Ex Parte Saadat et al

Patent Trial and Appeal Board

Oct 4, 2012

10898683 (P.T.A.B. Oct. 4, 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.
10/898,683 07/23/2004 Vahid Saadat USGINZ02800 2870
7590 10/05/2012
USGI Medical, Inc.
1140 Calle Cordillera
San Clemente, CA 92673
EXAMINER
NGUYEN, TUAN VAN
ART UNIT PAPER NUMBER
3731
MAIL DATE DELIVERY MODE
10/05/2012 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 AND TRIAL APPEAL BOARD
__________

Ex parte VAHID SAADAT and DESMOND BIRKETT
__________

Appeal 2011-012097
Application 10/898,683
Technology Center 3700
__________

Before DEMETRA J. MILLS, JEFFREY N. FREDMAN, and
ULRIKE W. JENKS, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
for achieving prolonged maintenance of gastrointestinal tissue folds. The
Examiner rejected the claims as obvious. We have jurisdiction under 35
U.S.C. § 6(b). We affirm.

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Statement of the Case
“The present invention relates to methods and apparatus for achieving
prolonged maintenance of gastrointestinal („GI‟) tissue folds by forming,
securing and promoting healing of the folds. More particularly, the present
invention provides methods and apparatus for remodeling the tissue folds to
facilitate their prolonged maintenance” (Spec. 1 ¶ 0001).
The Claims
Claims 16-22, 24-30, and 32-35 are on appeal. Claim 16 is
representative and reads as follows:
16. A method for achieving prolonged maintenance of
gastrointestinal tissue folds, the method comprising:
injuring at least a first region of tissue to be
approximated against a second region of tissue;
removing at least a portion of injured tissue from
the first region to be approximated;
contacting the first region of tissue against the
second region of tissue to promote healing between the
first and second regions of tissue; and
deploying an anchor assembly comprising a pair of
tissue anchors connected by a suture through the first
region of tissue and the second region of tissue to secure
the first region of tissue to the second region of tissue.

The issue

The Examiner rejected claims 16-22, 24-30, and 32-35 under 35
U.S.C. § 103(a) as obvious over Deem
1
(Ans. 3-5).
The Examiner finds that Deem teaches “a method for performing
gastric reduction, the method comprising: forming anterior and posterior

1
Deem et al., US 6,558,400 B2, issued May 6, 2003.
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tissue folds within a patient‟s stomach (col. 10, lines 29-37 and lead line 24
of Figs. 8A-8B)” (Ans. 3). The Examiner finds that Deem teaches injuring
“tissue disposed between the anterior and posterior tissue folds;
approximating the anterior and posterior tissue folds such that the
approximated tissue folds contact one another in a region of injured or
removed tissue, thereby promoting healing between the at least two tissue
folds” (id.). The Examiner finds that Deem teaches that “stapler 172 is used
to forms [sic] the lumen 26 of Figs. 8A and 8B and the side surface of
septum 184 of stapler 172 includes „a cutting, abrading, scoring, heating,
freezing, chemically damaging, or s[o]me other damaging surface to tissue”
(id.).
Appellants contend that “the only tissue injuring process described by
Deem is performed by a particular embodiment of the stapling unit (172),
and is performed only during a portion of the process in which first and
second portions of the stomach are brought into apposition . . . prior to staple
deployment” (App. Br. 13). Appellants also contend that “the only anchor
deployment process described by Deem is performed by deploying the
anchors (80) into tissue prior to drawing a suture (82) tight to bring the
opposing surfaces into apposition” (id.). Appellants contend that “[n]owhere
is there any description, suggestion, or hint of a method that would include
both injuring tissue and deploying an anchor assembly - which is what is
recited in claim 16. Nor is there any obvious manner by which these method
steps would be combined” (id.).
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The issue with respect to this rejection is: Does the evidence of record
support the Examiner‟s conclusion that Deem renders claims 16 and 26
obvious?
Findings of Fact
1. Deem teaches that “an endoscopic stapler preferably brings two
regions of tissue into apposition and may then apply a fastening element,
e.g., staples, clips, tags, screws, etc., into the two regions of tissue to affix
them together” (Deem, col. 4, ll. 21-26).
2. Figure 8B of Deem is reproduced below:

Figure 8B shows “a superior view of a modified stomach maintained by a
fastening staple” (Deem, col. 5, ll. 44-45).
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3. Deem teaches that:
FIG. 8A shows the cross sectioned superior view of FIG. 1B
with the addition of staple 160 maintaining junction 24. The
figure shows an example of how, e.g., an endoscopically
applied stapler, may be used to retain and hold junction 24
to form modified lumen 26. FIG. 8B shows a close-up view
of the junction 24 and staple 160 which was applied from
within lumen 26.

