Ethicon, Inc.

Patent Trials and Appeals Board

Oct 26, 2020

14177894 - (D) (P.T.A.B. Oct. 26, 2020)

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.
14/177,894 02/11/2014 Anthony Miksza ETH5764USNP 1467
73119 7590 10/26/2020
Doherty IP Law Group LLC
37 Belvidere Avenue
Washington, NJ 07882
EXAMINER
BACHMAN, LINDSEY MICHELE
ART UNIT PAPER NUMBER
3771
MAIL DATE DELIVERY MODE
10/26/2020 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 ANTHONY MIKSZA, ROBERT NERING,
MARK D. KENYON, OMAR J. VAKHARIA, and
DENNIS D. JAMIOLKOWSKI
Appeal 2020-001737
Application 14/177,894
Technology Center 3700
Before JILL D. HILL, LEE L. STEPINA, and
ARTHUR M. PESLAK, Administrative Patent Judges.
STEPINA, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1–27. See Final Act. 1. We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R.
§ 1.42. Appellant identifies the real party in interest as Ethicon, Inc. Appeal
Br. 2.
Appeal 2020-001737
Application 14/177,894

2
CLAIMED SUBJECT MATTER
Appellant’s invention relates to systems, devices and methods that use
surgical fasteners for securing implants to tissue. Spec. ¶ 2. Claims 1 and
20–22 are independent. Claim 1, reproduced below with emphasis added, is
illustrative of the claimed subject matter:
1. An applicator system for surgical fasteners comprising:
a surgical fastener insertion tool having a body with a
proximal end, a distal end, a longitudinal axis extending between
the proximal and distal ends of said body, a top side extending
from the proximal end to the distal end of said body, a bottom
side extending from the proximal end to the distal end of said
body, and first and second lateral sides that extend from the
proximal end to the distal end of said body and between the top
and bottom sides of said body, said surgical fastener insertion
tool including an insertion fork connected to the distal end of
said body that extends laterally relative to the longitudinal axis
of said body, said insertion fork having a proximal end connected
to the distal end of said body, a distal end, and a curved shaft that
extends from the proximal end of said insertion fork to the distal
end of said insertion fork, wherein said curved shaft of said
insertion fork has a top surface that is concave and that faces in
the same direction as the top side of said body and a bottom
surface that is convex and that faces in the same direction as the
bottom side of said body;
at least one cartridge containing a plurality of surgical
fasteners, wherein said surgical fasteners are removed one at a
time from said cartridge by engaging one of said surgical
fasteners with said insertion fork and removing said engaged
surgical fastener from said cartridge.
Appeal Br. 23 (Claims Appendix).
REFERENCES
The prior art relied upon by the Examiner is:
Name Reference Date
Appeal 2020-001737
Application 14/177,894

3
Peiffer US 4,936,447 June 26, 1990
Esposito US 6,044,971 Apr. 4, 2000
Evans US 8,092,366 B2 Jan. 10, 2012
Doyle (“Doyle ’604”) US 2002/0111604 A1 Aug. 15, 2002
Nering US 2010/0292715 A1 Nov. 18, 2010
Euteneuer US 2012/0211543 A1 Aug. 23, 2012
Privitera US 2012/0323256 A1 Dec. 20, 2012
Doyle (“Doyle ’ 690”) US 2013/0184690 A1 July 18, 2013
REJECTIONS
I. Claims 1, 2, 10–12, 17, 22, and 252 are rejected under 35
U.S.C. § 103(a) as unpatentable over Euteneuer, Evans, and Peiffer.
II. Claims 3–9 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Euteneuer, Evans, Peiffer, Doyle ’604 and Doyle ’690.
III. Claims 13–16 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Euteneuer, Evans, Peiffer, and Nering.
IV. Claims 1, 18, 19, 21, and 26 are rejected under 35 U.S.C.
§ 103(a) as unpatentable over Euteneuer, Evans, and Esposito.
V. Claims 20 and 27 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Euteneuer, Evans, Peiffer, and Privitera.
VI. Claims 23 and 24 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Euteneuer, Evans, Peiffer, Doyle ’604, and Doyle ’690.

