an anastomosis device into a urethra through a
meatus, the anastomosis device comprising
a distal end comprising a balloon and elongate tissue
approximating structure located on a proximal side of the balloon,
inflating the balloon in the bladder, and
using the tissue approximating structure to hold severed tissue
together during healing.

The Examiner rejected the claims as follows:
claims 15-17, 20, 26, 28-34, and 37-45 under 35 U.S.C. § 102(b) as
anticipated by Sharkey;
2

claims 18, 19, 21-25, and 27 under 35 U.S.C. § 103(a) as unpatentable
over Sharkey; and
claims 35, 36, and 46-51 under 35 U.S.C. § 103(a) as unpatentable
over Sharkey and Kirsch.
3

ANTICIPATION
The Issue
The Examiner‟s position is that Sharkey described a method of
performing anastomosis on the urethra and bladder which is the same as the
method Appellants claim. (Ans. 4-5.) Among other facts, the Examiner
found that Sharkey described using an anastomosis device comprising a
balloon, bladder sealer, or first tissue approximating structure 32, and a

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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second tissue approximating structure 36 or 10. (Ans. 4.) The Examiner
found that “[s]ince the tissue second approximating structure 36 or 10 urges
the bladder and the urethra together to allow anastomosis, it is considered to
begin the healing process, and therefore holds the severed tissue together
„during healing.‟” (Id.)
Appellants argue their method is different from Sharkey‟s because it
uses a different device. More specifically, Appellants contend the rejection
“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. 10.)
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.)
The issues with respect to this rejection are:
(a) does the claim term “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. The Specification discloses:
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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.)
2. 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].)
3. The Specification states: “Alternatively, the tissue approximating
structure may include one or two balloons that can be positioned to
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cause contact of two opposing severed tissue surfaces.” (Id. at ll. 22-
23 (¶ [0036].)
4. The Specification does not expressly disclaim elongate balloons.
5. Sharkey disclosed a “Passive Fixation Anastomosis Method And
Device.” (Sharkey, Title (emphasis omitted).)
6. 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.)
7. Sharkey‟s Figure 11 is reproduced here:

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

8. Sharkey‟s Figure 13 is reproduced here:

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“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.)

9. 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.)
10. The Examiner found that Sharkey‟s “tissue approximating structure
10 has multiple tines, such as 16 or the ends of 12, 14 (Figures 1 and
4-6).” (Ans. 4.)
11. Sharkey‟s Figure 4 is reproduced here:

“FIG. 4 shows a coiled passive fixation device in a deployed
position. The proximal end is expanded to a generally cylindrical
geometry, while the distal end is substantially conical.” (Sharkey, col.
4, ll. 3-6.)

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12. 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 col. 7, ll. 23-40.)
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.
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[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, 213 (CCPA 1971).

Analysis
Claims 15, 28, and 31
(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 1.) The Specification explains that a balloon may be a tissue
approximating structure. (Id.; see also FF 3.) 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 2.)
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). 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.
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(b) There is no dispute that Sharkey described a method of urethral
anastomosis comprising inserting a portion of an anastomosis device into a
urethra, inflating a balloon in the bladder, and using a tissue approximating
structure to hold severed tissue together during healing. Sharkey disclosed
balloon 36 in its anastomosis device. (FF 7, 8.) 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 Schreiber,
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 mentioned conical, spherical, and cylindrical
shapes (FF 8), 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 that Sharkey described a method having all the steps of
Appellants‟ method.
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 claim 1, 9, or 26,
according to dependence. 37 C.F.R. § 41.37(c)(1)(vii).

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Claims 20, 32, and 33
(a) Claim 20 recites: “The method of claim 15 wherein the tissue
approximating structure comprises multiple tines.”
The Examiner found that Sharkey‟s tissue approximating structure 10
had multiple tines, including 16 and the ends of coils 12 and 14. (FF 10.)
Appellants contend that the elongate tissue approximating structure is
located on the proximal side of the balloon. (App. Br. 14.) The balloon
referred to is the one positioned in the bladder. According to Appellants,
connecting section 16 is not a tine, and Sharkey‟s device did not have the
requisite multiple tines on the proximal side of the balloon. (Id. at 15.)
The Examiner responds:
the tissue approximating structure 10 of Sharkey et al. has multiple
tines (i.e. at least two tines), such as one end 16 of coil 12 which is a
slender projection from the coil, and the opposite end of coil 12 or the
free end of the last turn of the coil 12 (Figures 1 and 4-6) that are
proximal to balloon 32.

(Ans. 9.)
We agree that the ends of coils 12 and 14 are tines. However, 16 is
the connector between the two coils, and we agree with Appellants that the
rejection does not explain how the connector could reasonably be considered
to be a tine. It appears from Sharkey‟s Figures that there is only one coil end
(tine) on the proximal side of the balloon positioned in the bladder, not
multiple tines. We therefore agree with Appellants that the rejection of
claim 20 must be reversed.
(b) Claim 32 recites: “The method of claim 31 wherein the first tissue
approximating structure is selected from the group consisting of a balloon
and a balloon-like structure.”
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According to the Examiner, Sharkey‟s balloon 32 corresponds to the
claimed “first tissue approximating structure” because it
is extended (expanded) to contact bladder tissue and prevent urine
from contacting an anastomosis site (col. 7, lines 55-67). Since the
elongate flexible body or Foley catheter 18 may remain in the bladder
during healing for a time period of about two to eight weeks for
drainage (col. 7, line 64 to col. 8, line 5) and would be held in place
by first tissue approximating structure 32, after healing the tissue
approximating structure 32 may be retracted (deflated) into the
anastomosis device in order to remove it from the urethra.

