Covidien LP

Patent Trials and Appeals Board

May 26, 2020

2019006173 (P.T.A.B. May. 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.
15/049,503 02/22/2016 Frank Viola H-
US-02355DIV(203-7045D)
4534
50855 7590 05/26/2020
Covidien LP
60 Middletown Avenue
Mailstop 54, Legal Dept.
North Haven, CT 06473
EXAMINER
DAVID, SHAUN L
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
05/26/2020 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
docket@carterdeluca.com
rs.patents.two@medtronic.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________

Ex parte FRANK VIOLA and GERALD HODGKINSON
____________

Appeal 2019-006173
Application 15/049,503
Technology Center 3700
____________

Before JAMES P. CALVE, WILLIAM A. CAPP, and
JEREMY M. PLENZLER, Administrative Patent Judges.

CAPP, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Appellant1 seeks our review under 35 U.S.C. § 134(a) of the final
rejection of claims 12–23. We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42(a). Appellant identifies Covidien LP as the applicant and real
party in interest. Appeal Br. 1.
Appeal 2019-006173
Application 15/049,503
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THE INVENTION
Appellant’s invention relates to surgical fasteners. Spec. ¶ 2.
Claim 12, reproduced below, is illustrative of the subject matter on appeal.
12. A method of inserting a surgical fastener to close an
opening through tissue, the method comprising:
providing an insertion instrument including a surgical
fastener integrally formed with and configured to break-away
from a distal end of the insertion instrument, the surgical
fastener having an open configuration and being closable;
inserting the distal end of the insertion instrument into the
opening through tissue;
approximating at least one of tissue or the distal end of the
insertion instrument towards the other of the distal end of the
insertion instrument or tissue;
retracting the insertion instrument proximally through the
opening such that legs of the surgical fastener engage tissue;
closing the surgical fastener within tissue;
disengaging the insertion instrument from the surgical
fastener such that the surgical fastener breaks-away from the
insertion instrument; and
withdrawing the insertion instrument from the opening.
THE REJECTIONS
The Examiner relies upon the following as evidence in support of the
rejections:
NAME REFERENCE DATE
Kawai US 4,950,258 Aug. 21, 1990
Tovey US 5,478,354 Dec. 26, 1995
Allen US 6,626,930 Bl Sept. 30, 2003
Ainsworth US 2005/0021054 Al Jan. 27, 2005
Bolduc US 2005/0187613 Al Aug. 25, 2005
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The following rejections are before us for review:
1. Claims 12, 14, 16, 17, 19, 20, 22, and 23 are rejected under 35
U.S.C. § 103 as being unpatentable over Ainsworth and Bolduc.
2. Claims 12 and 15 are rejected under 35 U.S.C. § 103 as being
unpatentable over Tovey and Bolduc.
3. Claims 13 and 21 are rejected under 35 U.S.C. § 103 as being
unpatentable over Ainsworth, Bolduc, and Allen.
4. Claim 18 is rejected under 35 U.S.C. § 103 as being unpatentable
over Ainsworth, Bolduc, and Kawai.
OPINION
Unpatentability of Claims 12, 14, 16, 17, 19, 20, 22, and 23
over Ainsworth and Bolduc
Claim 12, 14, 16, 17, 19, and 23
The Examiner finds that Ainsworth discloses the invention of
claim 12 substantially as claimed except for the break-away feature, for
which the Examiner relies on Bolduc. Final Act. 3–4. The Examiner
concludes that it would have been obvious to a person of ordinary skill in the
art at the time of the invention to include a break-away feature in Ainsworth.
Id. at 4. According to the Examiner, a person of ordinary skill in the art
would have done this, among other things, to require a deliberate act by the
physician as a final step to the implantation process. Id. at 5.
Appellant argues that a person of ordinary skill in the art would not
have combined the teachings of Ainsworth and Bolduc to achieve the
claimed invention. Appeal Br. 3. According to Appellant:
[T]he particular manner in which a fastener is implanted greatly
effects retrievability of the fastener, and options available for
retrieving the fastener.
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Id. at 6.
In response, the Examiner finds that the proposed combination would
prevent inadvertent release of Ainsworth’s clip. Ans. 7. According to the
