Ex Parte Berez et al

Patent Trial and Appeal Board

Jun 18, 2018

13550137 (P.T.A.B. Jun. 18, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO.
13/550, 137
137574
Medtronic
Medtronic
7590
826 coal creek circle
louisville, CO 80027
FILING DATE FIRST NAMED INVENTOR
07/16/2012 Aaron Lee BEREZ
06/20/2018
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-KN-02022USCON3 3863
EXAMINER
HOUSTON, ELIZABETH
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
06/20/2018 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):
rs. patents. two@medtronic.com
docketing@fortemip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte AARON LEE BEREZ and QUANG QUOC TRAN
Appeal2017-007058
Application 13/550,137 1
Technology Center 3700
Before DONALD E. ADAMS, FRANCISCO C. PRATS, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL
This Appeal under 35 U.S.C. § 134(a) involves claims 1--4, 7-13,
15-18, and 20-26 (App. Br. 3). Examiner entered rejections under 35
U.S.C. § 103(a). We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
1 Appellants identify "Covidien LP and its corporate owner, Medtronic, Inc."
as the real party in interest (App. Br. 3).
Appeal2017-007058
Application 13/550, 137
STATEMENT OF THE CASE
Appellants' disclosure "relates to a system and method for delivering
and deploying an endoluminal therapeutic device within the vasculature of a
patient to embolize and occlude aneurysms, particularly cerebral aneurysms"
(Spec. ,r 2). Claims 1, 11, and 16 are representative and reproduced below:
1. A system for delivering a self-expanding device, the system
compnsmg:
a sheath comprising an inner wall and a lumen surrounded by
the inner wall;
a self-expanding device; and
an assembly comprising an elongate flexible member, a
plurality of arms coupled at a first end to the elongate
flexible member, and a protective coil coupled to the
elongate flexible member distal of the arms, the arms having
a second end that is configured (i) to deflect radially away
from the elongate flexible member when unrestrained and
(ii) to hold a proximal portion of the self-expanding device
along the elongate flexible member in a position distal to the
arms when (a) the self-expanding device and the arms are
positioned within the lumen of the sheath and (b) the arms
are positioned between the inner wall of the sheath and the
self-expanding device, wherein in a collapsed state, the
proximal portion of the self-expanding device is held by the
arms and a distal portion of the self-expanding device is
positioned within an interior portion of the protective coil,
wherein movement of the arms distally beyond a distal end
of the sheath causes the proximal and distal portions of the
stent to become unrestrained.
(App. Br. 15 (emphasis added).)
2
Appeal2017-007058
Application 13/550, 137
11. A system for delivering a self-expanding stent, the system
compnsmg:
a sheath;
a self-expanding stent;
an assembly comprising an elongate flexible member, a
plurality of arms attached to the elongate flexible member at
a first end, and a protective coil coupled to the elongate
flexible member distal of the arms, the arms having a second
end that is (i) compressed inwardly toward the elongate
flexible member by the sheath to engage the stent when the
arms are in a constrained configuration, and (ii) spaced apart
from the elongate flexible member by a distance greater than
a width of the sheath when the arms are in an open
configuration, the arms being biased toward the open
configuration, wherein in the constrained configuration, a
proximal portion of the self-expanding stent is held by the
arms and a distal portion of the self-expanding stent is
positioned within an interior portion of the protective coil,
wherein movement of the arms to the open configuration
causes the proximal and distal portions of the stent to
become unrestrained.
(Id. at 16-17 (emphasis added).)
16. A system for delivering a self-expanding stent through a
catheter having a lumen, the system comprising:
a self-expanding stent;
an assembly comprising an elongate flexible member, a
plurality of arms attached to the elongate flexible member at
a first end, and a protective coil coupled to the elongate
flexible member distal of the arms, the arms having second
ends that are (i) compressed inwardly toward the elongate
flexible member by the catheter to hold the stent when the
arms are in a constrained configuration, and (ii) spaced apart
from an opposing second end by a distance greater than a
width of the lumen when the arms are in an open
configuration, the arms being biased toward the open
configuration, wherein in the constrained configuration, a
3
Appeal2017-007058
Application 13/550, 137
proximal portion of the self-expanding stent is held by the
arms and a distal portion of the self-expanding stent is
positioned within an interior portion of the protective coil,
wherein movement of the arms to the open configuration
causes the proximal and distal portions of the stent to
become unrestrained.
