Ex Parte Tsonton et al

Patent Trial and Appeal Board

Nov 13, 2012

11798632 (P.T.A.B. Nov. 13, 2012)

UNITED STATES PATENT AND TRADEMARKOFFICE
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.
11/798,632 05/15/2007 Mark Tsonton END-6046 6325
21884 7590 11/13/2012
WELSH FLAXMAN & GITLER LLC
2000 DUKE STREET, SUITE 100
ALEXANDRIA, VA 22314
EXAMINER
DORNA, CARRIE R
ART UNIT PAPER NUMBER
3735
MAIL DATE DELIVERY MODE
11/13/2012 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 TRIAL AND APPEAL BOARD
__________

Ex parte MARK TSONTON and DANIEL J. MUMAW
__________

Appeal 2012-000418
Application 11/798,632
Technology Center 3700
__________

Before JEFFREY N. FREDMAN, ERICA A. FRANKLIN, 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 balloon-
type gastric band. The Examiner rejected the claims as obvious. We have
jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part.

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Statement of the Case
Background
The Specification teaches a “balloon-type gastric band . . .
dimensioned to circumscribe the stomach at a predetermined location. The
balloon includes a longitudinally extending body” (Spec. 5). According to
the Specification, a “supply tube is secured to the balloon for fluid
communication with an internal cavity of the balloon, wherein the supply
tube includes a valve controlling the flow of fluid to and from the balloon”
(Spec. 5).
The Claims
Claims 1-6, 8-15, and 17-22 are on appeal. Claim 1 is representative
and reads as follows:
1. A balloon-type gastric band, comprising:
a balloon shaped and dimensioned to circumscribe the
stomach at a predetermined location;
the balloon includes a longitudinally extending body;
a supply tube including a distal end and a proximal
end, the distal end of the supply tube being secured to the
balloon for fluid communication with an internal cavity of
the balloon, wherein the proximal end of the supply tube
includes a valve controlling the flow of fluid to and from the
balloon, a locking connector integrated with the valve,
wherein the locking connector is shaped and dimensioned
for selective connection to a fluid injection port.

The issue
The Examiner rejected claims 1-6, 8-15, and 17-22 under 35 U.S.C. §
103(a) as obvious over Stephens1 and Haber2 (Ans. 4-13).

1 Stephens et al., US 2004/0254625 A1, published Dec. 16, 2004.
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The Examiner finds that:
Stephens et al. teaches a balloon-type gastric band,
comprising: a balloon (Figure 17A, inner bladder, 542)
shaped and dimensioned to compress the stomach at a
predetermined location ([0110]-[0111]); the balloon includes
a longitudinally extending body; and a valve (Figure 17C,
fill valve, 550) controlling the flow of fluid to and from the
balloon, wherein the valve is shaped and dimensioned for
selective connection to a fluid injection port.

(Ans. 4). The Examiner finds that “Stephens et al. teaches another
embodiment of the valve . . . and fluid injection port (Figure 14A-14B, filler-
retainer member, 504) comprising a locking connector (Figure 14A-14B,
extensions, 505 pass through openings, 506) integrated with the valve” (Ans.
5).
The Examiner finds that “Haber teaches a balloon-type gastric band,
comprising: a longitudinally-extending balloon (Figure 1, chamber, 2)
shaped and dimensioned to compress the stomach at a predetermined
location (col. 3, lines 8-22); and a supply tube (Figure 1, tubing, 8, 12, and
22-1) including a distal end and a proximal end” (Ans. 5). The Examiner
finds it obvious to “modify the shape and dimensions of the balloon of
Stephens et al. such that it may circumscribe a stomach as taught by Haber,
because circumscribing a body lumen versus partially encircling the lumen
to provide occlusive pressure provides improved flow control” (Ans. 5-6).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that Stephens and Haber render
claims 1, 2, 5, 11, 12, 20, and 21 obvious?

2 Haber, T., US 4,634,443, issued Jan. 6, 1987.
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Findings of Fact
The following findings of fact (“FF”) are supported by a
preponderance of the evidence of record.
1. Stephens teaches an inflatable implant having a shape which
“may be used in those situations where an additional measure of turgor or
support is needed, for instance, at a sphincter muscle controlling a bodily
fluid flow or direction. This implant may be used (with proper sizing and
adjustment of the respective bladder compositions, etc.) in treating such
maladies as gastroesophageal reflux disease” (Stephens 8 ¶ 0110).
2. Figure 17A of Stephens is reproduced below:

“FIG[] 17 A . . . depict[s] side and end views of an implant (540) having
multiple independent bladder or bladder volumes” (Stephens 8 ¶ 0110).
3. Stephens teaches “fill valves (inner 550, outer 552). A filler
member (554) is also depicted that may be used to independently fill the two
bladders” (Stephens 9 ¶ 0112).
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4. Stephens teaches that:
The filler-retainer member (504) in this example of the
implant assembly has the functions of holding the implant
(501) in place by interference of the extensions (505) in
openings (506) during the step of placement at the treatment
site, of holding the implant (501) in place at the end of the
delivery member (503) during the filling step (after the
optional outer sleeve (502) has been withdrawn), and of
acting as a passageway for the filling materials (508) during
expansion of the implant (501) bladder.

