Ex Parte Hess et al

Board of Patent Appeals and Interferences

Jan 6, 2012

11541098 (B.P.A.I. Jan. 6, 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.
11/541,098 09/29/2006 Christopher J. Hess END5970USNP/060499 9834
92223 7590 01/06/2012
K&L Gates LLP
210 SIXTH AVENUE
PITTSBURGH, PA 15222-2613
EXAMINER
WEEKS, GLORIA R
ART UNIT PAPER NUMBER
3721
MAIL DATE DELIVERY MODE
01/06/2012 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte CHRISTOPHER J. HESS, WILLIAM B. WEISENBURGH II,
JEROME R. MORGAN, FREDERICK E. SHELTON IV,
LESLIE M. FUGIKAWA, and EUGENE L. TIMPERMAN
____________

Appeal 2010-003193
Application 11/541,098
Technology Center 3700
____________

Before PHILLIP J. KAUFFMAN, WILLIAM V. SAINDON, and
JAMES P. CALVE, Administrative Patent Judges.

CALVE, Administrative Patent Judge.

DECISION ON APPEAL

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Application 11/541,098

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STATEMENT OF THE CASE
Appellants appeal under 35 U.S.C. § 134 from the Examiner’s
rejection of claims 1, 3-6, and 8-39. Claims 2 and 7 have been cancelled.
We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM-IN-PART.
THE INVENTION
The claims relate to a surgical stapling system. Claims 16 and 26 are
illustrative of the claimed subject matter on appeal:
16. A surgical stapling system, comprising:
a stapler, said stapler including:
an anvil, said anvil including a forming surface; and
a staple cartridge, said staple cartridge configured for
removably storing a first staple and a second staple therein,
wherein said first staple includes a deformable portion
comprised of a permanently deformable material which is
configured to be permanently deformed to capture tissue
within said first staple, and wherein said second staple
includes a deformable portion comprised of a permanently
deformable material which is configured to be permanently
deformed to capture tissue within said second staple, said
first staple being connected to said second staple by a bridge
conterminous with said first staple and said second staple,
said staple cartridge including a top surface and a bottom
surface, said top surface disposed opposite said forming
surface, said bottom surface having at least one recess
therein for receiving said first staple, said second staple, and
said bridge, and wherein said recess comprises a first portion
configured to receive said first staple, a second portion
configured to receive said second staple, and an intermediate
portion positioned intermediate said first portion and said
second portion configured to receive said bridge connecting
said first staple and said second staple through said bottom
surface, and wherein said anvil forming surface is
configured to permanently deform said deformable portion
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of said first staple and said deformable portion of said
second staple.
26. A surgical stapling system, comprising:
a first staple including a first deformable portion comprised of a
permanently deformable material which is configured to be
permanently deformed to capture tissue within said first staple;
a second staple including a second deformable portion
comprised of a permanently deformable material which is
configured to be permanently deformed to capture tissue within
said second staple; and
a bridge connecting said first staple to said second staple,
wherein said bridge is conterminously connected with said first
staple and said second staple, and wherein at least a portion of said
bridge is flexible such that said first staple is not detached from
said second staple when said first staple is deployed.

REJECTIONS
The Examiner relies on the following as evidence of unpatentability:
Green ‘4451 US 4,402,445 Sep. 6, 1983
Green ‘250 US 4,610,250 Sep. 9, 1986
Korthoff US 4,667,674 May 26, 1987
Hermes US 5,282,829 Feb. 1, 1994
DeFonzo US 5,497,933 Mar. 12, 1996
Green ‘373 US 5,653,373 Aug. 5, 1997

The following grounds of rejection are before us for review:
1. The Examiner rejected claims 1, 3-6, 8-20, 24, 25, and 29-36
under 35 U.S.C. § 103(a) as being unpatentable over Korthoff, Green ‘373,
and Hermes.

