Ex Parte Zeiner et al

Patent Trial and Appeal Board

Sep 25, 2014

12113829 (P.T.A.B. Sep. 25, 2014)

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.
12/113,829 05/01/2008 Mark S. Zeiner END-6296 1801
21884 7590 09/26/2014
WELSH FLAXMAN & GITLER LLC
2000 DUKE STREET, SUITE 100
ALEXANDRIA, VA 22314
EXAMINER
WEEKS, GLORIA R
ART UNIT PAPER NUMBER
3721
MAIL DATE DELIVERY MODE
09/26/2014 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 S. ZEINER, MICHAEL J. STOKES, JASON L. HARRIS,
DANIEL E. ALESI, and LAWRENCE CRAINICH
____________

Appeal 2012-005016
Application 12/113,8291
Technology Center 3700
____________

Before STEFAN STAICOVICI, EDWARD A. BROWN, and
JILL D. HILL, Administrative Patent Judges.

BROWN, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
This is a decision on appeal under 35 U.S.C. § 134 from the
Examiner’s rejection of claims 1–4, 10, 11, and 13–17. We have jurisdiction
under 35 U.S.C. § 6(b).
We affirm-in-part.

1 According to Appellants, the real party in interest is Ethicon Endo-
Surgery, Inc. Br. 1.
Appeal 2012-005016
Application 12/113,829

2
Claimed Subject Matter
Claims 1 and 13 are independent. Illustrative claim 1 reads as
follows:
1. A low-profile surgical stapler that enables a large-
sized staple to be delivered into a body cavity through a small
opening or port, comprising:
a handle having a trigger movably coupled to the handle;
an elongated, tubular shaft having a longitudinal axis and
extending distally from the handle, the tubular shaft includes a
proximal end secured to the handle and a distal end in which a
deployment opening is formed;
a staple deploying assembly is disposed within an interior
of the shaft for discharging staples from the deployment
opening at the distal end of the shaft, the staple deploying
assembly supporting a staple such that a longitudinal axis of the
staple is aligned with a longitudinal axis of the shaft, the staple
having a length dimension bigger than a diameter of the shaft,
the staple, prior to deployment, includes a long body segment
having a longitudinal axis and first and second prongs, with
sharpened end tips, extending transversely from opposite ends
of the body segment;
wherein the deployment opening is shaped and
dimensioned to permit deployment of the staples from within
the shaft, out of the deployment opening and into adjacent
tissue.

Rejections
I. Claims 1–4, 10, 11, 13, and 14 stand rejected under 35 U.S.C.
§ 103(a) as being unpatentable over Mastri (US 5,782,396, issued July 21,
Appeal 2012-005016
Application 12/113,829

3
1998), Melling (US 5,820,009, issued Oct. 13, 1998), and Durrani (US
7,401,720 B1, issued July 22, 2008).2
II. Claims 15–17 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Mastri, Melling, Durrani, and Cook (US 5,342,396, issued
Aug. 30, 1994).

ANALYSIS
Rejection I
Claims 1–4
Claim 1 recites a low-profile stapler comprising, inter alia, “an
elongated tubular shaft” and “a staple deploying assembly . . . supporting a
staple such that a longitudinal axis of the staple is aligned with a longitudinal
axis of the shaft, the staple having a length dimension bigger than a
diameter of the shaft.” Emphasis added.
The Examiner finds that Mastri discloses a surgical stapler comprising
an elongated tubular shaft 30 (110, 120) having a deployment opening
dimensioned to permit deployment of staples 132, and a staple deploying
assembly 34. Answer 4–5. The Examiner determines that Mastri does not
disclose the dimensions of the tubular shaft or of staples capable of use with
the surgical stapler. Id. at 5.

