Ex Parte Leopold et al

Patent Trial and Appeal Board

Feb 28, 2018

11435303 (P.T.A.B. Feb. 28, 2018)

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.
11/435,303 05/16/2006 Eric Leopold MIC5017USCNT1 4411
27777 7590 03/02/2018
JOSEPH F. SHIRTZ
JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK, NJ 08933-7003
EXAMINER
DAVID, SHAUN L
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
03/02/2018 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):
j nju spatent @ coru s .j nj. com
lhowd@its.jnj.com
pair_jnj @ firsttofile.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ERIC LEOPOLD and BRUCE McEVERS
Appeal 2017-003669
Application 11/435,3031
Technology Center 3700
Before ERIC B. GRIMES, KRISTI L. R. SAWERT, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
SAWERT, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) from the rejection of
claims 16, 17, and 19-29 for obviousness. We have jurisdiction under 35
U.S.C. § 6(b).
We reverse.
1 Appellants identify DePuy Synthes Products, Inc., which is an
affiliate of Johnson & Johnson, as the real party in interest. Br. 1.
Appeal 2017-003669
Application 11/435,303
STATEMENT OF THE CASE
Claims 16, 17, and 19-29 are on appeal. Claims 16, 17, 20, 22-25,
27, and 29 stand rejected as unpatentable under 35 U.S.C. § 103(a) for
obviousness over Barry2 in view of Nool.3 Final Act. 5-14. Claims 19 and
26 stand rejected as unpatentable under 35 U.S.C. § 103(a) for obviousness
over Barry in view of Nool, and further in view of Nordstrom.4 Id. at 14.
Claims 21 and 28 stand rejected as unpatentable under 35 U.S.C. § 103(a)
for obviousness over Barry in view of Nool, and further in view of Heidner.5
Id. at 15.
Claim 16 is representative of the claimed subject matter:
16. A sheath in combination with a detachable
vasoocclusive device, comprising:
a detachable vasoocclusive device including an assembly
of a flexible pusher member and a detachable embolic coil, said
flexible pusher member being formed of a material for
conducting energy, and a distal segment of the flexible pusher
member including a tubular collar of shape memory material
configured to retain said detachable embolic coil and to release
said detachable embolic coil responsive to energy conducted
through said flexible pusher member;
a hollow, elongated tubular member having a lower wall,
an upper wall opposing said lower wall, opposing side walls,
and a longitudinal interior channel; and
2 David C. Barry & Donald K. Jones, U.S. Patent No. 6,277,125 B1
(Aug. 21, 2001) (“Barry”).
3 Jeffrey A. Nool et al., U.S. Patent Publication No. 2002/0072712 A1
(Jun. 13, 2002) (“Nool”).
4 Jon W. Nordstrom & James P. Culhane., U.S. Patent No. 6,033,388
(Mar. 7, 2000) (“Nordstrom”).
5 Matthew C. Heidner & Thomas J. Holman, U.S. Patent Publication
No. 2003/0149465 Al (Aug. 7, 2003) (“Heidner”).
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Application 11/435,303
a longitudinal slot formed in the upper wall of said
hollow, elongated tubular member and extending a first portion
of a length of said hollow, elongated tubular member leaving a
second portion of the length of said hollow, elongated tubular
member with no slot, the slot having opposing sides with inner
side surfaces extending through the upper wall of said hollow,
elongated tubular member leading to the interior channel, said
opposing side walls of said hollow, elongated tubular member
being configured to flex outwardly to permit said detachable
embolic coil, said tubular collar, and a portion of said flexible
pusher member to be inserted in said longitudinal interior
channel of said hollow, elongated tubular member through said
longitudinal slot by a sliding pressure along said portion of said
flexible pusher member, said detachable embolic coil and said
tubular collar, and to be removed from said longitudinal interior
channel of said hollow, elongated tubular member through said
longitudinal slot by pulling said first portion of the length of
said hollow, elongated tubular member off of said tubular
collar, said detachable embolic coil and said portion of said
flexible pusher member until said second portion of the length
of said hollow, elongated tubular member with no slot is
reached, said tubular member being attached to a segment of
the flexible pusher member, with the sheath being able to be
pulled off along the slot of the tubular member until the
segment of the second portion of the tubular member without a
slot is reached.