1 The Answer occasionally refers to Green ‘445 as US 4,402,405. See, e.g.,
Ans. 5. We understand, and Appellants acknowledge, this citation to be a
typographical error and intended as a reference to Green ‘445. App. Br. 17.
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Application 11/541,098

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2. The Examiner rejected claims 21, 22, 26-28, and 37-39 under
35 U.S.C. § 103(a) as being unpatentable over Green ‘250 and Green ‘445.
3. The Examiner rejected claim 23 under 35 U.S.C. § 103(a) as
being unpatentable over Korthoff in view of Green ‘373 and Hermes, as
applied to claim 11, and further in view of DeFonzo.
ANALYSIS
Claims 1, 3-6, 8-20, 24, 25, and 29-36 based on Korthoff, Green ‘373, and
Hermes
Claims 1, 3-5, 24, 25, and 29-32
Independent claim 1 recites a surgical stapling system with first and
second staples, each having deformable members extending from a base and
a crown with a tissue-contacting surface, wherein the deformable members
are configured to be permanently deformed to capture tissue intermediate the
deformable member and the tissue-contacting surface of the crown.
The Examiner found that Korthoff discloses a surgical stapling system
including staples 400 with deformable members 102 extending from a base
401, and a crown 402 having a tissue-contacting surface (Figure 5), wherein
the deformable members 102 are configured to be permanently deformed to
capture tissue intermediate each deformable member 102 and the first tissue-
contacting surface of the crown 402 as called for in claim 1. Ans. 3. The
Examiner also found that Korthoff’s deformable members 102 are capable
of permanently deforming such that the driving of the staples determines
their configuration when deployed from a stapler. Ans. 7-8. The Examiner
also found that Green ‘250 discloses staples with deformable portions that
are permanently deformed after being deployed from a stapler. Ans. 3-4, 7.
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We agree with Appellants that Korthoff does not disclose staples with
deformable members comprised of permanently deformable material that is
configured to be permanently deformed to capture tissue intermediate the
deformable member and a tissue-contacting surface of a crown of the staple.
See Br. 18-20. Korthoff’s two-part fastener 400 retains tissue between base
402 and a retainer 104. Prongs 102 extending from the base 402 are driven
through tissue to engage apertures 103 in retainer 104. Korthoff, col. 3, ll.
34-37; col. 3, l. 66 – col. 4, l. 3; fig. 5. The Examiner’s findings that prongs
102 comprise permanently deformable material that is capable of
maintaining a deformed configuration after deploying (Ans. 3, 7-8) is not
supported by evidence of record. Prongs 102 comprise a resinous material
that is too resilient to hold deformed shapes. Korthoff, col. 1, ll. 28-38; col.
3, ll. 37-39; Br. 20. Thus, retainers 104 are required to hold resilient prongs
102 in position. Korthoff, fig. 5. Figures 6 and 7 of Korthoff cited by the
Examiner (Ans. 7-8) show the resilient base 402 deforming and prongs 102
bending inward or outward, rather than maintaining a permanently deformed
position. Korthoff, col. 5, ll. 1-3; figs. 6, 7.
We also agree that Green ‘373’s two-part fasteners do not comprise a
permanently deformable material that is configured to permanently deform.
Br. 21. Green ‘373’s two-part fasteners have legs that are held in apertures
of a retainer, unlike staples that have deformable legs. Green ‘373, col. 3, ll.
52-55; Abstract. The legs of the two-part fasteners do not permanently
deform to capture tissue. See Greene ‘373, col. 10, ll. 18-31; fig. 17; Br. 21.
The Examiner’s citation of Green ‘250 is not persuasive because the
Examiner did not rely on Green ‘250 to reject claim 1. Moreover, as
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discussed infra, Green ‘250 does not disclose members comprising a
permanently deformable material configured to permanently deform.
As such we cannot sustain the Examiner’s rejection of claim 1 or
claims 3-5, 24, 25, and 29-32, which depend therefrom.
Claims 6, 8-10, and 33-36
Independent claim 6 recites a surgical stapling system with a first and
second staple, each with a deformable member comprised of a permanently
deformable material configured to be permanently deformable to capture
tissue intermediate the deformable member and a tissue-contacting surface
of the staple crown. The Examiner rejected claim 6 on the same grounds as
claim 1. Ans. 3-4, 7-8. Appellants argue that Korthoff, Green ‘373, and
Hermes do not establish a prima facie case of obviousness as to claim 6 for
the same reasons as Appellants set forth for claim 1. Br. 24-25. We agree
for the reasons expressed above.
As such, we cannot sustain the Examiner’s rejection of claim 6 or
claims 8-10 and 33-36, which depend therefrom.
Claims 11-15
Independent claim 11 recites a surgical stapling system with a stapler
having an anvil with a forming surface that is configured to permanently
deform the deformable portion of a first and second staple. The Examiner
found that Korthoff (via incorporation of Green ‘445) discloses a surgical
stapling system with an anvil forming surface that pushes retainers towards a
staple. Ans. 5 (citing Korthoff, col. 1, ll. 45-49). The Examiner also found
that Green ‘373 discloses a stapler and anvil forming surface 124. Ans. 5
(citing col. 2, ll. 47-50; fig. 23). The Examiner further found Green ‘373’s
retainers 52, 54 and the surface supporting the retainers 52, 54 are anvil
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forming surfaces. Ans. 9 (citing Green ‘373, fig. 16). The Examiner found
that anvils have a surface opposite to a staple cartridge and the anvils in each
reference are capable of permanently deforming a staple released from a
staple cartridge. Ans. 9-10. The Examiner cited Green ‘250 as an example
of an anvil forming surface 12 that deforms deformable staples. Ans. 10.
We agree with Appellants that the combination of Korthoff, Green
‘373, and Hermes does not disclose an anvil with an anvil forming surface as
called for in claim 11. The retainer support 30 of Green ‘445 is not an anvil
forming surface configured to permanently deform a deformable portion of a
staple as called for in claim 11.2 App. Br. 27. The retainer support 30 is a
cartridge that holds retainers 80 of a two-part fastener. Green ‘445, col. 4, ll.
12-16. When fasteners 100 are driven into interlocking engagement with the
retainers 80, the retainers 80 pull out of support 30 and remain interlocked
with fasteners 100. Green ‘445, col. 4, ll. 23-43; figs. 2-5; Br. 27. The
Examiner has not adequately explained how support 30, which is designed
to hold retainers 80 of a two-part fastener, provides an anvil forming surface
that is capable of permanently deforming deformable portions of staples.
See Green ‘445, figs. 4, 5; Br. 27.
We agree with the Examiner that Green ‘373 discloses an anvil with
forming surfaces 124 configured to permanently deform deformable portions
of staples. Ans. 5. Green ‘373 discloses that the leg deforming anvils 124
are used to effect closure of metal staple fasteners by engaging the staple
legs with the anvils 124 (col. 12, ll. 50-57), whereas retainer holders 56, 58
secure retainers 52, 54 in alignment with fasteners 22, 26 to effect closure of