2 The statement of the rejection lists claims 1–8, 13, and 14. Answer 4.
However, the Examiner indicates that the Answer should be amended to
remove claims 5–8 as rejected claims. See Office Commun. mailed Feb. 14,
2012. The Examiner indicates that claims 10 and 11 are also rejected under
this ground of rejection (Answer 9–10), and Appellants present arguments
for these claims (Appeal Br. 16–19). Accordingly, we consider this
rejection as pertaining to claims 1–4, 10, 11, 13, and 14.
Appeal 2012-005016
Application 12/113,829

4
The Examiner also finds that Melling discloses a stapler comprising a
tubular shaft 30 with a cross-sectional diameter “within the range of 5mm,
preferably.” Answer 5. The Examiner concludes that it would have been
obvious to one of ordinary skill in the art to modify the tubular shaft of
Mastri’s stapler to have a diameter of 5 mm or less because Melling “states
that such a modification permits the tubular shaft to fit within commercially
available cannulas.” Id. (citing Melling, col. 7, ll. 5–12).
The Examiner finds that Durrani discloses surgical staples having a
length of 7.5–10.5 mm. Answer 5. The Examiner concludes that it would
have been obvious to modify the cartridge slots and bending arms of Mastri
to have a length sufficient to support staples of a length in the range of 7.5–
10.5 mm, because Durrani suggests that such a modification would
configure the surgical stapler of Mastri for use in surgical stapling operations
of large animals. Id. The Examiner determines that the combination of
Mastri, Melling, and Durrani provides a surgical instrument in which “the
length of the staples is greater than the diameter of the shaft, as claimed.”
Id. at 6. The Examiner also determines that it is well known in the art to use
surgical staplers of a minimal diameter to minimize tissue invasion and
effectively position the stapler within a body to administer a fastener, and
fasteners of a length of 7.5–10.5 mm can secure thicker tissue. Id. at 8–9.
Appellants contend that the Examiner’s combination overlooks that
the claimed invention “lies in the relationship between the length dimension
of the staple and the diameter of the shaft.” Appeal Br. 12. Appellants
acknowledge that Melling discloses a specific shaft size and a desire to
provide a small-shafted medical instrument for passage through tubular
shafts, but contend that Melling does not appreciate problems associated
Appeal 2012-005016
Application 12/113,829

5
with providing a large staple in combination with such shaft. Id. at 12, 13.
Appellants acknowledge that Durrani discloses a specific staple size (i.e., a
length of 7.5–10.5 mm), but contend that Durrani does not appreciate the
need for providing such staples in conjunction with a low-profile instrument.
Id. at 13.
Appellants also contend that the Examiner does not explain how the
modification of Mastri would be achieved, and that the size of relative
components oftentimes creates problems in engineering design. Reply Br.
2–3.
Appellants’ contentions are not persuasive. The Examiner has
articulated an adequate reasoning with rational underpinnings to combine the
teachings of Mastri, Melling, and Durrani to result in the claimed surgical
stapler. Appellants do not provide any persuasive argument or technical
evidence to show that the Examiner’s combination of teachings would
require more than ordinary skill. In this regard, Appellants do not provide
any persuasive reason why Mastri’s shaft could not be modified by one
skilled in the art to have a diameter smaller than the length dimension of
staples used in the stapler. Appellants do not indicate what particular
engineering design problems would have to be overcome, or why one skilled
in the art would be unable to overcome them. In addition, Appellants do not
provide any persuasive argument or technical evidence to show that Mastri’s
stapler could not be used with a “staple having a length dimension bigger
than a diameter of the shaft,” as claimed. For example, Appellants do not
Appeal 2012-005016
Application 12/113,829

6
persuasively explain why the lengths of retention slots 146 and pushers 134,
and staples 132 could not be varied in the stapler of Mastri.3
In view of the above, we sustain the rejection of claim 1.
Claim 2, which depends from claim 1, recites that “the shaft has a
diameter that is less than approximately 5mm.” As discussed above, the
Examiner finds, and Appellants acknowledge, that Melling discloses a shaft
having a diameter within the claimed range. Appeal Brief 1314.
Appellants rely on substantially the same arguments discussed above for the
rejection of claim 1 for patentability of claim 2. Id. Appellants do not
provide any persuasive argument or technical evidence to show that the
claimed shaft diameter provides any advantage or unexpected result.
Accordingly, we also sustain the rejection of claim 2.
Appellants do not provide separate argument for claims 3 and 4,
which depend directly or ultimately from claim 1. Thus, we sustain the
rejection of claims 3 and 4 for the same reasons as those discussed for claim
1.
Claims 10 and 11
Claim 10, which depends from claim 1, recites that the surgical stapler
“further include[s] a staple . . . the staple, prior to deployment, includes a
long body segment . . . wherein the body segment includes a box at a center
of the staple.” Emphasis added.

