Ex Parte Shelton et al

Patent Trial and Appeal Board

Mar 5, 2013

11652164 (P.T.A.B. Mar. 5, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte FREDERICK E. SHELTON IV, JEROME R. MORGAN,
STEPHEN J. BALEK, and DOUGLAS K. SIEBENALER
____________

Appeal 2011-000333
Application 11/652,164
Technology Center 3700
____________

Before GAY ANN SPAHN, MICHAEL C. ASTORINO, and
WILLIAM A. CAPP, Administrative Patent Judges.

SPAHN, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Frederick E. Shelton IV et al. (Appellants) seek our review under 35
U.S.C. § 134 of the Examiner’s rejection of claims 1-21. We have
jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

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Claimed Subject Matter
The claimed subject matter relates to “surgical staplers, and, more
particularly, to surgical staplers having a curved end-effector and to surgical
techniques for using same.” Spec. 2, para. [0001]. Claim11, 17, and 21 are
independent and claim 1, reproduced below, is illustrative of the subject
matter on appeal.
1. A surgical stapler, comprising:
a staple cartridge configured to removably store at least a
first staple and a second staple;
an anvil configured to deform said first staple and said
second staple, wherein said first staple is movable between a
first position and a second position, wherein said first position
and said second position define a first axis, wherein said second
staple is movable between a first position and a second position,
wherein said first position and said second position of said
second staple define a second axis, and wherein said first
axis and said second axis define an angle therebetween;
a cutting member having a cutting edge;
a staple driver configured to move said first staple along
said first axis and said second staple along said second axis; and
a flexible drive bar configured to move said staple driver
and said cutting member along a curved path between said first
axis and said second axis.

Rejections
The following Examiner’s rejections are before us for review:
I. claims 1-10, 15, 16, 19, and 21 are rejected under 35 U.S.C.
§ 112, second paragraph, as indefinite for failing to particularly point out
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and distinctly claim the subject matter which Appellants regard as the
invention;1 and
II. claims 1, 2, and 4-21 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Yoon (US 5,655,698, issued Aug. 12, 1997) and Noiles
(US 4,576,167, issued Mar. 18, 1986).

OPINION
Rejection I – Indefiniteness
Claims 1-10, 15,16, 19, and 21
All of claims 1-10, 15, 16, 19, and 21 have similar language as to first
and second staples each being moveable between first and second positions
to define first and second axes, respectively.
The Examiner determines that the above-mentioned language in each
of claims 1-10, 15, 16, 19, and 21 is “indefinite in that said first position,
second position, first axis, and second axis have no point of reference,” as
“[t]hese limitations do[] not clearly describe any structure capable of
defin[ing] the relation[ship] between the movement of the staples with the
other component[s] of the surgical stapler, and thereby, the point of
reference for the claimed axes is indefinite.” Ans. 3-4.
Appellants argue, and we agree, that “the claims are clear on their
face” in reciting first and second staples removably stored within the staple

