Ex Parte Copa et al

Patent Trial and Appeal Board

Feb 19, 2015

10919545 (P.T.A.B. Feb. 19, 2015)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte VINCENT G. COPA and KORY P. HAMEL
__________

Appeal 2012-007226
Application 10/919,545
Technology Center 3700
__________

Before DEMETRA J. MILLS, ULRIKE W. JENKS, and
ROBERT A. POLLOCK, Administrative Patent Judges.

MILLS, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part.
Appeal 2012-007226
Application 10/919,545

2
STATEMENT OF CASE
According to the Specification, anastomosis procedures are required
for connecting or re-connecting body tissue, e.g., as part of a surgical
procedure. Spec. 1. The tissue, for example,
[M]ay be part of a body lumen such as a blood vessel, intestinal
or other digestive system tissue, or tissue relating to the urinary
system. As one example, in a radical prostatectomy, a surgeon
removes all or most of a patient’s prostate. Because the urethra
travels through the prostate immediately before reaching the
bladder, the upper part of the urethra is also removed with the
surgery. The procedure leaves a severed urethral stump and a
severed bladder neck. To restore proper urinary functions, the
bladder and the urethra must be reconnected.

Id.
The following claims are representative.
1. An anastomosis device comprising:
an elongate body comprising a proximal end, a distal end, and an open
drainage lumen extending through at least a portion of a length of the
elongate body,
a drainage aperture at a distal end of the elongate body for
communication with the proximal end of the elongate body through the
drainage lumen, wherein the open drainage lumen comprises an unobstructed
passage from the proximal end of the elongate body to the drainage aperture,
a balloon spaced from the drainage aperture along the length of the
elongate body, and at least one elongate distal tissue approximating structure
at the distal end of the elongate body and outwardly extendable from the
elongate body on a proximal side of the balloon along the length of the
elongate body so that a distal end of each distal elongate tissue approximating
structure is spaced from the elongate body; and
at least one elongate proximal tissue approximating structure, each of
which is outwardly extendable from the elongate body on a proximal side of
the distal tissue approximating structure so that a distal end of each proximal
elongate tissue approximating structure is spaced from the elongate body.

Appeal 2012-007226
Application 10/919,545

3
13. An anastomosis device comprising
an elongate body having a body wall, a proximal end, and a distal end,
a drainage aperture at the distal end,
a drainage lumen extending along at least a portion of a length of the
elongate body and connecting the drainage aperture to the proximal end,
an inflatable balloon spaced proximally from the drainage aperture
along the length of the elongate body,
an inflation lumen extending within a length of the body wall,
connecting the balloon to the proximal end,
distal tissue approximating structure comprising at least one distal tine
connected to a distal frame, each distal tine extendably supported within an
aperture of a distal tine deflector,
a distal actuating mechanism operably connecting the distal frame to
the proximal end of the device, through an actuating lumen extending along a
length of the elongate body in the body wall,
proximal tissue approximating structure comprising at least one
proximal tine connected to a proximal frame, each proximal tine extendably
supported within an aperture of a proximal tine deflector,
a proximal actuating mechanism operably connecting the proximal
frame to the proximal end of the device, through the actuating lumen.

20. An anastomosis device comprising
an elongate body having a body wall, a proximal end, and a distal end,
and an open drainage lumen extending through at least a portion of a length
of the elongate body, the open drainage lumen comprising an unobstructed
passage from the proximal end of the elongate body to the drainage aperture,
a drainage aperture at the distal end,
an inflatable balloon located on a proximal side of the drainage
aperture along the length of the elongate body,
an inflation lumen extending within a length of the body wall,
connecting the balloon to the proximal end,
distal tissue approximating structure at the distal end of the elongate
body and comprising at least one distal tine connected to a distal frame, each
distal tine extending through an aperture located within the body wall at a
location along a length of the body wall on a proximal side of the drainage
aperture, and each distal tissue approximating structure being capable of
extending from and retracting into the body wall through the aperture,
Appeal 2012-007226
Application 10/919,545

4
a distal actuating mechanism operably connecting the distal frame to
the proximal end of the device through an actuating lumen extending along a
length of the elongate body in the body wall,
proximal tissue approximating structure at the distal end of the
elongate body and comprising at least one proximal tine connected to a
proximal frame, each proximal tine extending through an aperture located
within the body wall at a location along a length of the body wall on a
proximal side of the drainage aperture, and each proximal tissue
approximating structure being capable of extending from and retracting into
the body wall through the aperture,
a proximal actuating mechanism operably connecting the proximal
frame to the proximal end of the device, through the actuating lumen.

