Ex Parte Hartwick et al

Patent Trial and Appeal Board

Apr 30, 2013

10746549 (P.T.A.B. Apr. 30, 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.
10/746,549 12/24/2003 Darrell Hartwick 10121/01801 4765
7590 04/30/2013
Patrick J. Fay, Esq.
FAY KAPLUN & MARCIN, LLP
Suite 702
150 Broadway
New York, NY 10038
EXAMINER
EREZO, DARWIN P
ART UNIT PAPER NUMBER
3773
MAIL DATE DELIVERY MODE
04/30/2013 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 DARRELL HARTWICK,
MALKA BERNDT, and GEORGE NUNEZ
__________

Appeal 2011-013219
Application 10/746,549
Technology Center 3700
__________

Before DONALD E. ADAMS, ERICA A. FRANKLIN, and
SHERIDAN K. SNEDDEN, Administrative Patent Judges.

FRANKLIN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
system and apparatus for performing endoluminal anastomosis of an organ.
The Patent Examiner rejected the claims as obvious. We have jurisdiction
under 35 U.S.C. § 6(b). We reverse.
STATEMENT OF THE CASE
Claims 1-7, 13-17, 19 and 20 are on appeal. Claim 1 is representative
and reads as follows:

Appeal 2011-013219
Application 10/746,549

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1. A system for endoluminally performing an anastomosis of a
substantially tubular organ, the system comprising:

a flexible endoscope;

an operative head slidably mountable on the endoscope, the operative
head including a stapling mechanism and an anvil moveable relative to one
another to define a tissue receiving space therebetween and a tissue cutting
mechanism extending into the tissue receiving space proximal of the stapling
mechanism, the stapling mechanism and the anvil being coupled to one
another so that all components thereof remain within a lumen of the organ at
all times during the anastomosis, the operative head further comprising:

the tissue cutting mechanism formed as a substantially
cylindrical element having a cylindrical side wall, a proximal end wall
and a sharpened distal rim;

a staple driver ring formed as a substantially cylindrical
element, wherein the tissue cutting mechanism is configured to be
movable independently of the staple driver ring; and

a tissue gripping mechanism for drawing tissue from the organ into
the tissue receiving space, wherein the portion of tissue drawn into the tissue
receiving space extends around a complete circumference of the organ;

wherein, operation of the stapling mechanism drives staples through a
portion of tissue received within the tissue receiving space around the entire
circumference thereof and, operation of the tissue cutting mechanism severs
from the tissue through which the staples were driven a portion of tissue
located within the tissue receiving space separated proximally therefrom.

Appeal 2011-013219
Application 10/746,549

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The Examiner rejected claims 1-7, 13-17, 19 and 20 under 35 U.S.C.
§ 103(a) as unpatentable over Schnut,
1
Adams,
2
and Vaitekunas.
3

OBVIOUSNESS
The Examiner‟s position is that Schnut disclosed a system for
endoluminally performing an anastomosis of a substantially tubular organ,
the system comprising each element of independent claim 1, except for: a
flexible endoscope, the operative head slidably mountable on the endoscope,
a tissue gripping mechanism for drawing tissue from the organ into the
tissue receiving space, and wherein the tissue cutting mechanism is
configured to be movable independently of the staple driver ring. (Ans. 3-
4.)
However, the Examiner found that Adams disclosed a similar system
for performing an anastomosis of a tubular organ, wherein the system
includes an endoscope lumen for receiving an endoscope with an operative
head, and a tissue gripping mechanism for drawing tissue. (Id.)
According to the Examiner, it would have been obvious to a person of
ordinary skill in the art at the time the invention was made to have modified
the system of Schnut “to include the use of an endoscope and a tissue
gripper mechanism since the endoscope would provide a visual guide for the
system while the tissue gripper mechanism would positively secure the loose
tissue ends within the tissue receiving space.” (Id.)