Examiner, the only thing preventing the clip from sliding out of the insertion
instrument is engagement by the clip holder’s arms. Ans. 6.
In reply, Appellant considers the Examiner’s concern regarding
inadvertent release of the clip “unrealistic.” Reply Br. 3.
Ainsworth is directed to a surgical clip for sealing perforations in
body organs or vessels. Ainsworth ¶ 1. Ainsworth discloses clip 510 that
resembles a staple in shape and has piercing members 501 on the ends of
each leg of the staple. Id. ¶ 54, Figs. 5A–C. In order to deliver and engage
clip 510, Ainsworth discloses clip holding and release mechanism 600 which
is placed in sheath 301 of clip delivery apparatus 300. Id. ¶ 59. Clip release
mechanism 600 comprises actuator controller 620 with clip holder 611
slidably mounted in bore 621. Id. Ainsworth also discloses clip delivery
apparatus 300, which is secured to the proximal end of clip holder 611. Id.
Controller 620 and delivery apparatus 300 have corresponding slots to
slidingly accommodate the legs of clip 510. Id. ¶ 59, Figs. 6, 7. Clip
holder 611 comprises a spring clamp with arms 602 that hold clip 510. Id.
¶ 61, Figs. 6, 7. In operation, inner wall surfaces 650 of body member 620
bias the clamp to a closed position. Id. As clip holder 611 is retracted, the
clamp arms relax, thereby allowing the clip to pass through. Id. ¶¶ 61–67,
Figs. 8A–E.
Bolduc is directed to deployment of a prosthesis into a blood vessel or
hollow body organ. Bolduc, Abstract. Bolduc’s prosthesis 10 features
fastening region 26 that accommodates fasteners 28 to anchor the prosthesis
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in place. Id. ¶ 72. Fastener 28 is deployed into tissue by means of
applier 38 that includes carrier 128. Id. ¶ 124, Figs. 16A–C. Applier 38
includes tether 140 which connects fastener 28 to applier 38 even after
fastener 28 has otherwise been separated from applier 38. Id. ¶ 132,
Fig. 17A. Tether 140 serves as a “life line,” maintaining a connection of last
resort between applier 38 and fastener 28. Id. Tether 140 allows fastener 28
to be retrieved after implantation. The connection between tether 140 and
applier 38 requires a deliberate act of the physician to be broken, adding a
confirming, final step to the implantation process. Id. ¶ 132, Fig. 17B.
In the instant case, claim 12 is a method claim. Claims App. In the
claimed method, the legs of Appellant’s surgical fastener engage tissue when
the insertion instrument is being retracted. Spec. ¶¶ 41–43 Figs. 6–10. This
step in the claimed method is recited as follows:
retracting the insertion instrument proximally through the
opening such that legs of the surgical fastener engage tissue.
Claims App. In Appellant’s invention, the distal end of tapered extension 64
is integrally formed with faster 110 and is configured to break-away from
fastener 110. Spec. ¶ 39, Fig. 5. The detachable connection is configured to
operate in connection with deploying the legs of the fastener via a pulling
motion and accompanying force. The design of the detachable connection,
therefore, contemplates detachment after tissue engagement using a pulling
motion and accompanying force. Thus, both: (1) tissue engagement; and
(2) separation of the detachable connection; are accomplished with pulling
motions and accompanying forces.
In contrast, Bolduc’s spiral fastener is deployed using rotational
motion and an accompanying “pushing” force. Bolduc ¶¶ 125–130. After
deployment and implantation in tissue, fastener 28 automatically separates
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from carrier 128, except for tether 140. Bolduc ¶¶ 125–133. Tether 140 is
frangible and is separated from fastener 128 by force. Id. ¶ 133.
Thus, Appellant’s break-away feature is integrated into its mechanism
for engaging tissue. Bolduc’s frangible tether element is not. Operation of
Bolduc’s frangible tether “life line” entails motions and forces in the
opposite direction of that involved with engaging tissue. Taking the
foregoing into account, we are unable to agree with the Examiner’s position
that a person of ordinary skill in the art would have been motivated to
modify Ainsworth with Bolduc’s “life line” feature. Operating Bolduc’s
“life line” in Ainsworth would necessarily entail applying a pulling force on
