Ex Parte Adams

Board of Patent Appeals and Interferences

Nov 28, 2011

10705127 (B.P.A.I. Nov. 28, 2011)

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.
10/705,127 11/12/2003 Ronald Adams 6530.0084-03 5622
22852 7590 11/29/2011
FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER
LLP
901 NEW YORK AVENUE, NW
WASHINGTON, DC 20001-4413
EXAMINER
WOO, JULIAN W
ART UNIT PAPER NUMBER
3773
MAIL DATE DELIVERY MODE
11/29/2011 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte RONALD ADAMS
____________

Appeal 2010-001216
Application 10/705,127
Technology Center 3700
____________

Before STEFAN STAICOVICI, EDWARD A. BROWN, and
CHARLES N. GREENHUT, Administrative Patent Judges.

STAICOVICI, Administrative Patent Judge.

DECISION ON APPEAL

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Application 10/705,127

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STATEMENT OF THE CASE
Ronald Adams (Appellant) appeals under 35 U.S.C. § 134 from the
Examiner’s decision rejecting claims 43, 45-51, 56, 59-67, and 70 under 35
U.S.C. § 102(b) as anticipated by or, in the alternative, under 35 U.S.C.
§103(a) as unpatentable over Hannam (US 5,649,959, issued Jul. 22, 1997),
and claims 52-55, 68, 69, and 71 under 35 U.S.C. § 103(a) as unpatentable
over Hannam and Diaz (US 5,690,674, issued Nov. 25, 1997). Claims 1-42,
44, 57, and 58 have been canceled. Appellant’s representative presented
oral argument on Nov. 17, 2011. We have jurisdiction over this appeal under
35 U.S.C. § 6.

THE INVENTION
Appellant’s invention relates in an embodiment to an implantable
tissue fastener 20c for fastening layers of tissue between a distal anchor
member 30c and a proximal anchor member 40c. Spec. 3: 7-8; 16: 20-22;
and fig. 14.
Claim 43 is representative of the claimed invention and reads as
follows:
43. A system for treating gastroesophageal reflux disease, the
system comprising:
a fastener configured to hold the wall of the esophagus and the
gastric wall together,
wherein a portion of the system comprises at least one outlet for
flow communication with a source containing an adhesive inducing
agent, wherein the portion is configured to introduce the adhesive
inducing agent between the wall of the esophagus and the gastric wall,
wherein at least one part of the fastener is expandable, in a
direction transverse to a length of the fastener, from a reduced profile
position to an expanded profile position,
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wherein the fastener comprises a material that degrades in a
body,
wherein the fastener comprises a proximal anchor member and
a distal anchor member,
wherein one of the proximal and distal anchor members is
configured to be placed against an inner surface of the wall of the
esophagus and the other of the proximal and distal anchor members is
configured to be placed against an inner surface of the gastric wall to
hold the wall of the esophagus and the gastric wall together with the
wall of the esophagus and the gastric wall being sandwiched in-
between the proximal and distal anchor members, and
wherein the fastener lacks an inflatable balloon.

SUMMARY OF DECISION
We REVERSE.
ANALYSIS
Claims 43, 45-51, 56, 59-67, and 70
The anticipation rejection
Each of independent claims 43 and 56 requires, inter alia, “a fastener
configured to hold the wall of the esophagus and the gastric wall together …
with the wall of the esophagus and the gastric wall being sandwiched in-
between the proximal and distal anchor members.”
The Examiner found that Hannam describes a fastener including a
proximal anchor 36 (filament member) or 52 (gelatinous material) and distal
anchor member 30 (anchor member). Ans. 3 (parenthetical nomenclature to
Hannam). The Examiner further found that the fastener of Hannam ”is
capable of being used as claimed if one desires to do so.” Ans. 4. In other
words, the Examiner appears to take the position that because the fastener of
Hannam is capable of sealing an opening in an organ of a patient, it can also
hold the esophagus and gastric walls together. Ans. 5.
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We find the Examiner’s position to be mere speculation and
conjecture based on an unfounded assumption that the fastener of Hannam is
capable of holding the esophagus and gastric walls together, as called for by
independent claims 43 and 56.
At the outset, we find that Hannam describes a device 20 for sealing
an incision 28 in the body of a patient, i.e., artery 24. Hannam, Abstract and
figs. 4-6. The device 20 of Hannam includes, inter alia, a filament member
36 that penetrates a percutaneous opening and positions an anchor member
30 adjacent incision (hole) 28 in artery 24. A gelatinous material 52 is
injected along filament member 36 to seal the incision 28 and the
percutaneous opening. Hannam, col. 7, ll. 3-21; col. 8, ll. 16-25; and fig. 9.
As such, in contrast to the claimed invention, which requires tissue walls to
be held together, device 20 of Hannam merely seals an opening in a tissue
wall. See Hannam, fig. 21. Further, since filament member 36 is described
as a flexible or semi-rigid member (see Hannam, col. 7, ll. 64-67), we do not
see how it can be capable to sandwich and hold tissue walls together in
conjunction with anchor member 30. Similarly, since gelatinous material 52
is described as “a slightly viscous material, a suspension or a paste” that
merely fills the incision 28 (see Hannam, col. 6, ll. 39-41), we do not see
how gelatinous material 52 is capable of sandwiching and holding tissue
walls together in conjunction with anchor member 30. The Examiner has
not adequately articulated how the fastener of Hannam would function to
sandwich and hold tissue walls together in the manner claimed. Finally,
with respect to Figure 21 of Hannam (see Ans. 6), although we appreciate
that the tissue wall of artery 24 is sandwiched and held between gelatinous
material 52 and anchor member 30, nonetheless, Hannam discloses merely
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sealing an opening in a tissue wall and not sandwiching and holding tissue
walls together as claimed.
As such, we agree with Appellant that, “Hannam never refers to any
walls or organs being held together or any structure that holds walls
together.” Reply Br. 2. Hence, for the foregoing reasons, we find that the
Examiner has not provided a reasonable basis to conclude that the fastener
of Hannam is capable of holding the esophagus and gastric walls together, as
called for by independent claims 43 and 56. Therefore, the rejection of
claims 43, 45-51, 56, 59-67, and 70 under 35 U.S.C. § 102(b) as anticipated
by Hannam cannot be sustained.