1 Although the Examiner’s ground of rejection lists all of claims 1-21 as
being rejected under 35 U.S.C. § 112, second paragraph, the Examiner has
withdrawn the rejection as to claims 11 and 17. Ans. 3. Furthermore, since
claims 12-14, 18, and 20, which depend either directly or indirectly from
claim 11 or claim 17, lack a basis for rejection under 35 U.S.C. § 112,
second paragraph, as a matter of course, the rejection of these claims is
withdrawn as well.
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cartridge and being movable along different axes between two positions to
define a frame of reference. App. Br. 15-16. As stated by Appellants, “the
[S]pecification describes the deployment of staples from a staple cartridge
by a staple driver, such as the exemplary embodiment depicted in Figs. 6 and
7” which show “the progression of staples 132 between first and second
positions along axes by driver 130” so that the disputed claim language “is
abundantly clear and certainly definite.” App. Br. 16-17.
Accordingly, with respect to the disputed first and second positions
and first and second axes limitation, we do not sustain the Examiner’s
rejection of claims 1-10, 15, 16, 19, and 21 under 35 U.S.C. § 112, second
paragraph, as indefinite.
Additional indefiniteness issues with respect to claim 21
Claim 21 additionally recites “the pulmonary artery” and that the first
and second axes “converge on a side of the pulmonary artery opposite the
thoracic cavity sidewall.” App. Br., Clms. App’x. The Examiner
determines both of the above-quoted recitations of claim 21 to be indefinite.
Ans. 4.
As for the first quoted language supra, the Examiner determines that
“the pulmonary artery” lacks antecedent basis. Id. Appellants argue, and we
agree, that
the pulmonary artery referred to in Claim 21 is in the context of
“a sidewall of the thoracic cavity of a patient” which a person
of ordinary skill in the art would fully and completely
understand that “the” pulmonary artery referred to in the claim
was that of the recited patient and, thus, such a recitation is
definite.
App. Br. 19.
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Accordingly, with respect to the first quoted claim language supra, we
do not sustain the Examiner’s rejection of claim 21 under 35 U.S.C. § 112,
second paragraph, as being indefinite.
As for the second quoted language supra, the Examiner determines
that “it is unclear what ‘converge on a side of the pulmonary artery opposite
the thoracic cavity sidewall’ encompasses” since “[t]he claim is relying on
body parts which are not part of the structural inventive concept of the
instant application.” Ans. 4. From the Examiner’s statements, there does
not appear to be any basis for the rejection of the second quoted language
supra as being indefinite. See also App. Br. 19. First, the Examiner
understands that the “body parts,” i.e., “the pulmonary artery” and “the
thoracic cavity,” are not part of the structure of the apparatus. We agree.
Indeed, one having ordinary skill in the art would understand the inclusion
of the “body parts” into the claim as merely reference points to help identify
the structure of the surgical stapler’s staple channel and anvil. Therefore,
the recited claim language concerning the convergence of the first and
second axes “on a side of the pulmonary artery opposite the thoracic cavity
sidewall” is merely an expression of the structure of the surgical stapler’s
staple channel and anvil, and is not indefinite.
Accordingly, with respect to the second quoted language supra, we
do not sustain the Examiner’s rejection of claim 21 under 35 U.S.C. § 112,
second paragraph, as indefinite.
Rejection II – Obviousness based on Yoon and Noiles
Claims 1, 2, 4-10, 15, 19, and 21
In addition to the above-discussed claim language of first and second
staples movable between first and second positions along first and second
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axes, respectively, independent claims 1 and 21, and dependent claims 2, 4-
10, 15, and 19 include the limitation that “said first axis and said second axis
define an angle therebetween.” App. Br., Clms. App’x.
The Examiner finds that Yoon discloses a surgical stapler including,
inter alia, an anvil 322 configured to deform staples 42, wherein:
the first staple is movable between a first position (within staple
slot 320, 322 before being deployed and deformed against the
anvil) and a second position (after being deployed and
deformed against the anvil), wherein said first position and said
second position of the first staple define a first axis (i.e.[,] a
longitudinal axis along the proximal end of 318 wherein said
first staple is deployed and deformed; fig. 28) and said second
staple is movable between a first position (within the staple
slots) and a second position (after being driven and deformed
against the anvil), wherein said first position and second
position of said second staple define a second axis (i.e.[,] a
longitudinal axis along the distal end of 318 wherein said
second staple is deployed and deformed; fig. 28), wherein said
first axis and said second axis define an angle therebetween
(fig. 28).
Ans. 4-5.
Appellants argue, and we agree, that Yoon’s “staple slots 320 of jaw
314 are parallel to one another and do not define axes which define an angle
therebetween,” because “[t]he staple slots 320, although positioned along a
curved path, are not oriented so as to deploy staples along axes which are at
[an] angle with one another.” App. Br. 23; see also App. Br. 24-25. Yoon’s
Figure 28, pointed to the by the Examiner for the interpretation that Yoon
