Ex Parte Milliman et al

Patent Trial and Appeal Board

Aug 26, 2016

12203245 (P.T.A.B. Aug. 26, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/203,245 09/03/2008
50855 7590 08/30/2016
Covidien LP
555 Long Wharf Drive
Mail Stop SN-I, Legal Department
New Haven, CT 06511
FIRST NAMED INVENTOR
Keith L. Milliman
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
H-US-01023 (203-5707) 2797
EXAMINER
ANDERSON, GREGORY A
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
08/30/2016 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):
mail@cdfslaw.com
SurgicalUS@covidien.com
medtronic_mitg-si_docketing@cardinal-ip.com
PTOL-90A (Rev. 04/07)
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Exparte KEITH L. MILLIMAN and THOMAS R. HESSLER
Appeal2014-006430
Application 12/203,245
Technology Center 3700
Before LYNNE H. BROWNE, THOMAS F. SMEGAL, and
PAUL J. KORNICZKY, Administrative Patent Judges.
KORNICZKY, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF CASE
Appellants, Keith L. Milliman et al., 1 appeal under 35 U.S.C. § 134
from the Examiner's Final decision rejecting claims 1, 3, 4, 9, and 12-21.2
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
Appellants identify the real party in interest as Tyco Healthcare Group
LP. Appeal Br. 2.
2 Claims 1, 3, and 18 stand rejected by the Examiner, but are not
appealed by Appellants, and claims 2, 5-8, 10, and 11 are cancelled. Appeal
Br. 4.
Appeal2014-006430
Application 12/203,245
THE CLAIMED SUBJECT MATTER
The claims are directed to an insertion shroud for shielding a surgical
instrument during delivery of the surgical instrument to a surgical site.
Spec. 1:11-13. Claims 1, 12, and 18 are independent. Claim 12, reproduced
below, is illustrative of the claimed subject matter:
12. A shroud configured for use with a surgical instrument, the
shroud comprising:
a proximal portion, a distal portion, and a central body
portion,
the distal portion including a plurality of distal segments
which define a plurality of slits,
the distal segments being flexible to facilitate movement
of the shroud between first and second positions,
the proximal portion being flexible to enable a diameter of
the proximal portion to change during movement of the shroud
between the first and second positions,
the distal portion defining a rounded atraumatic distal
configuration,
the shroud being positioned on an elongated body portion
of a surgical instrument and being movable between the first
position in which a distal portion of the shroud extends beyond a
distal end of a tool assembly of the surgical instrument and the
second position in which the distal portion of the shroud is
positioned proximal to the distal end of the tool assembly.
REFERENCES
In rejecting the claims on appeal, the Examiner relied upon the
following prior art:
Brinkerhoff
Steffen
Fisher
us 5,404,870
us 2009/0204108
US 7,744,571 B2
2
Apr. 11, 1995
Aug. 13, 2009
June 29, 2010
Appeal2014-006430
Application 12/203,245
REJECTIONS
The Examiner made the following rejections:
1. Claims 1, 3, 9, and 18-21 stand rejected under 35 U.S.C. § 102(b)
as being anticipated by Brinkerhoff. 3
2. Claim 1 stands rejected under 35 U.S.C. § 102(e) as being
anticipated by Steffen. 4
3. Claims 4 and 12-17 stand rejected under 35 U.S.C. § 103(a) as
being unpatentable over Brinkerhoff and Fisher.
Appellants seek our review of these rejections.
OPINION
The Rejection of Claims 9 and 19-21 As Anticipated by Brinkerhoff
Claims 9 and 19
The Examiner finds that Brinkerhoff discloses all of the limitations of
claims 9 and 19. Final Act. 2. The Examiner states that "the distal end of
the shroud is rounded and a force is require to push the device through the
shroud, thus the shroud would remain in the first position due to the shape of
the distal end." Adv. Act. 2; see also Ans. 3 ("[W]hen the stapler 12 is
extended through the petals, the petals exert force on the sides of the stapler.
3 Appellants do not seek review of the rejections of claims 1, 3, and 18.
Appeal Br. 4. 37 C.F.R. § 41.3 l(c) provides that "[a]n appeal, when taken,
is presumed to be taken from the rejection of all claims under rejection
unless cancelled by an amendment filed by the applicant and entered by the
Office." Claims 1, 3, and 18 are not canceled. As such, the rejections of
these claims are before us on appeal. Because Appellants did not contest the
rejections of these claims in the Appeal Brief, we summarily sustain the
rejection of these claims.