the tether that acts in the same direction as the pulling force that engages
Ainsworth’s clip. Ainsworth ¶¶ 58–66, Figs. 6–8E.
Given the manner in which Ainsworth deploys its clip by penetrating
an incision with an entire assembly comprising holder 611, controller 620,
clip 510, and delivery apparatus 300, and then engaging tissue via retraction
where clip 510 remains imbedded in tissue and the remainder of the
assembly is retracted through the incision, we are unable to ascertain when,
if ever, a Bolduc “life line” would contribute to the successful operation of
Ainsworth. The Examiner’s concern regarding “inadvertent premature
retraction” in Ainsworth cannot be reconciled with the actual structure and
method of operation disclosed by Ainsworth. Ans. 6. Retraction that is
performed before clip 510 engages tissue would result in no deployment of
the clip and recovery of the entire assembly including the clip. Retraction
that is performed after clip 510 engages tissue would render any “life line”
incapable of recovering the clip.
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“An obviousness determination requires finding that a person of
ordinary skill in the art would have been motivated to combine or modify the
teachings in the prior art and would have had a reasonable expectation of
success in doing so.” Regents of Univ. of Cal. v. Broad Inst., Inc., 903
F.3d 1286, 1291 (Fed. Cir. 2018). The mere fact that the prior art may be
modified in the manner suggested by the Examiner does not necessarily
make the modification obvious. In re Fritch, 972 F.2d 1260, 1266 (Fed.
Cir. 1992). The Examiner’s alleged motivation for making the proposed
modification lacks rational underpinning. See In re Kahn, 441 F.3d 977, 988
(Fed. Cir. 2006)(requiring an obviousness conclusion to be based on explicit
articulated reasoning with rational underpinning) cited with approval in KSR
Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) .
In view of the foregoing, we do not sustain the Examiner’s
unpatentability rejection of claim 12.
Claims 14, 16, 17, 19, and 23
These claims depend from claim 12. Claims App. The Examiner’s
rejection of these claims suffers from the same infirmity that was identified
above with respect to claim 12 and, for essentially the same reason
expressed above in connection with claim 12, we do not sustain the rejection
of claims 14, 16, 17, 19, and 23.
Claims 20 and 22
Claim 20 is an independent claim that is substantially similar in scope
to claim 12. Claims App. The Examiner’s rejection of these claims suffers
from the same infirmity that was identified above with respect to claim 12.
Thus, we do not sustain the rejection of claims 20 and 22.
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Unpatentability of Claims 12 and 15
over Tovey and Bolduc
In this ground of rejection, the Examiner, once again, relies on
Bolduc’s life line feature. Final Act. 8–9. However, Tovey’s fastener
engages tissue via a pulling motion much in the same manner as Ainsworth
discussed above. Tovey, col. 6, ll. 60–67, Fig. 27. Thus, the Examiner’s
rejection of these claims suffers from essentially the same infirmity that was
identified above with respect to the grounds of rejection of claim 12 over
Ainsworth discussed above. Accordingly, we do not sustain the rejection of
claims 12 and 15.
Unpatentability of Claims 13 and 21
over Ainsworth, Bolduc, and Allen
Claim 13 depends from claim 12 and claim 21 depends from claim 20.
Claims App. The Examiner’s reliance on Allen for the vacuum element of
claim 13 does not cure the “life line” deficiency that we have previously
discussed. Final Act. 10. We do not sustain the Examiner’s unpatentability
rejection of claims 13 and 21.
Unpatentability of Claim 18
over Ainsworth, Bolduc, and Kawai
Claim 18 depends from claim 12. Claims App. The Examiner’s
reliance on Kawai for the shape memory heating element of claim 18 does
not cure the “life line” deficiency that we have previously discussed. Final
Act. 11. We do not sustain the Examiner’s unpatentability rejection of
claim 18.
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CONCLUSION
Claims
Rejected
§ References Aff’d Rev’d
12, 14, 16, 17,
19, 20, 22, 23
103 Ainsworth, Bolduc 12, 14, 16, 17
19, 20, 22, 23
12, 15 103 Tovey, Bolduc 12, 15
13, 21 103 Ainsworth, Bolduc, Allen 13, 21
18 103 Ainsworth, Bolduc, Kawai 18
Overall
Outcome
12–23
REVERSED