The obviousness rejection
As an alternative, the Examiner opines that, “Hannam et al. do not
specifically disclose a fastener ‘configured to hold the wall of the esophagus
and the gastric wall together’.” Ans. 4. However, according to the
Examiner, because Hannam discloses that “the fastener is applicable to
‘body organs, cavities, or tissue’ as well as an ‘other body duct or lumen’ …
[i]t would have been a matter of obvious design choice to configure or size
the fastener of Hannam et al., so that it is applicable to hold the wall of the
esophagus and the gastric wall together.” Id.
In this case, we find the Examiner’s rejection insufficient to explain
what in the prior art would have prompted a person having ordinary skill in
the art to modify Hannam’s fastener as articulated by the Examiner.
Specifically, it is not clear to us how the Examiner is proposing to modify
the fastener of Hannam. Furthermore, we find inadequate the reason
proposed by the Examiner to explain why one of ordinary skill in the art
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might have modified Hannam’s fastener. Just because Hannam’s fastener is
capable of sealing an opening in any body organ, tissue, cavity, or lumen,
without explaining how a person of ordinary skill would specifically modify
Hannam’s fastener, it is not clear that Hannam’s fastener is capable of also
sandwiching and holding together tissue walls as claimed.
Without an articulated rationale based on rational underpinning for
modifying the reference as proposed, the Examiner's rejection appears to be
the result of hindsight analysis. See In re Kahn, 441 F.3d 977, 988 (Fed.
Cir. 2006) (cited with approval in KSR Int'l Co. v. Teleflex Inc., 550 U.S.
398, 418 (2007)) ("rejections on obviousness grounds cannot be sustained by
mere conclusory statements; instead, there must be some articulated
reasoning with some rational underpinning to support the legal conclusion of
obviousness"). Thus, the Examiner has not made the initial factual findings
required to demonstrate a prima facie case of obviousness of independent
claims 43 and 56. See In re Warner, 379 F.2d 1011, 1017 (CCPA 1967) (the
examiner has the initial duty of supplying the requisite factual basis and may
not, because of doubts that the invention is patentable, resort to speculation,
unfounded assumptions, or hindsight reconstruction to supply deficiencies in
the factual basis). Hence, we cannot sustain the rejection of independent
claims 43 and 56 and their respective dependent claims 45-51, 59-67, and 70
under § 103 as unpatentable over Hannam. See In re Fine, 837 F.2d 1071,
1076 (Fed. Cir. 1988).

Claims 52-55, 68, 69, and 71
Independent claim 52 requires, inter alia, “a fastener configured to
hold the wall of the esophagus and the gastric wall together … wherein the
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at least one expandable part of the fastener is configured to … hold the wall
of the esophagus and the gastric wall sandwiched together.” The Examiner
takes the position that the fastener of Hannam is capable of holding the
esophagus and gastric walls sandwiched together. Ans. 4. However, for the
reasons discussed above we do not find that the fastener of Hannam is
capable to “hold the wall of the esophagus and the gastric wall sandwiched
together,” as called for by claim 52. The addition of Diaz does not remedy
the deficiency of Hannam as discussed above. Accordingly, the rejection of
independent claim 52 and its dependent claims 53-55, 68, 69, and 71 under
§ 103 as unpatentable over Hannam and Diaz likewise cannot be sustained.
See In re Fine, 837 F.2d at 1076.

SUMMARY
The decision of the Examiner to reject claims 43, 45-56, and 59-71 is
reversed.

REVERSED

mls