(Id. at 17-18 (emphasis added).)
The claims stand rejected as follows:
Claims 1--4, 9-13, 15-18, and 20-26 stand rejected under 35 U.S.C.
§ I03(a) as unpatentable over the combination of Hijlkema2 and Lorentzen
Cornelius. 3
Claims 7 and 8 stand rejected under 35 U.S.C. § I03(a) as
unpatentable over the combination of Hijlkema, Lorentzen Cornelius, and
Hebert. 4
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Hijlkema "relates generally to endoluminal grafts or 'stents' and,
more specifically, to stent delivery systems or 'introducers'" (Hijlkema
1:13-15).
2 Hijlkema et al., US 6,858,034 Bl, issued Feb. 22, 2005.
3 Lorentzen Cornelius et al., US 6,068,634, issued May 30, 2000.
4 Hebert et al., US 2003/0163156 Al, published Aug. 28, 2003.
4
Appeal2017-007058
Application 13/550, 137
FF 2. Hijlkema's Figure 3 is reproduced below:
44' 10·
/
42'
31 44
'FIG. 3
23
22
Hijlkema's "FIG. 3 is a longitudinal section schematic illustration of a
portion of an exemplary stent delivery system [10'] of ... [Hijlkema's]
invention, showing ... [a] stent [ 14] in a compressed state cradled in the
docking section pockets [ 40, 40 '] of both ... [a] catheter tip [20 '] and ... [a]
pusher [16']" (Hijlkema 4:27-31 ( emphasis removed); see id. at 4:55 - 5: 1 ).
FF 3. Hijlkema's figure 4 is reproduced below:
14
FIG .. 4
22
I
40
Hijlkema's "FIG. 4 is a longitudinal section schematic illustration of the
pusher [16'] of FIG. 3 shown in a deployed state after retraction of the outer
sheath [12]" (Hijlkema 4:32-34 (emphasis removed); see id. at 4:55-5:1
( emphasis removed)).
FF 4. Hijlkema discloses that"[ w ]hen sheath 12 is retracted beyond end
rim 44 of docking section 42, rim 44 springs open into an outwardly flared
5
Appeal2017-007058
Application 13/550, 137
configuration and releases proximal end 30 of stent 14" (Hijlkema 6:4--7
( emphasis removed)).
FF 5. Lorentzen Cornelius relates to an "apparatus suitable for delivery of
stents to body cavities" (Lorentzen Cornelius 1 :64--65).
FF 6. Lorentzen Cornelius's Figure 3 is reproduced below:
F'ig. 3
Lorentzen Cornelius' FIG. 3 illustrates "a view, in longitudinal section, of
the distal end portion of a balloon catheter [ 1 OJ having a stent [20] fixed to
the catheter by being crimped thereto over the balloon, the ends of the stent
being held" in place by sleeves 22 and 24 (Lorentzen Cornelius 3 :22-26; id.
at 11. 29-30; see id. at 5:24).
FF 7. Lorentzen Cornelius discloses that "[ s ]tent 20 is released from
sleeves 22 and 24 upon expansion of [the] balloon [] by pulling out of the
sleeves and the bunching back of the sleeves" (Lorentzen Cornelius 4:63-67
(emphasis removed)).
6
Appeal2017-007058
Application 13/550, 137
FF 8. Lorentzen Cornelius's Figure 5 is reproduced below:
~F'ig. 5
Lorentzen Cornelius's Fig. 5 illustrates an alternative "embodiment of ...
[Lorentzen Cornelius's] invention used to hold the ends of the stent"
(Lorentzen Cornelius 3:34--35).
