Ex Parte Viola

Board of Patent Appeals and Interferences

Aug 8, 2012

11820878 (B.P.A.I. Aug. 8, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte FRANK J. VIOLA
__________

Appeal 2011-003607
Application 11/820,878
Technology Center 3700
__________

Before ERIC GRIMES, FRANCISCO C. PRATS, and
JACQUELINE WRIGHT BONILLA, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to a gastric
restrictor device. The Examiner rejected the claims as obvious.
We have jurisdiction under 35 U.S.C. § 6(b). We reverse the
Examiner’s obviousness rejection, but enter a new anticipation rejection
under 37 C.F.R. § 41.50(b).

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STATEMENT OF THE CASE
Claims 1-9 stand rejected and appealed (App. Br. 3). Claim 1, the
only independent claim, is representative and reads as follows:
1. A gastric restrictor assembly comprising:
a housing including a base portion, a waist portion and head
portion, the housing defining a throughbore;
a pin holder including a plurality of pins extending therefrom,
the pin holder configured for being lockingly received within the
housing, wherein the plurality of pins are supported by the pin holder
to extend across the waist portion when the pin holder is received
within the housing.
The sole ground of rejection before us for review is the Examiner’s
rejection of claims 1-9 under 35 U.S.C. § 103(a) as obvious over Regula
1

and Gannoe
2
(Ans. 4).
OBVIOUSNESS
The Examiner cited Regula as disclosing a device substantially as
recited in claim 1, but conceded that Regula’s device “lacks a waist portion
as claimed” (Ans. 5). To address that deficiency, the Examiner cited
Gannoe as disclosing a similar device having a waist portion that “collects
and fixes gathered tissues within a space for tissue acquired by suction”
(id.).
Based on the references’ teachings, the Examiner concluded that an
ordinary artisan would have considered it obvious “to modify the invention
of Regula . . . with the waist portion as taught by Gannoe in order to both
gather and fix tissues within a fixing cavity” (id. at 6). The Examiner
reasoned that an artisan would have been “motivated to modify Regula with

1
U.S. Patent No. 5,346,501 (issued Sept. 13, 1994).
2 U.S. Pat. App. Pub. No. 2004/0092974 A1 (published May 13, 2004).
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the waist portion as taught by Gannoe to secure tissues within a suction
space since Regula also sucks tissue into place before securing it” (id. at 5).
Appellant argues, among other things, that an ordinary artisan would
not have been prompted to modify Regula’s device in the manner posited by
the Examiner “because the anastomotic device of Regula already includes a
mechanism for gathering and fixing tissue using suction” (App. Br. 9).
Moreover, Appellant argues, because the devices in the two references
operate in substantially distinct ways, it is unclear how Gannoe’s device
would be combined with Regula’s (see id.).
In KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 415 (2007), while the
Supreme Court emphasized “an expansive and flexible approach” to the
obviousness question, it also reaffirmed the importance of determining
“whether there was an apparent reason to combine the known elements in
the fashion claimed by the patent at issue.” Id. at 418 (emphasis added).
Thus, “[o]bviousness requires more than a mere showing that the prior
art includes separate references covering each separate limitation in a claim
under examination.” Unigene Laboratories, Inc. v. Apotex, Inc., 655 F.3d
1352, 1360 (Fed. Cir. 2011).
Instead, “[i]n determining whether obviousness is established by
combining the teachings of the prior art, the test is what the combined
teachings of the references would have suggested to those of ordinary skill
in the art.” In re GPAC Inc., 57 F.3d 1573, 1581 (Fed. Cir. 1995) (internal
quotations omitted).
We agree with Appellant that the Examiner has not adequately
explained why the cited references would have suggested the device recited
in claim 1 to an ordinary artisan.
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As Appellant explains, Regula discloses “a circular anastomotic
device which provides an aligned inverted junction between distal and
proximal halves of tubular organs, especially the small and large bowel,
without the need for purse string suturing” (Regula, col. 2, ll. 36-40). The
device consists of two separate assemblies, termed “introducer portions,”
which are placed at the two free ends of the tubular organ to be joined, the
joining of the ends of the organ being accomplished by snap fitting the two
assemblies together (see id. at col. 8, ll. 18-53; see also Figures 9 and 10).
To hold the tissue at the ends of the tubular organ together, the tissue
edges must be placed on a series of pins located at the circumference of the
introducer portions (see id. at Figure 9). As the Examiner found, Regula
discloses that, after the introducer portions are placed in the bowel, “suction
is applied so that the pins 29 of the ring 25 are caused to hold tissue thereon”
(id. at col. 7, ll. 55-56).
Gannoe discloses a device “for dividing a hollow body organ or
otherwise restricting or partitioning a certain section of that organ, such as a
stomach, intestine or gastrointestinal tract” (Gannoe [0002]). Gannoe’s
device has two components, an inner portion 109 and an outer portion 108
that move in relation to each other to allow formation of a tissue ring in the
stomach (see id. at [0049]). As the Examiner found, Gannoe uses suction to
pull tissue between the distal elements of the inner and outer portions of the
device, the tissue ring being created by stapling the gathered tissue together
(see id. at [0050]-[0051]; see also Figures 5B and 5C).
The Examiner identified element 109 of Gannoe’s device as
corresponding to the waist portion of the device recited in claim 1 (see Ans.
5). The ultimate function of the inner portion 109 of Gannoe’s device is to
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move the distal portion 110 of the device in relation to the inner portion,
thereby allowing the surgeon to clamp tissue between the two portions of the
device so that fastening elements may be inserted into the tissue (Gannoe
[0051]; see also Fig. 5C).
However, in contrast to using separate fastening elements that would
use the clamping functionality supplied by Gannoe’s element 109, Regula’s
device itself acts as the clamping mechanism, acting in concert with the
tissue-engaging pins at the device’s circumference (see, e.g., Regula, col. 8,
ll. 18-53; see also Figures 9 and 10). Thus, as Regula’s device has no need
of the separate clamping functionality that would be provided by the element
characterized by the Examiner as corresponding to the waist portion of claim
1, we agree with Appellant that an ordinary artisan would not have been
prompted to include Gannoe’s waist element on Regula’s device. We also
agree with Appellant that the Examiner has not explained with adequate
specificity how an ordinary artisan would have configured individual parts
of the resulting device so as to maintain the functionality required by
Regula.
The Examiner argues that an ordinary artisan would have had
“motivation to modify Regula in view of Gannoe since the waist portion of
Gannoe enhances the function of Regula” (Ans. 9). The Examiner does not,
however, point to any teaching in either reference supporting the premise
that a waist portion would improve Regula’s device, nor has the Examiner
clearly explained why an ordinary artisan would have recognized that to be
the case. Moreover, the Examiner suggests to no other reason as to why an
artisan might have modified Regula’s device in view of Gannoe.
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Thus, as we are not persuaded that the Examiner has made out a prima
facie case of obviousness as to claim 1, we reverse the Examiner’s rejection
of that claim, and its dependents, over Regula and Gannoe.
NEW GROUND OF REJECTION – ANTICIPATION
Under the provisions of 37 C.F.R § 41.50(b), we enter the following
new ground of rejection:
Claim 1 is rejected under 35 U.S.C. § 102(b) as anticipated by Regula.
Claim 1 recites a gastric restrictor assembly that has two components,
a housing and a pin holder. The housing has a base portion, a waist portion
and head portion. The housing must define a throughbore.
Claim 1 requires the pin holder to have a plurality of pins extending
from it. The pin holder is configured to be lockingly received within the
housing, the plurality of pins being supported by the pin holder and
extending across the waist portion when the pin holder is received within the
housing.
As noted above, Regula discloses “a circular anastomotic device
which provides an aligned inverted junction between distal and proximal
halves of tubular organs, especially the small and large bowel, without the
need for purse string suturing” (Regula, col. 2, ll. 36-40). Figure 10 of
Regula is reproduced below:

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Figure 10 shows Regula’s device in assembled form, joining together
two free ends of a tubular organ.
The term “housing” in claim 1 encompasses Regula’s overall
assembled device. As required by claim 1, the housing of Regula’s device
includes an assembly, which includes an element 20, that corresponds to the
claimed base portion. The housing of Regula’s device has a second
assembly, which includes element 30, that corresponds to the head portion
recited in claim 1. As to the waist portion required by claim 1, Figure 10
shows an intermediate section, not denoted with any reference number,
across which a set of pins passes.
Figure 2 of Regula is reproduced below:

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Figure 2 shows Regula’s device in disassembled form. As seen in
Figure 2, the device includes a “generally cylindrical interior portion 44”
that defines a throughbore that extends the entire length of the device’s
housing (Regula, col. 6, l. 23). The middle portion of the central cylinder of
the device, located between the two assemblies shown in Figure 10,
corresponds to the waist portion of the device of claim 1.
As required by claim 1, Regula’s device includes a pin holder 22, with
pins 24, which are lockingly received within the housing when the device is
fully assembled:
As seen in FIG. 2, each of the legs 24 has flanges 27,
such that a number of useful gap setting distances are provided.
The user is able to choose over a relatively infinite range, the
appropriate spacing between the two rings plates 20,30 with
flanges 25 [sic, 27] locked on detents 37 contained in each hole
34.

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(Id. at col. 6, ll. 8-13.) As also seen in Figure 2, and required by claim 1, the
pins extend across the central waist portion of the device when the device is
fully assembled.
Accordingly, we find that Regula discloses a device having all of the
features required by claim 1. While we have only included claim 1 in this
rejection, should prosecution resume in this case the Examiner should
consider whether any of its dependent claims should be subject to a rejection
based on our analysis here.
SUMMARY
We reverse the Examiner’s obviousness rejection of claims 1-9 over
Regula and Gannoe.
However, we enter a new ground of rejection of claim 1 under 35
U.S.C. § 102(b) as being anticipated by Regula.
TIME PERIOD FOR RESPONSE
This decision contains a new ground of rejection pursuant to 37
C.F.R. § 41.50(b) (effective September 13, 2004, 69 Fed. Reg. 49960
(August 12, 2004), 1286 Off. Gaz. Pat. Office 21 (September 7, 2004)). 37
C.F.R. § 41.50(b) provides “[a] new ground of rejection pursuant to this
paragraph shall not be considered final for judicial review.
37 C.F.R. § 41.50(b) also provides that the appellant, WITHIN TWO
MONTHS FROM THE DATE OF THE DECISION, must exercise one of
the following two options with respect to the new ground of rejection to
avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new evidence relating
to the claims so rejected, or both, and have the matter
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reconsidered by the examiner, in which event the proceeding
will be remanded to the examiner . . . .

(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same record . . . .

REVERSED, 37 C.F.R. § 41.50(b)

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