(Deem, col. 10, ll. 32-38.)
4. Deem teaches that as “the tissue is held to unit 172, septum 184
may be withdrawn . . . . Removal of septum 184 may then bring the first and
second portions of tissue into contact apposition. The side surfaces 188 of
septum 184 may incorporate a cutting, abrading, scoring, heating, freezing,
chemically damaging, or some other damaging surface to tissue” (Deem, col.
11, ll. 33-41).
5. Deem teaches that this “damage may encourage a more
vigorous healing response and a more permanent fixation between the
damaged tissue once stapled or affixed together” (Deem, col. 11, ll. 43-46).
6. Deem teaches that “[a]fter removal of septum 184, the staples
loaded within staple enclosure 176 may be fired through staple slots 180 to
affix the tissue” (Deem, col. 11, ll. 47-49).
7. Deem teaches an embodiment where after “anchors 80 have
been fastened, suture 82 may be drawn through each of the anchors 80,
preferably in a zig-zag manner, and then suture 82 may be drawn tight to
bring the opposing surfaces of interior lining 74 together in apposition along
dye marks 72 to form the modified lumen” (Deem, col. 9, ll. 11-16).
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8. Deem teaches that as “pusher sleeve 456 advances, it may also
push or urge elastic ring 458 distally along inner tube 452 until ring 458 is
pushed entirely off the distal end of inner tube 452 and onto a portion of
lining tissue 466” (Deem, col. 19, ll. 18-21).
9. Figures 27A-D are reproduced below:

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“FIGS. 27A to 27D show the device . . . inserted into a stomach to draw or
cinch up lining tissue to reduce a volume of the stomach” (Deem, col. 6, ll.
47-49).
10. Deem teaches that “[d]evice 450 may then be removed from
stomach 460 . . . thereby leaving lining tissue 466 with elastic ring 458.
After time . . . pressure necrosis may cause lining tissue 466 and ring 458 to
simply fall off from the rest of interior surface 464 to be passed normally
through the rest of the patient‟s body” (Deem, col. 19, ll. 22-27).
11. Deem teaches that as “bougie 40 is advanced down to pylorus
76, distal balloon 52 may be inflated through inflation tip 50, thus securing
the device” (Deem, col. 8, ll. 33-35).
Principles of Law
“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). “If a person of
ordinary skill can implement a predictable variation, § 103 likely bars its
patentability.” Id. at 417.
Analysis
Claim 16
Deem teaches that “an endoscopic stapler preferably brings two
regions of tissue into apposition and may then apply a fastening element,
e.g., staples, clips, tags, screws, etc., into the two regions of tissue to affix
them together” (Deem, col. 4, ll. 21-26; FF 1).
Deem specifically teaches an example where “the tissue is held to unit
172, septum 184 may be withdrawn . . . . Removal of septum 184 may then
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bring the first and second portions of tissue into contact apposition. The side
surfaces 188 of septum 184 may incorporate a cutting, abrading, scoring,
heating, freezing, chemically damaging, or some other damaging surface to
tissue” (Deem, col. 11, ll. 33-41; FF 4). The Examiner finds that during “the
process of abrading, cutting the tissue, some of the tissue will be removed or
shed, thus, Deem et al. discloses the step of removing injured tissue” (Ans.
4). Deem teaches that this “damage may encourage a more vigorous healing
response and a more permanent fixation between the damaged tissue once
stapled or affixed together” (Deem, col. 11, ll. 43-46; FF 5).
While the embodiment of figures 8 and 9 relies upon the use of a
stapler, Deem teaches a separate embodiment where after “anchors 80 have
been fastened, suture 82 may be drawn through each of the anchors 80,
preferably in a zig-zag manner, and then suture 82 may be drawn tight to
bring the opposing surfaces of interior lining 74 together in apposition along
dye marks 72 to form the modified lumen” (Deem, col. 9, ll. 11-16; FF 7).
Applying the KSR standard of obviousness to the findings of fact, we
conclude that the person of ordinary skill and creativity would have
predictably recognized that when Deem teaches that the stapler affixes two
regions of tissue in apposition using a “fastening element” where the
“fastening element” may be selected from a nonexclusive list of components
(FF 1), and Deem separately teaches affixing two regions of tissue using
anchors and a suture (FF 7), the ordinary artisan would have found it
obvious to use the anchors and suture as a fastening element in the stapler
embodiment. Such a combination is merely a “predictable use of prior art
elements according to their established functions.” KSR, 550 U.S. at 417.
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Appellants contend that “the only tissue injuring process described by
Deem is performed by a particular embodiment of the stapling unit (172),
and is performed only during a portion of the process in which first and
second portions of the stomach are brought into apposition . . . prior to staple
deployment” (App. Br. 13). Appellants also contend that “the only anchor
deployment process described by Deem is performed by deploying the
anchors (80) into tissue prior to drawing a suture (82) tight to bring the
opposing surfaces into apposition” (id.). Appellants contend that “[n]owhere
is there any description, suggestion, or hint of a method that would include
both injuring tissue and deploying an anchor assembly - which is what is
recited in claim 16. Nor is there any obvious manner by which these method
steps would be combined” (id.).
We are not persuaded. Deem teaches that the regions placed in
apposition may be joined by a variety of different fastening elements,
including “e.g., staples, clips, tags, screws, etc., into the two regions of tissue
to affix them together” (Deem, col. 4, ll. 24-26; FF 1). Deem also teaches an
additional mode of fastening where “suture 82 may be drawn through each
of the anchors 80, preferably in a zig-zag manner, and then suture 82 may be
drawn tight to bring the opposing surfaces of interior lining 74 together in
apposition along dye marks 72 to form the modified lumen” (Deem, col. 9,
ll. 11-16; FF 7).
In Icon, the Court found that
an inventor considering a hinge and latch mechanism for
portable computers would naturally look to references
employing other “housings, hinges, latches, springs, etc.,”
which in that case came from areas such as “a desktop
telephone directory, a piano lid, a kitchen cabinet, a washing
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machine cabinet, a wooden furniture cabinet, or a two-part
housing for storing audio cassettes.”