2 The Examiner’s omission of claim 2 from the heading of Rejection I
appears to be a typographical error in that claim 2 is discussed in the body of
the rejection. See Final Act. 4–5.
Appeal 2020-001737
Application 14/177,894

4
OPINION
Rejections I, IV and V
Each of independent claims 1 and 20–22 includes the limitations,
“said surgical fastener insertion tool including an insertion fork connected to
the distal end of said body that extends laterally relative to the longitudinal
axis of said body,” and requires that the insertion fork has “a curved shaft.”
Appeal Br. 23, 27–29 (Claims App.).
Appellant argues for the patentability of the claims subject to the first,
fourth, and fifth grounds of rejection, i.e., claims 1, 2, 10–12, 17–22, and
25–27, as a group, based on the above note limitations of the independent
claims. Appeal Br. 13–21. We select claim 1 as representative of the group,
and claims 2, 10–12, 17–21, and 25–27 stand or fall with claim 1. 37 C.F.R.
§ 41.37(c)(1)(iv). Appellant makes arguments based on the above-noted
limitations for independent claim 22, but because Appellant provides an
additional argument for claim 22, we address the additional argument under
a separate heading below.
In each rejection, the Examiner relies on the combined teachings of
Euteneuer and Evans for the above-noted limitations. See Final Act. 4–5.
For Rejection I, the Examiner also relies on Peiffer to reject independent
claims 1 and 22, but for limitations unrelated to the laterally extending
insertion fork. See Final Act. 5, 7–8. For Rejection IV, the Examiner also
relies on Esposito to reject independent claims 1 and 21, but for limitations
unrelated to the laterally extending insertion fork. See Final Act. 12 and 14.
For Rejection V, the Examiner also relies on Peiffer and Privitera to reject
independent claim 20, but for limitations unrelated to the laterally extending
insertion fork. See Final Act. 15–16.
Appeal 2020-001737
Application 14/177,894

5
Turning to the teachings of Euteneuer and Evans, the Examiner finds
that Euteneuer discloses a surgical fastener insertion tool having a body and
including an insertion fork connected to the distal end of the body. Id. at 4.
The Examiner finds that the insertion fork of Euteneuer does not extend
laterally relative to the longitudinal axis of said body and is not curved, but
the Examiner finds that Evans discloses an insertion tool having an insertion
part that extends laterally relative to the longitudinal axis of the insertion
tool body and is curved. Id. at 4–5. According to the Examiner, Evans
teaches adjusting the shape of the insertion tool depending on which part of
the body the insertion tool is used. Id. at 5. The Examiner concludes that it
would have been obvious to modify Euteneuer’s insertion fork to be curved
and extend laterally relative to the body “in order to access a particular part
of the body.” Id.
Appellant summarizes Euteneuer and Evans and then sets forth
several reasons why the Examiner has allegedly failed to establish a prima
facie case of obviousness. Appeal Br. 13–17.
First, Appellant argues that Euteneuer’s insertion fork tines 134A,
134B must align with pilot holes 162A, 162B that are pre-formed in tissue T.
Appeal Br. 17. According to Appellant, an insertion fork having a “curved
shaft,” would not align with pilot holes that are axially extending, and would
not advance properly into the pilot holes. Id.
Second, Appellant argues that modifying Euteneuer so that tines
134A, 134 B extend laterally would prevent proper operation of staple push
rod 130. Id. Specifically, Appellant asserts that because Euteneuer teaches
that staple push rod 130 moves distally along axis D, Euteneuer would not
Appeal 2020-001737
Application 14/177,894