discloses first and second axes at an angle with respect to one another,
depicts a jaw 314 of a surgical stapler having staple slots 320 which
movably house staples 42. Yoon, col. 10, l. 52 to col. 11, l. 4 and Fig. 28.
Each of the staples 42 are capable of moving along an axis that is parallel
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with the axis of the staple slot and perpendicular to the plane of the upper
surface of the staple cartridge 318. Thus, Appellant correctly states that
Yoon’s staple slots 320 do not define axes which have an angle
therebetween. The Examiner’s interpretation that a longitudinal axis along
the proximal end of staple cartridge 318 wherein the first staple is deployed
and deformed in Figure 28 constitutes a first axis, a longitudinal axis along
the distal end of staple cartridge 318 wherein the second staple is deployed
and deformed in Figure 28 constitutes a second axis, and the first and second
axis define an angle therebetween does not satisfy the claim language as the
longitudinal axes pointed to by the Examiner are not the axes along which
the staples move from a first position to a second position.
Accordingly, we do not sustain the Examiner’s rejection of claims 1,
2, 4-10, 15, 19, and 21 under 35 U.S.C. § 103(a) as unpatentable over Yoon
and Noiles.
Independent claims 11 and 17 and dependent claims 12-16 and 18-20
Each of independent claims 11 and 17 are directed to a surgical stapler
and recite that either a flexible driver or a flexible drive bar, respectively, is
“operably engaged with said cutting member to move said cutting member
relative to said anvil and the staple cartridge.” App. Br., Clms. App’x.
The Examiner finds that Yoon discloses either “a driver (fig. 25)” or
“a drive bar (242) configured to move said staple driver [(234)] and said
cutting member [(244 or 326)] along a curved path of the stapler (as shown
in the embodiment of fig. 28).” Ans. 5-6; see also Ans. 7. The Examiner
also finds Yoon fails to disclose that “said drive bar is flexible and has an
elongate cross-section defined by a width and a height, wherein said width is
greater than said height” and “wherein said width defines an axis that is not
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parallel to said cutting edge axis.” Ans. 5-6. To cure the deficiencies of
Yoon, the Examiner turns to Noiles to teach
the concept of a surgical stapler comprising a flexible drive bar
(80) having an elongate cross-section defined by a width and a
height (fig. 9) for the purposes of enhancing flexibility of the
drive bar during a tissue fastening procedure without
significantly affecting its tensile strength necessary to drive the
staples and cut the tissue.”
Ans. 5-7 (citing Noiles, col. 7, l. 56 to col. 8, l. 11). The Examiner
concludes that it would have been obvious to one of ordinary skill in the art
to modify Yoon’s drive bar to be flexible and have “a width greater than a
height as taught by Noiles” in order to yield the predictable results of “a
flexible driver having a width greater than its height, wherein the width
defines an axis which is not parallel to the cutting edge of the cutting
member, enhancing flexibility of the driver along the cutting edge axis” and
“without significantly affecting its tensile strength during a fastening
procedure.” Ans. 6-8.
Appellants argue that Noiles drive bar 80 “is not, in fact, a drive bar
which moves a cutting member as recited in Claim 11; rather, Noiles . . .
refers to component 80 as a ‘flexible band’ which is pulled in order to
position anvil 20 relative to staple holding assembly 40.” App. Br. 26 and
28 (citing Noiles col. 7, l. 56 to col. 8, l. 68). More particularly, Appellants
argue that “[c]ontrary to the Examiner’s position, the knife 52 of Noiles . . .
is moved by the actuation of handles 120a and 120b which advance tube 70
and knife pusher assembly 44.” Id. (citing Noiles, col. 10, ll. 28-42).
We are persuaded by Appellants’ arguments. Noiles flexible band 80
is mounted in tube 70 for longitudinal reciprocal motion relative to the
surrounding elements and is made up of several thin strips of metal 80a, 80b,
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and 80c. Noiles, col. 7, ll. 56-62. The proximal end of flexible band 80 is
connected to the distal end of rod 160 by pins 168 and the distal end of band
80 is connected to the proximal end of rod 30 by pins 82. Noiles, col. 7, ll.
62-66. The principal function of flexible band 80 is to act as a tension
member for transmitting longitudinal tension force (and accompanying
motion) from actuator assembly 14 to stapling assembly 12 for drawing
anvil assembly 20 toward staple holding assembly 40 and then holding these
two assemblies together to clamp tissue during stapling and cutting. Noiles,
col. 8, ll. 24-30. However, it is pusher assembly 44, mounted for
longitudinal motion relative to housing 42, that is for driving staples 50 and
knife 52 toward anvil assembly 20, and staples 50 and knife 52 are driven by
squeezing handles 120a and 120b together. Noiles, col. 4, ll. 25-27, and col.
5, ll. 28-29. Thus, one of ordinary skill in the art would not consider
Noiles’s flexible band 80 to constitute the claimed flexible driver or drive
bar operatively engaged with the cutting member to move the cutting
member relative to the anvil and the staple cartridge.
Accordingly, we do not sustain the Examiner’s rejection of
independent claims 11 and 17, and claims 12-16 and 18-20 depending
therefrom, under 35 U.S.C. § 103(a) as unpatentable over Yoon and Noiles.

DECISION
We reverse the Examiner’s decision to reject claims 1-21.

REVERSED