4 See footnote 3.
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Appeal2014-006430
Application 12/203,245
This force creates friction that must be overcome and thus, given no external
force, or a force smaller than that of the friction force generated between the
petals 28 and the stapler 12, the nature of the petals trying to retract to their
relaxed state will hold the shroud in position on the stapler.").
Appellants argue that
Brinkerhoff clearly states the reason for the geometry of the
distal end of the shroud: "as distal end 26 is urged forward
against segments 28, the segments 28 deflect outward and allow
distal end 26 to advance beyond the inserter 10" (Column 3,
lines 15-18; emphasis added). That is, Brinkerhoff teaches that
the segments 28 adjacent the distal end of its inserter 10 are
configured to "allow" the distal end 26 of the instrument to
advance beyond the inserter 10; Brinkerhoff fails to teach any
feature that would "retain the shroud in the first position" where
"a distal portion of the shroud extends beyond a distal end of the
tool assembly," as recited in Claim 9, or that would "maintain
the shroud on the elongated body portion," as recited in Claim
19.
Reply Br. 7; see also Appeal Br. 14.
However, Brinkerhoff also discloses that distal end 26 of an
intraluminal anastomotic surgical stapler 12 ("ILS") (i.e., tool mechanism)
passes through inserter 10 (i.e., shroud) after flange 34 rests against the
perineal tissue surrounding the anus. Brinkerhoff2:67-3:18. Before flange
34 rests against the perineal tissue, Brinkerhoff states that "an intra-anal
device 12 is inserted into bore 24 stapler of transanal inserter 10 such that
the distal end 26 is positioned against the inner surface 22 at distal end
portion 18, as seen in FIG. 5. Inserter 10 and intra-anal device 12 are then
inserted through the anus until the distal surface 40 of flange 34 rests against
the perineal tissue surrounding the anus, and distal end portion 18 extends to
a predetermined depth within the colon or intestine as required by the
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Appeal2014-006430
Application 12/203,245
surgical procedure." Id. at 2:67-3:7. Fig. 5 discloses that distal end 18 of
inserter 10 extends beyond distal end 26 of ISL 12. Thus, before flange 34
engages the perineal tissue, the internal cylindrical structure of inserter 10 is
configured to engage the external cylindrical structure of ISL 12 and,
thereby, retain inserter 10 in a "first position" where "a distal portion of the
shroud extends beyond a distal end of the tool assembly," as recited in
claims 9 and 19.
Appellants' arguments do not show error by the Examiner. We
sustain the Examiner's rejections of claims 9 and 19.
Claim 20
The Examiner finds that Brinkerhoff s inserter 10 has proximal
opening 30 which is intended to receive a portion of a surgical instrument,
and that there is "an infinite variety of segments around the cylindrical
proximal section." Adv. Act. 2. The Examiner explains that
There is nothing in claim 20 to suggest that the proximal end of
the device has individual segmented portions defined by any
physical features, only that a series of segments exist. A solid
cylindrical tube (as the proximal end of the Brinkerhoff et al.
device is) can be delineated with an infinite variety of segments,
of varying shapes and sizes. The claim is not specific, and thus it
would not be reasonable for one to conclude that the term "series
of proximal segments" requires the segments to be separate from
each other in any way.
Ans. 3.
In response, Appellants argue that Brinkerhoff discloses "proximal
flange 34 of the inserter 10 of Brinkerhoff is solid and is comprised of a
single, non-segmented, piece of material; the flange 34 does not include a
series of segments, as claimed." Appeal Br. 15; see also Reply Br. 9.
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Appeal2014-006430
Application 12/203,245
Contrary to the Examiner's explanation and construction of the claim term
"segments" based thereon, the Specification describes "[p ]roximal segments
26 [that] are spaced apart to define slits 28, which allow proximal segments
26 to flex outwardly in relation to each other." Spec. 7: 19-21 (emphasis
added). In light of the teachings in the Specification, the Examiner's claim
construction is not reasonable, and one skilled in the art would not
understand that Brinkerhoff discloses "segments" as recited in claim 20. We
do not sustain the Examiner's rejection of claim 20.