6
function properly if the two insertion tines 134A, 134B are curved and
extended laterally from the body. Id. at 19.
Third, Appellant argues that because Euteneuer’s tines extend along
the longitudinal axis of staple push rod 130 for axially movement, “if
Euteneuer’s tines were curved as suggested by the Examiner, the tines would
be unable to advance the legs of the staple into the axially-extending pilot
holes that are pre-formed in the tissue T.” Id. at 20 (citing Euteneuer, Fig.
12C). Moreover, according to Appellant, Euteneuer’s longitudinally
extending tool teaches away from a combination with an axially extending
tool. Id.
The Examiner responds that the modification does not merely turn
Euteneuer’s existing insertion tool laterally. Ans. 5. Rather, one of ordinary
skill would understand that, based on the teachings of Evans, the
modification would be to “the entire tool shaft of [Euteneuer], including
both the outer shaft 146 and the inner insertion tool body 132, to both have
the same curvature such that after modification, both shafts continue to be
coaxial with one another, as in [Euteneuer].” Id. Thus, according to the
Examiner, Euteneuer’s modified device would continue to function as
intended. Ans. 6.
The Examiner finds that Euteneuer does not teach away from the
proposed combination because Euteneuer does not require that the push rod
and tines must extend in a particular direction, only that they both extend in
the same direction. Ans. 7. According to the Examiner, by modifying
Euteneuer’s entire tool shaft to extend laterally and be curved, Euteneuer
continues to function in the manner intended, and has the added benefit of a
curved shaft for easier surgeon access to a body part. Id.
Appeal 2020-001737
Application 14/177,894

7
In reply, Appellant disagrees that Euteneuer’s modified device would
continue to function as intended. Reply Br. 2. Appellant contends that
Euteneuer teaches a distally directed force F that is continuously applied
during staple insertion. Id. at 2–3 (citing Euteneuer, ¶¶ 77, 79–80; Figs.
12A–12C). According to Appellant,
it would not be obvious to one skilled in the art to extend
Euteneuer’s shaft 146 laterally because an operator would not be
able to generate the force F that is necessary to form the pilot
holes in the tissue and to maintain the force F on the tissue as the
legs of the staple 100 are advanced into the pre-formed pilot
holes 162A, 162B. If Euteneuer’s shaft 146 were extended
laterally, an operator of Euteneuer’s device would have to twist
or rotate the handle to generate a lateral force. This would clearly
change the principle of operation of Euteneuer.
Id. at 3.
We disagree with Appellant’s arguments because Appellant provides
no technical explanation or argument sufficient to establish that one of
ordinary skill in the art would consider that the modified Euteneuer would
not be able to generate sufficient force F. Rather, Appellant merely
speculates that the force applied in the proposed device would be insufficient
to form the required holes in the patient’s tissue. Reply Br. 3. The curved
and laterally extending device in the Figure 11 embodiment of Evans, upon
which the examiner relies, generates sufficient force to urge the introducer
and anchor (staple) into tissue, and maintains the force until the anchor is
released from the introducer using a button. See Evans, 8:1–12, 8:57–62;
see also Final Act. 4–5. Appellant’s attorney argument, without more, does
not apprise us of any reason as to why a similarly sufficient force would not
be achieved by the modified version of Euteneuer proposed by the
Examiner.
Appeal 2020-001737
Application 14/177,894

8
We also disagree with Appellant’s arguments (see Appeal Br. 17–20)
relating to inoperability, change in the principle of operation, and teaching
away. As the Examiner explains, the modification entails making the entire
shaft of Euteneuer curved and laterally extending, which would align the
staple with the pilot holes and would allow proper operation of staple push
rod 130, as evidenced by Evans. Evans, 8:60–62 (“an introducer needle 111
with a halo-shaped needle shaft 110, a handle 112 and a button 113 for
releasing the anchor 1 from the distal end of the needle.”). The modified
version of Euteneuer would still function to introduce staples into tissue and
would perform this function using the same principle of operation, namely,
by using a tool to push a fastener into tissue. The fact that the pushing
action required results from a “bent” device does not change the principle of
operation. Appellant’s speculation that the modified device would require
the operator “to twist or rotate the handle to generate sufficient force” and
that “this would clearly change the principle of operation of Euteneuer”
(Reply Br. 3) is unavailing because (i) Appellant does not provide evidence
or technical argument establishing that such twisting and rotation would
actually be necessary, and (ii) even if required, such twisting and rotation
would not change the principle of operation of Euteneuer’s device (pushing
a fastener into tissue).
As to Appellant’s argument that Euteneuer teaches away from the
proposed combination, we agree with the Examiner that Euteneuer does not
require that the push rod and tines extend only in the longitudinal direction,
and it is sufficient that they merely extend in the same direction. Ans. 7.
Appellant does not identify any portion of Euteneuer that teaches away from
the claimed arrangement, e.g., by criticizing, disparaging, or discouraging
Appeal 2020-001737
Application 14/177,894