FF 9. Lorentzen Cornelius discloses that "sleeves 22 and 24 ... may take
the form of spiral coils," wherein, as with the sleeves, the spiral coils 22b
(not illustrated in Lorentzen Cornelius's Fig. 5 and 24b) separate from the
stent upon balloon expansion (Lorentzen Cornelius 5:24--35 (emphasis
removed)).
FF 10. Examiner finds that the combination of "Hij lkema ... [and]
Lorentzen Cornelius does not disclose a guidewire with a flexible atraumatic
tip or with sections having different diameters" and relies on Hebert to make
up for this deficiency (Ans. 5---6).
ANALYSIS
The combination of Hijlkema and Lorentzen Cornelius:
Based on the combination of Hijlkema and Lorentzen Cornelius,
Examiner concludes that, at the time Appellants' invention was made, it
would have been prima facie obvious "to modify the device of Hijlkema by
providing a protective coil coupled to the elongate member distal of the
arms, as taught by Lorentzen Cornelius, in order to hold the stent in place
before delivery" (Ans. 3--4). We are not persuaded.
7
Appeal2017-007058
Application 13/550, 137
As Appellants explain:
Hijlkema's system restrains the stent at the proximal end with
no distal restraint once the stent exits the sheath. . . . Lorentzen
Cornelius teaches restraining the distal end of a stent with rings
or coils on a catheter shaft, and then expanding a balloon within
the stent to release the distal end from the rings or coils ....
[Thus,] even if Hijlkema were modified to have the distal
restraining feature taught by Lorentzen Cornelius, which the
Appellant[ s do] not concede is proper, the resulting device
would have Hijlkema's end rim for releasing the proximal end
of the stent and Lorentzen Cornelius' balloon/rings for
releasing the distal end of the stent. Given these elements of
the cited references, it follows that movement of Hijlkema's
end rim distally beyond a distal end of the sheath would cause
only the proximal portion of the stent to become unrestrained
while the distal portion of the stent would remain constrained
because the distal portion of the stent would be released only by
expansion of the balloon used in Lorentzen Cornelius. . . . As a
result, [Appellants' independent] claim 1 is patentable over the
cited combination of references because [ the cited references]
do not disclose a system wherein "movement of the arms
distally beyond a distal end of the sheath causes the proximal
and distal portions of the stent to become unrestrained."
[Further, Appellants' only other independent claims,]
[ c ]laims 11 and 16 are ... [ similarly not obvious] over the
combination of Hijlkema and Lorentzen Cornelius because they
have features similar to those explained above with respect to
[Appellants' independent] claim 1.
(App. Br. 9--10.) We agree. For the foregoing reasons, we are not
persuaded by Examiners' assertion that "substituting the coil 24b of
Lorentzen Cornelius into the device of Hijlkema would be met with
expected results, and the device would behave in a similar manner to which
the Hijlkema device operates as is" (Ans. 7; see id. at 6-8; cf Reply Br.
1--4).
8
Appeal2017-007058
Application 13/550, 137
The combination of Hijlkema, Lorentzen Cornelius, and Hebert:
Based on the combination of Hijlkema, Lorentzen Cornelius, and
Hebert, Examiner concludes that, at the time Appellants' invention was
made, it would have been prima facie obvious "to modify the device of
Hijlkema in view of Lorentzen Cornelius by providing a guidewire with a
flexible atraumatic tip or with sections having different diameters, as taught
by Herbert, in order to safely aid in guidewire advancement through the
vasculature" (Ans. 5---6). Examiner, however, failed to establish that Herbert
makes up for the deficiency in the combination of Hijlkema and Lorentzen
Cornelius discussed above.
CONCLUSION
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness.
The rejection of claims 1--4, 9--13, 15-18, and 20-26 under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Hijlkema and Lorentzen
Cornelius is reversed.
The rejection of claims 7 and 8 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Hijlkema, Lorentzen Cornelius, and
Hebert is reversed.
REVERSED
9