Cited References

Sharkey et al. US 5,540,701 July 30, 1996
(hereinafter “Sharkey”)
Kirsch et al. US 6,461,367 B1 Oct. 8, 2002
(hereinafter “Kirsch”)

Grounds of Rejection
Claims 1, 4–13, and 19–26 are rejected under 35 U.S.C. § 103(a) as
being unpatentable over Sharkey in view of Kirsch.

FINDINGS OF FACT
The Examiner’s findings of fact are set forth in the Answer at pages
5–7. The following facts are highlighted.
1. The Specification defines the term, “tissue approximating
structure” as
The terms “tissue approximating” and simply
“approximating” refer to a process of bringing or holding
body tissues in contact for healing. Examples include: the
process of bringing severed surfaces of a bladder neck
Appeal 2012-007226
Application 10/919,545

5
and a urethral stump, or two opposing severed urethral
tissues, into contact for healing; and the process of
holding severed surfaces of a bladder neck and a urethral
stump, or two opposing severed urethral tissues, together
for healing.

Spec. 5.
2. Claim 1 uses the term “elongate proximal tissue approximating
structure.” The structure of claim 1 is not limited to tines.
3. The term “elongate” means “[h]aving more length
than width; slender.” http://www.thefreedictionary.com/elongate

ISSUE
The issue is: Does the cited prior art support the Examiner’s finding
that the claimed subject matter is obvious?

PRINCIPLES OF LAW
In making our determination, we apply the preponderance of the
evidence standard. See, e.g., Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427
(Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings
before the Office). The Board “determines the scope of claims in patent
applications not solely on the basis of the claim language, but upon giving
claims their broadest reasonable construction ‘in light of the specification as
it would be interpreted by one of ordinary skill in the art.’” Phillips v. AWH
Corp., 415 F.3d 1303, 1316 (Fed. Cir. 2005) (quoting In re Am. Acad. of Sci.
Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004).
Appeal 2012-007226
Application 10/919,545

6
“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) (citations omitted). In order to determine whether a prima facie
case of obviousness has been established, we consider the factors set forth in
Graham v. John Deere Co., 383 U.S. 1, 17 (1966): (1) the scope and content
of the prior art; (2) the differences between the prior art and the claims at
issue; (3) the level of ordinary skill in the relevant art; and (4) objective
evidence of nonobviousness, if present.
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
“[O]bviousness requires a suggestion of all limitations in a claim.”
CFMT, Inc. v. Yieldup Int’l Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003)
(citing In re Royka, 490 F.2d 981, 985 (CCPA 1974)).

ANALYSIS
Claim 1
We find that the Examiner has provided evidence to support a prima
facie case of obviousness for the subject matter of claim 1.
The Examiner finds that Sharkey teaches an anastomosis device
comprising each element claimed “except for another elongate tissue
approximating structure that is on the proximal side of the (distal) tissue
approximating structure, and both the distal end of the proximal and distal
Appeal 2012-007226
Application 10/919,545

7
elongate tissue approximating structures being spaced from the elongate
body . . . .” Ans. 6.
Appellants contend that the “Sharkey et al. reference does not disclose
any type of tissue approximating structure that is elongate and which has a
distal end that is spaced from the elongate body.” Br. 12.
We are not persuaded. The term “elongate” means “[h]aving more
length than width.” FF3. Sharkey discloses several configurations of a
passive fixation anastomosis device, which are reproduced below.

