Ex Parte Park et al

Patent Trial and Appeal Board

Feb 27, 2013

10175159 (P.T.A.B. Feb. 27, 2013)

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.
10/175,159 06/20/2002 Adrian Edward Park 14088.0002 5579
7590 02/28/2013
STEPTOE & JOHNSON LLP
1330 Connecticut Avenue, N.W.
Washington, DC 20036
EXAMINER
MASHACK, MARK F
ART UNIT PAPER NUMBER
3773
MAIL DATE DELIVERY MODE
02/28/2013 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 ADRIAN EDWARD PARK, CHARLES FRANCIS KNAPP,
WILLIAM EDWARD CHARASH, and HUA CUI
____________

Appeal 2011-009583
Application 10/175,159
Technology Center 3700
____________

Before JEFFREY N. FREDMAN, ERICA A. FRANKLIN, and
ULRIKE W. JENKS, Administrative Patent Judges.

JENKS, Administrative Patent Judge

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to an
anastomotic device for joining of lumens or hollow viscera. The Patent
Examiner has rejected the claims for obviousness. We have jurisdiction
under 35 U.S.C. § 6(b). We affirm.

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STATEMENT OF THE CASE
The Specification is directed to a device for creating a connection in
the gastrointestinal and enteric (including biliary) system to form a channel,
an anastomosis. “The woven tube of wire of the invention is a three
dimensional structure wherein the outer loops or ends of the woven tube fold
or loop back in a manner which holds the luminal interface of the
anastomotic site into apposition at the deployment site.” (Spec. 1.)
Claims 1, 2, 13, 14, 18, 19, and 24 are on appeal, and can be found in
the Claims Appendix of the Appeal Brief (App. Br. 13-15). Claims 1, 13,
and 18 are independent claims. Claim 1 is representative of the claims on
appeal, and reads as follows (emphasis added):
1. An anastomotic device for joining of lumens or hollow viscera
which is adapted to be deployed at a luminal interface of two adjacent
lumens, comprising a woven tube of wire having an elongated shape,
the elongated shape having a first center diameter between two
longitudinally spaced ends separated by a tube length, and a deployed
shape, the deployed shape having a second center diameter, wherein
the first center diameter is relatively smaller than the second center
diameter, and wherein the second center diameter forms an opening
between the lumens, the tube of wire constructed from a thermal,
shape memory alloy having circumferentially spaced substantially
smooth outer loops at the longitudinally spaced ends configured such
that heat causes the first center diameter to increase to the second
center diameter, and the elongated shape to contract longitudinally
and become axially compressed to the deployed shape such that each
of the spaced ends of the tube thermally deform and evert to form
substantially smooth petals when inserted into walls of two adjacent
lumens at a luminal interface of an anastomotic site, wherein the
petals are interdigitated, wherein the substantially smooth petals of the
deployed shape are configured to compress both lumen walls in a
manner directly opposed with each other which holds the luminal
interface of the anastomotic site in apposition, wherein the deployed
shape is substantially flat.
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The following ground of rejection is before us for review:
The Examiner has rejected claims 1, 2, 13, 14, 18, 19, and 24 under 35
U.S.C. § 103(a) as unpatentable over Kim
1
in view of Berg.
2

As Appellants do not argue the claims separately, we focus our
analysis on claim 1, and claims 2, 13, 14, 18, 19, and 24 stand or fall with
that claim. 37 C.F.R. § 41.37 (c)(1)(iv).

ISSUE
The Examiner takes the position that “Kim discloses an anastomotic
device comprising a woven tube of wire having an elongated shape and
constructed from a thermal, shape memory alloy.” (Ans. 3.) In addition,
Kim discloses a device “with the attribute of increasing diameter when
deployed in order to create a seal in the vessel wall.” (Id. at 4.) “Berg
teaches [use] of a similar anastomotic device comprises fingers that
interdigitate.” (Id. at 5.) The Examiner concludes that “it would have been
obvious to modify the anastomotic device of Kim with interdigitated petals
in order to increase the contact area between the petals, as well as the
compression of the tissue between the petals.” (Id.)
Appellants contend that “the Examiner failed to address that neither
Kim nor Berg teach an anastomotic device inserted into walls of two
adjacent lumens at a luminal interface of an anastomotic site in apposition,
and that neither Kim nor Berg teach a deployed shape that is substantially
flat.” (App. Br. 6, 8.)

1 Ducksoo Kim, US 6,007,544, issued Dec. 28, 1999.
2
Todd A. Berg et al., US 6,391,036 B1, issued May 21, 2002.
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The issues are: Based on the preponderance of the evidence of this
record has the Examiner presented a prima facie case and if so have
Appellants provided sufficient rebuttal evidence to overcome the prima facie
case?