(Ans. 5.)
Appellants contend that “the rejection of claims 32 and 33, reciting a
„tine, a probe, a prod [or] a needle,‟ are similarly not sustainable.” (App. Br.
15.) As claim 32 recites a balloon, not a tine, probe, prod or needle,
Appellants‟ argument is unpersuasive as to claim 32. The rejection of claim
32 is affirmed.
Claim 33 recites: “The method of claim 31 wherein the elongate
second tissue approximating structure comprises movable elongate structure
selected from a tine, a probe, a prod, and a needle.” Sharkey‟s coil 12 does
comprise a tine at its end, and the tine is movable because it moves as the
coil is expanded by Sharkey‟s balloon 36. Appellants‟ argument is therefore
unpersuasive as to claim 33. The rejection of claim 33 is affirmed.

OBVIOUSNESS
A. The rejection over Sharkey.
The Issue
The Examiner‟s position is that although Sharkey described a method
of anastomosis of a urethra with a bladder, Sharkey did not describe end-to-
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end urethral anastomosis. (Ans. 6; Final Rej. 4.) As Sharkey taught
anastomosis of body lumens not limited to the urethra and the bladder, the
Examiner concluded it would have been obvious
to modify the method and device of Sharkey et al. by applying the
tissue approximating structure to two opposing urethral portions, since
it Sharkey et al. recognizes the anastomosis between any two body
ducts, such as two opposing urethral portions below a perineal wall,
which may be effectively anastomized for incontinence applications
after a urethral stricture is severed or resected, which is well known in
the art.

(Ans. 6; Final Rej. at 4-5.)
Appellants state that the rejected claims depend from claim 15 and
require the device of claim 15. (App. Br. 17.) Appellants note that the
device claimed in claim 15 requires “‟a distal end comprising a balloon and
elongate tissue approximating structure located on a proximal side of the
balloon.‟” (Id., emphasis omitted.) Appellants argue:
The rejections of record rely on the premise that one of skill
would have had a reason to modify the Sharkey device as follows:
1) remove balloon 36 on the proximal side of balloon 32,
and
2) replace that balloon with two opposing elongate tissue
approximating structures.

(Id.) According to Appellants, “[t]his basis of rejection finds no support in
any prior art of record, especially not the Sharkey reference.” (Id.)
Discussion
Appellants‟ contentions are misdirected. The rejection did not
propose removing and replacing a balloon. As Appellants do not dispute the
Examiner‟s actual findings and conclusions, we affirm the rejection.

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B. The rejection over Sharkey and Kirsch
The Issue
The Examiner‟s position is that Sharkey disclosed the claimed method
“except for retracting the (second) tissue approximating structure 36, which
is on the proximal side of the first tissue approximating structure or balloon
32, into the anastomosis device after the healing period, wherein the tissue
approximating structure includes proximal and distal opposing tine
structures.” (Ans. 7.) The Examiner found that “Kirsch et al. teach a
selectively retractable tissue approximating tine structures 30 which may be
retracted into an anastomosis device 24 (Figures 1-11 B),” and concluded
“[i]t would have been obvious to modify the second tissue approximating
structure of Sharkey et al. balloon 36 with opposing retractable tines, as
taught by Kirsch et al., in order to provide a quicker and simpler way to
activate the tissue approximating structure (col. 1, lines 38-40).” (Id.) The
Examiner noted that Sharkey suggested substituting its balloons 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]‟ (col. 7, lines 15-22),” and concluded “it would have been obvious to
one of ordinary skill in the art to consider the teaching of distal and proximal
selectively retractable tines of Kirsch et al. for deploying the anastomosis
device in Sharkey et al., and since it was well known in the art to use
radially expandable structures as alternatives to radially inflatable
structures.” (Id. at 7-8.)
Appellants contend that Kirsch‟s tines “would not perform the
function of the Sharkey balloon.” (App. Br. 21.)
The Examiner responds:
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Kirsch et al. teach using elongate tissue approximating structures 30
that selectively expand and retract to secure a clip/anastomosis device
38 and facilitating the approximation of tissue portions by anchoring
the urethral stump and bladder neck to ensure proper connection
between the urethra and bladder (col. 1, lines 38-40), and therefore it
would have been obvious to one of ordinary skill in the art to modify
the balloons 32 and 36 of Sharkey et al. with the structures 30 of
Kirsch et al to selectively expand/retract the tissue approximating
members.

(Ans. 9-10.)
Further Findings of Fact
13. 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.)
14. Kirsch disclosed a “Method And Device For Urethral-Vesicle
Anastomosis.” (Kirsch, Title (emphasis omitted).)
15. Kirsch‟s Figure 11B is reproduced here:

FIG. 11B 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.)
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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, when replacing balloon 36 as shown in
Sharkey‟s Figure 13 (see FF 8 above), the distensible members would be
used to expand coil 12. Appellants dispute that Kirsch‟s tines could perform
this function. The Examiner finds that Kirsch‟s tines “secure a
clip/anastomosis device 38 and facilitating the approximation of tissue
portions by anchoring the urethral stump and bladder neck.” (Ans. 9-10.)
No evidence is cited to support finding that Kirsch‟s tines secure a clip. In
Kirsch‟s figures, the tines are not shown in contact with a clip. In Kirsch‟s
Figure 11B, for example, the tines engage tissue, not clips. (FF 15.) On this
record, 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.

SUMMARY
We affirm the rejection of claims 15-17, 26, 28-34, and 37-45 under
35 U.S.C. § 102(b) as anticipated by Sharkey.
We reverse the rejection of claim 20 under 35 U.S.C. § 102(b) as
anticipated by Sharkey.
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We affirm the rejection of claims 18, 19, 21-25, and 27 under
35 U.S.C. § 103(a) as unpatentable over Sharkey.
We reverse the rejection of claims 35, 36, and 46-51 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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