9
pursuit of the claimed arrangement. See In re Fulton, 391 F.3d 1195, 1201
(Fed. Cir. 2004). Rather, Appellant’s contention on this point appears to be
based on the unpersuasive contention, discussed above, that only a
longitudinal force is sufficient for implanting a staple. Appeal Br. 20.
We have considered all of Appellant’s arguments in support of the
patentability of claim 1, but find the Examiner has the better position. For
these reasons, we sustain the rejection of claim 1. Claims 2, 10–12, 17–21,
and 25–27 fall with claim 1.
Claim 22
Appellant includes an additional argument in support of claim 22. See
Appeal Br. 21. Appellant alleges the Examiner erred in making a factual
finding regarding Evans. In its entirety, Appellant’s argument is that “[i]n
Evans, the shaft 110 (FIG. 11) is not connected to the distal end face of the
handle 112, and it is not ‘connected to the first lateral side’ of the handle as
required by the limitations found in independent claim 22.” Id.
Claim 22, recites, in part, “said insertion fork having a proximal end
connected to the first lateral side of said body at the distal end of said body.”
Appeal Br. 29 (Claims App.). The Examiner finds that Evans’s insertion
tool “has a body (110, 112) with a longitudinal axis and an insertion part
(unlabeled, called ‘halo-shaped needle’ in specification) that extends
laterally from the distal end of the body relative to the longitudinal axis of
the insertion tool body and is curved.” Final Act. 5 (citing Evans, Fig. 11);
see also Evans 6:63–67.
Given that the Examiner finds that elements 110 and 112 of Evans,
together, meet the claimed body, and given that Evans’s insertion fork (halo-
shaped needle) has a proximal end connected to the first lateral side of body
Appeal 2020-001737
Application 14/177,894

10
110 at a distal end of body 110, Appellant’s argument regarding only the
connection at the end face of handle 112 does not address the findings of
fact made by the Examiner. In other words, Appellant’s argument does not
address the rejection as presented, and, therefore, does not identify Examiner
error. Accordingly, we sustain the rejection of claim 22.

Rejections II, III, and VI
Claims 3–9, 13–16, 23, and 24 depend from one of claims 1 and 22.
Appellant does not make arguments for the patentability of claim 3–9, 13–
16, 23, and 24 aside from those discussed above regarding claims 1 and 22.
See Appeal Br. 21. Accordingly, for the same reasons, we sustain
Rejections II, III, and VI.
CONCLUSION
The Examiner’s rejections are affirmed.
Appeal 2020-001737
Application 14/177,894

11
DECISION SUMMARY
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 2, 10–12,
17, 22, 25
103 Euteneuer, Evans,
Peiffer
1, 2, 10–12,
17, 22, 25

3–9 103 Euteneuer, Evans,
Peiffer, Doyle ’604,
Doyle ’690
3–9
13–16 103 Euteneuer, Evans,
Peiffer, Nering
13–16
1, 18, 19,
21, 26
103 Euteneuer, Evans,
Esposito
1, 18, 19,
21, 26

20, 27 103 Euteneuer, Evans,
Peiffer, Privitera
20, 27
23, 24 103 Euteneuer, Evans,
Peiffer, Doyle ’604,
Doyle ’690
23, 24
Overall
outcome:
1–27

TIME PERIOD FOR RESPONSE
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