2 The Office Action mailed Nov. 26, 2008 at 4 cites element 30 in Green
‘445 as corresponding to the claimed anvil and forming surface.
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two-part fasteners (col. 10, ll. 11-34; figs. 16, 17). The Examiner has not
explained why a person of ordinary skill in the art would use leg deforming
anvils 124, which are designed to permanently deform the legs of metal
staples, for two-part resilient fasteners. Green ‘373, col. 2, ll. 48-50; Br. 28.
In light of this disclosure, the Examiner’s finding that retainers 52, 54 and
retainer holders 56, 58 provide anvil forming surfaces for permanently
deforming staples released from a cartridge (Ans. 9) is not supported by the
evidence of record.3
Accordingly, we cannot sustain the Examiner’s rejection of claim 11
or claims 12-15, which depend therefrom.
Claims 16-20
Independent claim 16 recites a surgical stapling system with a stapler
having an anvil with a forming surface configured to permanently deform
the deformable portion of a first and second staple. The Examiner rejected
claim 16 on the same grounds as claim 11. Ans. 5, 9-10. Appellants argue
that Korthoff, Green ‘373, and Hermes do not establish a prima facie case of
obviousness as to claim 16 for the reasons set forth for claim 11. Br. 29-30.
We agree for the reasons set forth above. Accordingly, we cannot sustain
the rejection of claim 16 or claims 17-20, which depend therefrom.
Claims 21, 22, 26-28, and 37-39 based on Green ‘250 and Green ‘445
Claims 26-28 and 37-39
Independent claim 26 recites a surgical stapling system with first and
second staples, each comprising a permanently deformable material that is
configured to be permanently deformed to capture tissue within each staple.

3 The Examiner’s citation of Green ‘250 is not persuasive because the
Examiner did not rely on Green ‘250 to reject claim 11.