Claim 21
The Examiner finds that Brinkerhoff s entire shroud is configured to
for endoscopic insertion into the body, as recited in claim 21. The Examiner
explains that
there is no disclosure in the Brinkerhoff et al. reference that
suggests the device cannot be used in procedures that require an
inserter fully inserted into the body and resting the flange against
an internal organ, further, the flange of the Brinkerhoff et al.
device is disclosed as pliable and as such the device can easily
be placed within an endoscope of appropriate size.
Adv. Act. 2 (emphasis added).
Contrary to the Examiner's findings, and as Appellants correctly state,
"Brinkerhoff discloses "that 'distal surface 40 [of flange 34], which rests
against the perineal tissue surrounding the anus, retains the inserter in place
and prevents over-insertion of inserter 10 beyond the anus.' (Column 3,
lines 12-15.)" Reply Br. 11 (emphasis added). The Examiner does not
identify any disclosure in Brinkerhoff or other support that evidences a
flange large enough to prevent over-insertion of inserter 10 into the anus can
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Appeal2014-006430
Application 12/203,245
also be small enough to "easily be placed within an endoscope." Adv. Act.
2. The Examiner's rejection of claim 21 is not sustained.
The Rejection of Claims 4 and 12-17
As Unpatentable Over Brinkerhoff and Fisher
Claim 4
With respect to claim 4, the Examiner finds that "it would have been
obvious ... to modify the device of Brinkerhoff et al. with the slits of Fisher
et al. in order to facilitate splitting the assembly to peel it away from the tool
as taught by Fisher et al." Adv. Act. 2.
In response, Appellants argue that "the alleged combination [of
Brinkerhoff and Fisher] would teach a shroud having slits to facilitate
removing the shroud from an instrument, rather than a shroud having slits
to facilitate positioning the shroud on an instrument." Reply Br. 14. If
flange 34 were peeled away from the tool, as suggested by the Examiner,
flange 34 would be unable to prevent over-insertion of inserter 10 into the
patient's anus. The Examiner's findings are in error, and we reverse the
Examiner's rejection of claim 4.
Claims 12-17
With respect to independent claim 12, the Examiner finds that the
"limitations of claim 12, which require the proximal end to change shape
during movement of the shroud between the first and second positions, are
met since the combination of Brinkerhoff et al. in view of Fisher et al. is
capable of being split and peeled away at any time during use of the device."
Ans. 4--5.
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Application 12/203,245
In response, Appellants argue that "the diameter of the [Brinkerhotl]
proximal portion (i.e., flange 34) does not change during movement of the
shroud between the first and second positions .... Rather, the size of the
flange remains constant to help ensure that flange 34 remains exterior to the
anus." Reply Br. 15. If flange 34 located on the proximal end of the shroud
were peeled away from inserter 10, as suggested by the Examiner, flange 34
would be unable to prevent over-insertion of inserter 10 into the patient's
anus. For these reasons, the Examiner's rejection of claim 12 and claims
13-17 which depend from claim 12 is not sustained.
Petitionable Matters
In the Reply Brief, Appellants argue for the first time that the
substantive bases for the Examiner's rejections of claims 9 and 19 were
improperly presented for the first time in the Advisory Action, mailed
September 9, 2011, instead of in the Final Action. Reply Br. 4--6. Whether a
Final Action is premature for failing to present the bases for all rejections is
a matter reviewable by petition under 3 7 C.F.R. § 1.181, not by appeal to the
Patent Trial and Appeal Board. 37 C.F.R. § 1.181; see, e.g., MANUAL OF
PATENT EXAMINING PROCEDURE (MPEP) §§ 1002.02(c)(3)(a) and
1201 (9th Ed., Rev. 7.2015, Last Revised November 2015).
DECISION
For the above reasons, the Examiner's rejections of claims 1, 3, 9, 18,
and 19 under 35 U.S.C. § 102(b) as being anticipated by Brinkerhoff are
AFFIRMED.
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Application 12/203,245
The Examiner's rejection of claim 1under35 U.S.C. § 102(e) as
being anticipated by Steffen is AFFIRMED.
The Examiner's rejections of claims 20 and 21 under 35 U.S.C.
§ 102(b) as being anticipated by Brinkerhoff are REVERSED.
The Examiner's rejections of claims 4 and 12-17 under 35 U.S.C.
§ 103(a) as being unpatentable over Brinkerhoff and Fisher are REVERSED.
No time period for taking any subsequent action in connection with
this appeal maybe extended under 37 C.F.R. § 1.136(a)(l)(iv) (2015).
AFFIRMED-IN-PART
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