(Stephens 8 ¶ 0104).
5. Stephens teaches “one or more optional one-way valves form
the passageway through the bladder wall permitting flow into the interior
bladder volume and preventing filler material flow out of the volume once
either the bladder volume is filled or the introducer device is removed from
the one way valves” (Stephens 10-11 ¶ 0130).
6. Haber teaches that “the occlusion cuff 1 is adapted to embrace
and occlude a lumen, such as, for example, the bowel of a patient who has
undergone a colostomy . . . However, it is also to be understood that the
present sphincter is also applicable to any other suitable lumen, such as the
urethra, the esophagus, a vein, an artery or the vas deferins” (Haber, col. 3,
ll. 4-11).
7. Haber teaches that a “first section of tubing 8 extends between
an inlet/outlet 50 of occlusion cuff 1 and a tube connector 10 arranged in the
primary fluid path 6. . . A second section of tubing 12 of the primary fluid
path 6 extends between connector 10 and a normally closed, manually
manipulatable flow control valve 14” (Haber, col. 3, ll. 50-61).

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8. Figure 1 of Haber is reproduced below:

“FIG. 1 is a front elevation of the gastrointestinal sphincter and the single,
continuous fluidic circuit thereof which form the present invention” (Haber,
col. 2, ll. 38-40).
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. As noted by the Court in KSR,
“[a] person of ordinary skill is also a person of ordinary creativity, not an
automaton.” 550 U.S. at 421.