FINDINGS OF FACT
1. Kim disclosed a device made of thermoelastic material that
increases in diameter once deployed. The device is illustrated below:

(Kim, Figure 32C) Figure 32C illustrates the completion of the
thermoelastic deformation of a thermoelastic cuff 300 that is open at each
end 302, 304, and results in flaired lip zones 314, 316 after deployment
(Kim, col. 23, l. 7 to col. 24, l. 32), were the central area of the cuff can stay
in unaltered form; or alternatively “the central section 310 can optionally be
made thermoelastically to increase in overall diameter slightly, if desired, in
order to hold the cuff more tightly and to seal the vessel wall” (Kim, col. 24,
ll. 29-32; Ans. 4).
2. Kim disclosed a thermoelastic cuff made of woven alloy having
petaloid shape. The cuff is illustrated below:
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(Kim, Figure 36C) Figure 36C illustrates a deployed cuff made of loose
woven alloy wires having a petaloid design. (Kim, col. 26, l. 59 to col. 27, l.
19; Ans. 3.)
3. Kim disclosed an anastomotic device that connects two arteries
to provide a bypass around an obstructed segment (Kim Abstract). An artery
anchoring segment of such a device is illustrated below:

(Kim, Figure 51) Figure 51 shows the thermal deformation and flairing, 308
and 312, of the cuff 300 in the sidewall 502 of an artery 500. (Kim, col. 39,
ll. 14-50; Ans. 5.)
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4. Berg disclosed that:
the fingers 14 extending from axially opposite ends of medial
portion 16 may be deflected and set so that their free ends
overlap. When a connector or plug made in this way is
installed in a patient, this construction of fingers 14 helps to
increase the contact area between fingers 14 and the tissue
between them, as well as compression of the tissue between the
fingers.
(Berg, col. 8, ll. 60-67; Ans. 5.)
5. Berg disclosed a device that is a hollow tube that can be used as
a connector or with a plug (Berg, col. 3, ll. 65-68). As illustrated below the
device contains fingers that grip the tissue structure:

(Berg, Figure 12.) Figure 12 shows the deployed device in a tissue structure
80, with the medical portion 16 having fingers 14 holding onto the tissue
structure from both sides, and in this case the device contains a plug 70.
(Berg, col. 6, ll. 52-65.) Depending on the intended use the medical portion
16 may range from 0.2 mm to about 4 mm in length. (Berg, col. 4, ll. 20-
30.)
5. The Specification provides that “Figure 4F shows the woven
tube in its deployed, flattened form gripping the walls of the lumens.”
(Spec. 4.)
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6. The Specification provides that “the tissues of both lumen walls
are compressed between the petals of the flattened tube (see Figure 1) with
the center diameter 12 of the flattened tube forming an opening between the
lumens.” (Spec. 5.)

PRINCIPLES OF LAW
“[A]pparatus claims cover what a device is, not what a device does.”
Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1468 (Fed.
Cir. 1990).

ANALYSIS
Appellants assert that neither Kim nor Berg teach an anastomotic
device inserted into the walls of two adjacent lumens. (App. Br. 7.)
Appellants assert that “the deployed structure of Kim is not substantially
flat” (id. at 8), and “the deployed shape of Berg remains a tube-shaped” (id.).
We are not persuaded by Appellants‟ arguments. We agree with the
Examiner‟s position, and find that the Specification does not provide a
specific definition of what is intended by the term “substantially flattened.”
The Specification provides that in the deployed form the device needs to
grip the walls of two lumens (FFs 5, 6). As explained by the Examiner:
It is noted that „substantially flat‟ is a relative term that differs
in scope from „flat‟. There is no special definition of the term in
the present specification. Examiner asserts that the device is
intended to conform to the thickness of a vessel wall 502 (Fig
51), so it can be considered „substantially flat‟. Additionally,
the thickness would be reduced depending on the thickness of
the vessel wall 502. Furthermore, the top and bottom surfaces
can be considered „substantially flat‟ similar to a table top.
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Applicant refutes this interpretation without providing any
reasoning to support the argument.
(Ans. 5-6.) Appellants have pointed to Figure 51 of Kim and Figures 4-5 of
Berg in support of their position that the references do not depict structures
that are substantially flat (App. Br. 8). We are not persuaded by Appellants‟
arguments that neither Kim nor Berg disclose structures that meet the
limitation of substantially flat. Appellants rely on comparing the drawings
provided in Kim and Berg in order to distinguish the claimed structure (id.).
We point out the figures presented in the references are not drawn to scale.
We find that both Kim and Berg disclose structures that are able to grip the
walls of a single vessel (FFs 3, 5). Although the drawings show that the
devices contain an illustrative gap between the flattened petals on either side
of the vessel wall, we note that in these illustrations the center of the device
represents the thickness of a single vessel wall (FFs 3, 5). The ordinary
artisan would recognize that the device spanning the thickness of a single
vessel has a midsection that is shorter than the midsection of a device
spanning two vessel walls. The term substantial
3
refers to “being largely but
not wholly that which is specified.” Thus, in terms of the present
application, we interpret “substantially flat” as encompassing not only the
thickness of a single vessel wall but the thickness of two vessel walls. Berg
recognizes that depending on where the device is to be deployed, the
midsection thickness of the device can be adjusted (FF 4).
We agree with the Examiner‟s position that the claims are directed to
a device and that the limitation “inserted into the walls of two adjacent