Br. 9-10 (emphasis added to claim limitation at issue).
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Application 11/435,303
DISCUSSION
We have reviewed Appellants’ arguments in the Brief, the Examiner’s
Final Office Action, and the Examiner’s Answer to the Appellants’
arguments. Upon review of the record, we find that the Examiner did not
establish, by a preponderance of the evidence, that the claimed invention
would have been obvious over the combined prior art references. For this
reason, we reverse the rejection of the claims 16, 17, and 19-29 under
35U.S.C. § 103.
The Claimed Invention
The claimed invention is directed to a reloadable sheath for a
therapeutic vasoocclusive device. Spec. 4. The sheath “permit[s] reuse of
the vasoocclusive embolic coil assembly during a clinical procedure” and,
thus, “minimize[s] the loss of an otherwise acceptable vasoocclusive
embolic coil product.” Id. at 2. According to the Specification, the
vasoocclusive device includes “a flexible pusher member and an embolic
coil.” Id. The sheath is “formed of a hollow, elongated tubular member”
with “a longitudinal interior channel, and a longitudinal slot” that “extend[s]
the length, or majority of the length, of [the] elongated tubular member.” Id.
at 2-3.
Figure 1, reproduced below, shows one embodiment of the reloadable
sheath 10. Id. (Fig. 1).
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Application 11/435,303
FIG. 1
Figure 1 is a perspective view of a first embodiment. Spec. 4.
The vasoocclusive device 12 may be inserted into the sheath by
flexing apart the opposing side walls 28 and 30 of the tubular member 22,
and pushing the vasoocclusive device through the slot 34 and into the
interior channel 32 of the tubular member. Id. at 5-6. In this embodiment,
“the sheath is fully removable from the flexible pusher member.” Id. at 6.
Figure 4, below, illustrates a “variation” of the embodiment shown in
Figure 1, where the “vasoocclusive device [is] permanently attached to an
end of the reloadable sheath.” Id. at 4. As noted above, the vasoocclusive
device 12 comprises the flexible pusher member 14 and the embolic coil 16.
Id.
Figure 4 is a longitudinal sectional view of a third embodiment,
showing the vasoocclusive device substantially unloaded from
the sheath. Spec. 4.
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Application 11/435,303
The Specification explains that, in this embodiment, a portion 40 of
the flexible pusher member 14 remains attached to the sheath 10 “to
facilitate initiation of loading the flexible pusher member into the sheath.”
Id. at 7. Thus, in practice, “[t]he sheath can be pulled off along the slot until
the segment of the sheath without a slot is reached.” Id. “The sheath can
then be looped and left attached to the end of the flexible pusher member
while the flexible pusher member is loaded into a microcatheter (not
shown).” Id. Because the flexible pusher member is attached to the sheath
in this embodiment, that portion of the elongated tubular member 22 has no
slot. See id. at 3 (explaining that “the elongated tubular member consisting
of a length with no slot [is] attached to a segment of the flexible pusher
member to facilitate initiation of loading of the flexible pusher member and
embolic coil into the sheath”).
The Prior Art
Barry discloses a sheath 12 with a detachable vasoocclusive device
20. Barry, Fig. 3, 3:55—4:2. The vasoocclusive device includes a flexible
pusher member 36 and a detachable embolic coil 20. Id. The pusher
member is disposed within an elongated tubular member 22, and the tubular
member is “slideably received by” catheter 12. Barry, 3:59-61.
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Application 11/435,303
Figure 3 is an enlarged partially sectional view of the Barry’s
sheath. Barry, 3:40^14.
Nool also discloses a sheath with a detachable vasoocclusive device.
Nool, Abstract. As shown in Figure 46, below, the sheath 700 comprises a
longitudinal slot 712 “along the proximal end portion of the . . . sheath.”
Nool ^ 159. The projections 704, 706 allow the user to “easily open and
close the longitudinal slot” for loading the detachable vasoocclusive device.
Id. THf 159, 161.
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Application 11/435,303
Figure 46 is a perspective view of an embodiment of Nool’s
device where the proximal end portion of the sheath is formed
with a longitudinal slot. Nool ^ 94.