3 In fact, Mastri discloses that apparatus 10 can operate with staples of
different lengths. See col. 9, ll. 14–18.
Appeal 2012-005016
Application 12/113,829

7
The Examiner finds that claim 10 is drawn to a staple capable of being
used by the stapler of Mastri, rather than to structural limitations of the
claimed surgical stapler. Answer 6; see also id. at 9–10.
Appellants contend that the Examiner does not explain where Mastri,
Melling, or Durrani discloses “a staple having a body segment with ‘a box at
a center of the staple.’” Appeal Br. 17. Appellants also contend that claim
10 claims a surgical stapler with a staple, and thus, the Examiner cannot
ignore the claimed staple structure. Id. at 18.
Appellants’ contentions are persuasive. Claim 10 is directed to a
surgical stapler that includes “a staple” as a structural element. The
Examiner’s determination that “claim 10 is drawn to a staple capable of
being used by the claimed surgical stapler” (Answer 9) is incorrect.
Accordingly, because the Examiner does not make a finding that the
combination of Mastri, Melling, and Durrani discloses a staple as recited in
claim 10, or articulate a reason with a rational underpinning why one skilled
in the art would have modified the combination to include the claimed
staple, we do not sustain the rejection of claim 10.
We also do not sustain the rejection of claim 11, which depends from
claim 10.
Claim 13
Claim 13 is directed to a low-profile surgical stapler “wherein the
deployment opening is at a distal tip of the shaft.”
Appellants contend that the Examiner’s rejection provides no
explanation regarding the positioning of the deployment opening at a distal
tip of the shaft. Appeal Br. 19. “Appellants presume the deployment
Appeal 2012-005016
Application 12/113,829

8
opening is considered to be element 146 of Mastri,” which Appellants
contend is not at the distal tip of the shaft. Id. at 19–20.
However, the Examiner provides an annotated version of Figure 3 of
Mastri, which includes the annotations “DEPLOYMENT OPENING” and
“ELONGATED TUBULAR SHAFT.” Answer 6. These annotations
correspond to features of elongate channel 110. See Mastri, col. 11, ll. 11–
15.
Appellants do not address the Examiner’s finding for the location of
the deployment opening in Mastri’s stapler. Thus, Appellants do not provide
any persuasive argument as to why the deployment opening shown in the
annotated figure is not in the distal tip of the shaft. As Appellants do not
apprise us of any error in the Examiner’s findings or reasoning as to claim
13, we sustain the rejection of this claim.
Claim 14
Claim 14, which depends from claim 13, recites that “the staple
deploying assembly includes an anvil including a center support that
engages the staple to hold the staple during transport through the shaft.”
The Examiner finds that Mastri’s “anvil 36 has a central portion
spaced from the edges of the anvil against which staples l32 are deformed as
the staples pass from the cartridge 34 of shaft 30.” Answer 7.
Appellants contend that the Examiner fails to explain “what is the
center support of the anvil 36 or how the center support engages the staple to
hold the staple during transport through the shaft.” Appeal Br. 20.
Appellants’ contention is persuasive. Mastri discloses “an anvil 36
against which staples are driven when ejected from their staple cartridge.”
See Mastri, col. 9, ll. 28–30; Fig. 1. Anvil 36 is shown to pivot toward
Appeal 2012-005016
Application 12/113,829

9
staple cartridge 34. Compare Figs. 9, 10. We agree with Appellants that the
Examiner does not identify “a center support [of anvil 36] that engages the
staple to hold the staple during transport through the shaft” as claimed.
Thus, we do not sustain the rejection of claim 14.
Rejection II
Claims 15–17 depend from claim 14. The Examiner determines that it
would have been obvious in view of Cook to modify Mastri’s anvil to
including bending guides. Answer 7. However, the Examiner’s application
of Cook for the rejection of claims 15–17 does not cure the deficiencies of
the rejection of claim 14 discussed above. Thus, we do not sustain the
rejection of claims 15–17.

DECISION
We affirm the rejection of claims 1–4 and 13, and reverse the
rejection of claims 10, 11, and 14–17.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).

AFFIRMED-IN-PART

llw