Figures 1–4 of Sharkey show various embodiments of an anastomosis
device having a proximal and distal end, and which are longer than they are
wide, i.e., elongate. See also Sharkey abstract indicating the device is
“defined by a generally elongated body.” While the Examiner cites to
Kirsch to provide tine structures, such tine structures are not recited in
Appeal 2012-007226
Application 10/919,545

8
claim 1. Appellants point to no other structure missing from claim 1, and
therefore, the obviousness rejection of claim 1 is affirmed.
Appellants provide no separate arguments for claims 4–7, 19, and 24–
26 and therefore we also affirm the rejections of these claims. Arguments
not made are waived. See 37 C.F.R. § 41.37(c)(1)(vii).

Claims 8–13, and 20–23
The Examiner relies on Kirsch for teaching
[A]n elongate body 24 having tissue approximating structures
comprising elongate extendable/retractable tine frames (pairs of
tines for both the proximal and distal tine structures 30)
including distal approximating structures (“everting prongs”)
30 (engaging tissue of the bladder 12, for instance) and
proximal approximating structures 30 (engaging tissue of the
urethra 10, for instance) which are slidably supported by the
elongate body and actuated by a distal actuating mechanism 76
and a proximal actuating mechanism (“everting wires”) 76,
respectively.

Ans. 6. The Examiner concludes that
It would have been obvious to one of ordinary skill in the
art at the time of invention to modify the proximal tissue
approximating structure or proximal balloon 36 with proximal
and distal approximating tines, as taught by Kirsch et al., in
order to facilitate the approximation of the tissue portions by
anchoring the urethral stump and bladder neck with a process
that is more efficient and simple to use (col. 1, lines 38-40), as
well as to lower the profile of the device when in a retracted
state during delivery to the anastomosis site.
Further Sharkey et al. also acknowledge that instead of
the inflatable balloon tissue approximating structures 32 and 36
that “distensible members that are mechanically extended and
retracted in order to deploy the proximal and distal ends 12 and
Appeal 2012-007226
Application 10/919,545

9
14 of [the anastomosis device]” may be used (col. 7, lines 15-
22), and therefore it would have been obvious to one of
ordinary skill in the art to consider the teaching of distal and
proximal selectively retractable tine frames of Kirsch et al. for
deploying the anastomosis device in Sharkey et al.

Ans. 7.

Appellants contend that
[T]he combination of references is faulty in that the Kirsch et al
reference fails to disclose any mechanical or other device or
structure that for expanding any type of device into place within
tissue. The prongs 30 of the Kirsch et al device are not similar
to or functionally equivalent to the balloons 32 and 36 of the
Sharkey et al. reference, which are used to provide outward
cylindrical force to expand a coil structure. These prongs 30 of
the Kirsch et al. reference instead are used to evert the open
ends of urethra and bladder tissue so that a clip can used [sic] to
hold the urethra to the bladder.

Br. 13.

We find that the Appellants have the better argument. The remaining
independent claims and dependent claims require that the tissue
approximating structure (for holding tissues in contact for healing)
comprises tines, in one form or another. Figures 5a and 5b of the
Specification are reproduced below.

Appeal 2012-007226
Application 10/919,545

10

Figures 5 and 5b show proximal and distal tines of an anastomosis
device for holding tissues in contact for healing. In contrast, the everting
prongs 30 of Kirsch function to provide a suitable gap between the bladder
everting unit and the urethra everting unit to apply clips to clamp together
the bladder and urethra. Figure 11a of Kirsch is reproduced below.

Figure 11a of Kirsch shows everting prongs 30. The everting prongs of
Kirsch do not hold the tissue in contact for healing, and thus are not a tissue
approximating structure, as claimed. Rather, it is the clips of Kirsch that
Appeal 2012-007226
Application 10/919,545

11
hold the tissue in contact for healing. For this reason, the rejection of claims
8–13, and 20–23 for obviousness is reversed.

CONCLUSION OF LAW
The cited references support the Examiner’s obviousness rejection of
claims 1, 4–7, 19, and 24–26 which are affirmed. The obviousness rejection
of claims 8–13, and 20–23 is reversed.

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).

AFFIRMED-IN-PART

cdc