In re ICON Health and Fitness, Inc., 496 F.3d 1374, 1380 (Fed. Cir. 2007)
(citing In re Paulsen, 30 F.3d 1475, 1481 (Fed.Cir. 1994). The instant
situation is similar to that of Icon and Paulsen, since in the instant case an
ordinary practitioner considering different fastening elements to join two
tissue regions would have reasonably considered all of the different
attachment mechanisms disclosed by Deem, which includes the use of
anchors and sutures (FF 7).
Claim 26
Appellants contend that “claim 26 recites a method including the step
of „shapelocking the device.‟ The Office Action does not identify any
teaching in the Deem patent corresponding with this limitation in its
rejection of claim 26” (App. Br. 16).
The Examiner finds that in “col. 8, lines 2-54, Deem et al. disclose a
marking device or Bougie 40 preferably be used at the beginning of the
procedure and using a distal balloon 52 to securing the device before
delivering of the die [sic dye]. The step of securing the Bougie 40 is
interpreted as shape-locking the device” (Ans. 8).
We find the Examiner has the better position. While the Specification
does not directly define the term “shape-lockable,” the Specification does
state that “[o]ne or more of the tools optionally may be steerable or shape-
lockable/rigidizable” (Spec. 4 ¶ 0016). Thus, we interpret shape-lockable to
be equivalent to “rigidizable,” so that the term is reasonably interpreted as
broadly requiring that the tool may be secured in a rigid form. Deem teaches
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that after balloon 52 is inflated, the bougie is secured to a particular location,
which securing reasonably makes the bougie “rigid” relative to its previous
unsecured state (FF 11). Because claim 26 is of the open “comprising”
format, the first two steps of claim 26 may reasonably refer to the insertion
and securement of the bougie 40, with the remaining steps referring to the
formation of anchored tissue folds as discussed above regarding claim 16.
Conclusion of Law
The evidence of record supports the Examiner‟s conclusion that Deem
renders claims 16 and 26 obvious.
SUMMARY
In summary, we affirm the rejection of claims 16 and 26 under 35
U.S.C. § 103(a) as obvious over Deem. Pursuant to 37 C.F.R. § 41.37(c)(1),
we also affirm the rejection of claims 17-22, 24, 25, 27-30, and 32-35 as
these claims were not argued separately.

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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