3
Merriam-Webster online dictionary, http://www.merriam-
webster.com/dictionary/substantial, accessed February 25, 2013.
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lumens at a luminal interface of an anastomotic site” recites an intended use.
“[T]he patentability of apparatus or composition claims depends on the
claimed structure, not on the use or purpose of that structure.” Catalina
Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir.
2002). Appellants have not provided any persuasive evidence to show that
this limitation imparts a structural limitation on the device. Furthermore,
Berg recognizes that “[t]he length of medial portion 16 may be selected
based on the intended use of the structure. For example, the length of
medial portion 16 may be selected to correspond to the thickness of the
patient's body tissue through which the medial portion will extend.” (Berg,
col. 4, ll. 20-25.)
Appellants assert that there is no motivation to combine the references
(App. Br. 8-9), and that Kim would be inoperable as an anastomotic device
because “Kim is directed to vascular occlusion device. Occlusion of a
passage is the opposite of what an anastomosis seeks to accomplish.” (Id. at
9.) “Kim lacks at least two characteristics of the claimed device: (1) a
second center diameter and (2) substantially smooth petals configured to
compress both lumen walls in a manner directly opposed with each other.”
(Id. at 9-10.)
We are not persuaded by these arguments as well. Kim is directed to
a “methodology for creating a bypass on-demand between an unobstructed
blood vessel such as the aorta and an obstructed blood vessel such as an
obstructed coronary artery in-vivo using a prepared shape-memory alloy cuff
and a graft segment in tandem as a shunt.” (Kim Abstract.) Thus, Kim is
directed at opening and creating blood flow across portions of blood vessels
that are blocked. The device of Kim is made up of woven mesh having petal
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like structures (FF 2). In addition, Kim also provides that the segment of the
device that is inside the vessel wall can increase in diameter to seal the
device with the vessel wall (FF 1). We agree with the Examiner that these
features of Kim would allow it to be operable for the intended use of the
claimed invention and find that Appellants have not provided any persuasive
evidence to the contrary.
Appellants assert that Kim teaches away from the combination
because “Kim teaches a cuff wherein one portion is partially positioned in
an internal lumen and another portion is „covering the exterior surface‟ of
an artery.” (App. Br. 10.) A prior art reference is said to teach away from
an Applicant‟s invention “when a person of ordinary skill, upon reading the
reference, would be discouraged from following the path set out in the
reference, or would be led in a direction divergent from the path that was
taken by the applicant.” In re Gurley, 27 F.3d 551, 553 (Fed. Cir.
1994). “The prior art‟s mere disclosure of more than one alternative does
not constitute a teaching away from any of these alternatives because such
disclosure does not criticize, discredit, or otherwise discourage the solution
claimed.” In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). Kim
disclosed that there are various arrangements to achieve coronary grafts,
these include “[u]sing both one-to-side and multiple, sequential, side-to-side
anastomoses.” (Kim col. 31, ll. 13-15.) Thus, contrary to Appellants
assertion, the disclosure of Kim would not lead the ordinary artisan away
from using side-to-side anastomosis for creating blood flow around a
blocked vessel.
We conclude that the preponderance of the evidence of record
supports the Examiner‟s conclusion that the combination of Kim and Berg
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renders obvious the anastomotic device of claim 1. We thus affirm the
rejection of claim 1 under 35 U.S.C. § 103(a) as being obvious. As claims 2,
13, 14, 18, 19, and 24 have not been argued separately and therefore fall
with that claim, we affirm the rejection as to these claims as well. 37 C.F.R.
§ 41.37(c)(iv).

SUMMARY
We affirm the rejection of claims 1, 2, 13, 14, 18, 19, and 24 under 35
U.S.C. § 103(a) as unpatentable over Kim in view of Berg.

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

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