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Analysis
Claims 1 and 11
We begin with claim interpretation. Claim 1 has a preamble in which
the product is identified as a “gastric band”. However, a preamble is not
limiting “where a patentee defines a structurally complete invention in the
claim body and uses the preamble only to state a purpose or intended use for
the invention.” Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d
801, 808 (Fed.Cir.2002). In the instant case, Claim 1 defines a complete
invention in the claim body, where the product is fully described as a
balloon with specific characteristics and a supply tube, valve and locking
connector connected to the balloon. Therefore, the preamble of claim 1 is
not found to limit the claim.
Claim 1 also requires that a “balloon shaped and dimensioned to
circumscribe the stomach at a predetermined location”. The sizing and
dimension language impose no further specific requirements on the balloon,
particularly given that the balloon may be reasonably employed on widely
varying sized stomachs and at different locations of the stomach. We
therefore broadly interpret this phrase to encompass the balloons of Stephens
and Haber, which are both taught as occlusion devices for lumens, including
those as large as the bladder (FF 1) and esophagus (FF 6). See In re Zletz,
893 F.2d 319, 322 (Fed. Cir. 1989) (“[D]uring patent prosecution when
claims can be amended, ambiguities should be recognized, scope and
breadth of language explored, and clarification imposed.”)
Stephens teaches a balloon which is shaped and dimensioned to
circumscribe a body lumen (FF 1) where the balloon includes a
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longitudinally extending body (FF 2) and where the balloon is attached to a
supply tube for fluid communication with an internal cavity of the balloon
and fill valve (FF 3-4). Haber teaches a balloon which is shaped and
dimensioned to circumscribe a body lumen (FF 6-7), where the balloon
includes a longitudinally extending body (FF 7).
Regarding claims 1 and 11, Haber teaches a supply tube 8 with a
distal and proximal end where the distal end is secured to an internal cavity
of the balloon and the proximal end is linked to a valve 14 which is shaped
and dimensioned to connect to tubing 8 and 12, tube connector 10 and the
balloon (FF 6-8).
Applying the KSR standard of obviousness to the findings of fact, we
conclude that the person of ordinary skill would have modified the balloon
system of Haber to incorporate the valve of Stevens as discussed by the
Examiner, since “providing the valve at a proximal end of a supply tube
extending from the balloon instead of having the valve included in the
balloon wall allows for a physician to more easily access the valve to
introduce or remove fluid from the balloon for later adjustment” (Ans. 6).
Such a combination is merely a “predictable use of prior art elements
according to their established functions.” KSR, 550 U.S. at 417.
Appellants contend that:
all Stephens discloses is an inflatable implant and provides
no disclosure that the inflatable implant is a gastric band as
required by the claims. “Gastric band” has a very specific
meaning in the art and Stephens makes absolutely no
reference to the disclosed inflatable implant being a gastric
band. Paragraphs [0110] to [0111] of Stephens make no
reference to use of the inflatable implant as a gastric band or
in a manner consistent with that of a gastric band.
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(App. Br. 12). Appellants contend that “Haber does not teach a “balloon-
type gastric band.” Haber teaches a gastrointestinal sphincter to be
surgically implanted around a lumen (e.g., bowel).” (App. Br. 18).
We are not persuaded. While we do not disagree with Appellants that
the term “gastric band” has a specific meaning in the art, Appellants’ claim
does not impose any specific limitations which distinguish the combination
of Stephens and Haber from the claimed balloons. Appellants do not
identify, and we do not find, any special definition in the Specification of
“gastric band” which would exclude the balloons of Stephens or Haber. To
the extent that “gastric band” is intended to impose a specific structural
limitation on the product, different from those listed in the body of the claim,
it is Appellants’ burden to incorporate that limitation into the claim or
Specification, so that the actual meaning of the claim can be discerned. See
In re Zletz, 893 F.2d 319, 322 (Fed. Cir. 1989) (“[D]uring patent prosecution
when claims can be amended, ambiguities should be recognized, scope and
breadth of language explored, and clarification imposed.”)
Appellants contend that “Haber does not teach positioning a valve at a
proximal end of a supply tube . . . Moving the fill valve and closure 507 or
fill valve 550 as suggested by the Examiner would destroy the device of
Stephens as there would be no structure for retaining fluid within the
inflatable implant” (App. Br. 20).
We are not persuaded. We agree with the Examiner that the
“limitation ‘a proximal end’ does not require that the valve is located
adjacent a terminal end of a supply tube” (Ans. 16). In addition, Appellants
fail to focus on the combination of Haber and Stephens, which clearly teach
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that wherever the fill valve is located, the balloon is capable of retaining
fluid in order to impose pressure on the lumen (FF 1, 6). In fact, Stephens
teaches the use of multiple fill valves, noting the use of “fill valves (inner
550, outer 552). A filler member (554) is also depicted that may be used to
independently fill the two bladders” (Stephens 9 ¶ 0112; FF 3). Also, as the
Examiner notes, “Figures 14A-14C clearly show the locking connector (506
receives 505) integrated on the same tubular section of the implant as the
valve (507)” (Ans. 17).
Claims 2, 5, and 21
The Examiner finds that Stephens “teaches that the valve (Stephens et
al., 550) is a check valve, and wherein the check valve is constructed to
prevent the flow of fluid from the proximal end of the supply tube” (Ans. 6).
Appellants contend that “[f]ill valve 550 permits the flow of fluid into
the inner bladder 542 and prevents the flow of fluid therefrom; the opposite
of that which is claimed” (App. Br. 21). Appellants contend that “the valve
provided by Stephens in view of Haber would function in directly the
opposite manner claimed. While the valves could be altered through
mechanical manipulation to allow for flow in the manner suggested by the
Examiner, the valves themselves are not achieving this flow, but rather the
manual manipulation of the valves is resulting in this flow” (Reply Br. 5).
We find that Appellants have the better position. These claims
require preventing flow to the balloon and permitting flow from the balloon,
which is in contrast to the flow of Stephens or Haber. While the Examiner is
undoubtedly correct that the valves of Stephens and Haber could be oriented
as required by claims 2, 5, and 21, the Examiner has not provided a reason to
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modify the valves of Stephens and Haber to do so. See KSR, 550 U.S. at 418
(There must be “a reason that would have prompted a person of ordinary
skill in the relevant field to combine the elements in the way the claimed
new invention does.”).
Claims 12 and 20
Appellants contend that “Stephens in view of Haber fails to disclose a
valve allowing flow in accordance with the requirements of the pending
claims” (App. Br. 25).
The Examiner finds that
to provide the valve of Stephens at the proximal end of a
supply tube extending between the balloon and valve for
delivering and removing fluid as taught by Haber, because
providing the valve at a proximal end of a supply tube
extending from the balloon instead of having the valve
included in the balloon wall allows for a physician to more
easily access the valve to introduce or remove fluid from the
balloon for later adjustment.

(Ans. 10).
We find that the Examiner has the better position. Unlike claim 2,
which requires the check valve permit “flow of fluid from the balloon . . .
toward to the proximal end of the supply tube,” claim 12 simply requires
that the check valve “prevent the flow of fluid from the fluid injection port . .
. to the distal end of the supply tube and permit the flow of fluid . . . toward
the fluid injection port” (claim 12). This flow of fluid is precisely that
contemplated by Stephens, who teaches “one or more optional one-way
valves form the passageway through the bladder wall permitting flow into
the interior bladder volume and preventing filler material flow out of the
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volume once either the bladder volume is filled or the introducer device is
removed from the one way valves” (Stephens 10-11 ¶ 0130; FF 5).
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that
Stephens and Haber render claims 1, 11, and 12 obvious.
The evidence of record does not support the Examiner’s conclusion
that Stephens and Haber render claims 2, 5, and 21 obvious.
SUMMARY
In summary, we affirm the rejection of claims 1, 11, 12, and 20 under
35 U.S.C. § 103(a) as obvious over Stephens and Haber. Pursuant to 37
C.F.R. § 41.37(c)(1)(vii), we also affirm the rejection of claims 13-15 and
17-19 as these claims were not argued separately.
We reverse the rejection of claims 2-10, 21 and 22 under 35 U.S.C. §
103(a) as obvious over Stephens and Haber.

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).

AFFIRMED-IN-PART

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