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The Examiner found that Green ‘250 discloses a first staple (part of fastener
11 with prongs 14, 15) and a second staple (part of fastener 11 with prongs
16, 17), each having permanently deformable members 14, 15, 16, 17 that
are capable of capturing tissue within each staple. Ans. 6, 13 (citing fig. 5).
We agree with Appellants that the prongs 14-17 of Green ‘250 do not
comprise permanently deformable material that is configured to permanently
deform and capture tissue within each staple. Unlike metal fasteners, prongs
14-17 are made of a resinous material that is too resilient to hold a deformed
shape. Green ‘250, col. 1, ll. 24-34; col. 2, ll. 51-53; see Br. 36-37.
Accordingly, we cannot sustain the Examiner’s rejection of claim 26
or claims 27, 28, and 37-39 which depend therefrom.
Claims 21 and 22
Independent claim 21 recites a surgical stapling system with a stapler
that includes an anvil forming surface and a staple cartridge configured for
removably storing first and second staples each comprising a permanently
deformable material. The Examiner found that Green ‘250 discloses an
anvil and anvil forming surface via its incorporation of Green ‘445, which
discloses a stapler with an anvil 30 with a forming surface. Ans. 6. The
Examiner also found Green ‘250 discloses an anvil 12 and a staple cartridge
configured for removably storing first and second staples with permanently
deformable members 14, 15, 16, 17 configured to capture tissue as called for
in claim 21. See Ans. 6, 13 (citing Fig. 5 of Green ‘250).
Appellants argue claims 21 and 22 as a group. Br. 37-39. We select
claim 21 as a representative claim of the group. Claim 22 stands or falls
with claim 21. Appellants recite limitations of claim 21 (Br. 37) and argue
that Green ‘250 and Green ‘445 do not disclose a staple as recited in claim
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26 or an anvil forming surface (Br. 38) but do not explain why any of the
Examiner’s articulated findings (see, e.g. Ans. 6, 13) are in error. For
example, the Examiner found that Green ‘250 discloses an anvil and a
cartridge that is capable of storing first and second staples comprising a
permanently deformable material and bridge. Ans. 6, 13. Appellants have
not shown error in these findings. See In re Jung, 637 F.3d 1356, 1365 (Fed.
Cir. 2011) (noting with approval the Board’s practice of requiring appellants
to identify alleged error in an examiner’s rejection and then reviewing the
rejection “based upon the issues identified by appellant, and in light of the
arguments and evidence produced thereon.”); see also In re Schreiber, 128
F.3d 1473, 1478 (Fed. Cir. 1997) (where the examiner finds that prior art
structure is capable of performing a claimed function, the burden shifts to
appellant to show that it does not).
Accordingly, we affirm the Examiner’s rejection of claims 21 and 22.
Claim 23 based on Korthoff, Green ‘373, Hermes, and DeFonzo
Claim 23 recites a method for processing an instrument for surgery
comprising obtaining the stapler of claim 11, sterilizing the stapler, and
storing the stapler in a sterile container. The Examiner relied on Korthoff,
Green ‘373, and Hermes to disclose the stapler of claim 11 and DeFonzo to
disclose the claimed steps of sterilizing and packaging the stapling device as
a well-known means of preventing contamination of the devices and patients
on whom the device is used. Ans. 6-7.
As discussed supra, we agree with Appellants that Korthoff, Green
‘373, and Hermes do not disclose the surgical stapling system of claim 11
and DeFonzo does not cure this deficiency. Br. 39-40.
Accordingly, we cannot sustain the rejection of claim 23.
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DECISION
The Examiner’s decision to reject claims 1, 3-6, 8-20, 24, 25, and 29-
36 under 35 U.S.C. § 103(a) as being unpatentable over Korthoff, Green
‘373, and Hermes is REVERSED.
The Examiner’s decision to reject claims 26-28 and 37-39 under 35
U.S.C. § 103(a) as being unpatentable over Green ‘250 and Green ‘445 is
REVERSED.
The Examiner’s decision to reject claims 21 and 22 under 35 U.S.C.
§ 103(a) as being unpatentable over Green ‘250 and Green ‘445 is
AFFIRMED.
The Examiner’s decision to reject claim 23 under 35 U.S.C. § 103(a)
as being unpatentable over Korthoff in view of Green ‘373 and Hermes, as
applied to claim 11, and further in view of DeFonzo is REVERSED.
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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