1
US Patent No. 5,588,579 issued to Robert H. Schnut et al., Dec. 31, 1996.
2
US Patent No. 6,126,058 issued to Ronald D. Adams et al., Oct. 3, 2000.
3
US Patent No. 6,004,335 issued to Jeffrey J. Vaitekunas et al., Dec. 21,
1999.
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Application 10/746,549

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Additionally, the Examiner found that Vaitekunas discloses a surgical
device having a handle comprising two levers, wherein one lever was used
to separately control a cutting device. (Id. at 5.) Therefore, the Examiner
concluded that it would have been obvious to a person of ordinary skill in
the art at the time the invention was made to have modified Shnut‟s device
to have a separate actuator for the cutting means to allow the surgeon to
control the stapling device and the cutting mechanism independently. (Id.)
Appellants contend that “Schnut fails to teach or suggest „[a] system
for endoluminally performing an anastomosis of a substantially tubular
organ,‟ as recited in claim 1[,] and has little relevance to devices operating
endoluminally.” (App. Br. 6.) Appellants assert “that an endoluminal
procedure is distinguished from „open‟ procedures and requires that the
entire procedure takes place within the lumen.” (Reply Br. 4.) Appellants
assert that their “Specification specifically describes the disadvantages of
resection devices which require an incision and details an apparatus for
performing endoluminal anastomosis to overcome these disadvantages.”
(Id.)(citing Spec. [0003]). According to Appellants, Schnut is configured for
open surgical, end-to-end anastomoses wherein the anvil is inserted from a
first surgical opening to rest within a previously cut portion of the intestine,
while the fastener assembly, i.e., stapling mechanism, is inserted into a
second portion of the intestine and positioned to align with the anvil to draw
the first and second portions of the intestine toward one another for stapling.
(Id. at 6-7.) Thus, Appellants assert that Schnut‟s separate structures of the
anvil and the fastener assembly are configured to operate through incisions
formed in the body and are incapable of use in an endoluminal procedure.
(Id.)
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Additionally, Appellants assert that there is no teaching, suggestion or
motivation for combining the open anastomosis device of Schnut, directed to
a system for performing an open anastomosis, with the endoluminal device
of Adam, which teaches an endoluminal procedure. (Id. at 7.) According to
Appellants, Schnut has no need for: an endoscope; the operative head of its
device to be slidably mountable on the endoscope; or a tissue gripping
mechanism for drawing tissue within a tissue receiving space between the
fastener assembly and the anvil. (Id.)
Further, Appellants assert that Schnut provides no motivation for
combining the two lever control element of Vaitekunas to provide Schnut
with a tissue cutting mechanism to be movable independently of the staple
driver ring. (Id. at 8-9.) Moreover, according to Appellants, Schnut cannot
be modified to include this element of Vaitekunas because the independent
movement in the Vaitekunas device is only permitted due to the planar shape
of its cutting element and the shape of its jaw members. (Id. at 9.)
Appellants assert that such a movement would not be permissible in Schnut
which has a cylindrical cutting mechanism and cylindrical staple driver ring.
(Id.) Additionally, Appellants assert that it is unclear how the two-lever
system of Vaitekunas would be incorporated into the device of Schnut as
Schnut‟s knife member cannot be modified to be movable relative to the
staple pushers due to its engagement with the wall of the anvil connecting
member. (Id.)
After considering all the evidence and arguments, we conclude that
the record does not support a conclusion of prima facie obviousness for the
reasons discussed by Appellants. In particular, we find that the Examiner
has not adequately explained how the device in Schnut is reasonably related
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Application 10/746,549

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to a system for endoluminally performing an anastomosis and why a skilled
artisan would have been motivated to modify Schnut‟s circular stapler
instrument designed for use in an open surgery (see Schnut col. 1, ll. 10-12)
to include an endoscope so as to “provide a visual guide for the system”
(Ans. 4).
Accordingly, we reverse the Examiner‟s obviousness rejection. See
Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966)(The question of
obviousness is resolved on the basis of underlying factual determinations
including, the scope and content of the prior art, and any differences
between the claimed subject matter and the prior art.)
SUMMARY
We reverse the rejection of claims 1-7, 13-17, 19 and 20 under 35
U.S.C. § 103(a) as unpatentable over Schnut, Adams, and Vaitekunas.

REVERSED

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