The Rejection
The Examiner rejected representative claim 16 for obviousness over
Barry in view of Nool. Final Act. 5-10. The Examiner found that “Barry
discloses a sheath in combination with a detachable vasoocclusive device,
and Nool discloses a sheath in combination with a detachable vasoocclusive
device,” and therefore:
It would have been obvious to one having ordinary skill in the art
at the time the invention was made, as a matter of simple
substitution of one known element for another to obtain the
predictable result of having a sheath being configured to
removably enclose a vascular implant device, to substitute the
sheath of Barry with the sheath of Nool, in that Nool’s sheath
would still protect the device while allowing the device to be
deployed within the body.
Id. at 8-9 (citation omitted).
The Examiner also found that, “in making the substitution of sheaths,
Nool’s sheath’s tubular member would be attached to a segment of the
flexible pusher member of Barry, particularly when the sheath is opened up
to insert or remove the device.” Id. (citing Nool ^ 161). In doing so, the
Examiner referred to the dictionary definition of “attached” as “connected or
joined to something,” Ans. 5-6, and reasoned that:
Looking at Figure 1 of Barry, pusher member (36), which as
shown in Fig. 2 is “connected to or joined to” tubular member
(22), is also “connected to or joined to” sheath (12), since pusher
member (36) is disposed within tubular member (22) and tubular
member (22) is “slideably received” within sheath (12).
Essentially, all the structure shown in Fig. 1 of Barry are
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Application 11/435,303
“connected to or joined to” each other, and therefore are
“attached” to each other.
Id. at 5. The Examiner further reasoned that the term “attached” “says
nothing about direct or structural attachment, i.e., where one element is
‘connected or joined to’ another element via a fixation structure or where the
elements directly engage each other via friction fit or some other connective
mechanism.” Id. (emphases omitted).
The Examiner also found that, once Barry’s sheath was replaced with
Nool’s, the resulting combination would be capable of “be[ing] pulled off
along the slot of the tubular member until the segment of the second portion
of the tubular member without a slot is reached.” Final Act. 9. The
Examiner stated that this requirement is “merely [a] functional limitation[],
and the combination device of Barry and Nool is capable of performing
th[is] limitation[] as claimed.” Id. at 9-10. In particular, the Examiner
found that Nool’s sheath has a slot that does not extend the full length of the
tubular member and that separates for inserting a vasoocclusive device, and
therefore “the construction of Nool’s sheath would allow a user to pull off
the sheath along the slot until the segment of the second portion without a
slot is reached.” Ans. 8.
Discussion
The dispositive issue in this case, as Appellants point out, is whether
the prior art teaches or suggests that the “tubular member [is] attached to a
segment of the flexible pusher member,” as recited in claim 16. Br. 6. We
agree with Appellants that the prior art does not teach or suggest a tubular
member “attached” to a segment of the flexible pusher member.
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During examination, claim terms are given their “broadest reasonable
interpretation” consistent with the specification as it would be understood by
one of ordinary skill in the art. In re Am. Acad. ofSci. Tech Ctr., 367 F.3d
1359, 1364 (Fed. Cir. 2004). “While the Board must give the terms their
broadest reasonable construction, the construction cannot be divorced from
the specification and the record evidence.” In reNTP, Inc., 654 F.3d 1279,
1288 (Fed. Cir. 2011).
As recited in claim 1, the elongated tubular member is “attached to a
segment of the flexible pusher member” so that the sheath may “be pulled
off along the slot of the tubular member until the segment of the second
portion of the tubular member without a slot is reached.” Id. at 9. Put
differently, because the longitudinal slot of the elongated tubular member
does not extend the full length of the tubular member, the sheath may be
pulled off the tubular member until it reaches the portion of the sheath where
the elongated tubular member is attached to the flexible pusher member. See
id. (“a longitudinal slot formed in the . . . elongated tubular member and
extending a first portion of a length of said . . . elongated tubular member
leaving a second portion of the length of said . . . elongated tubular member
with no slot”).
The Specification refers to this embodiment of the invention as a
“variation” where “the elongated tubular member consists] of a length with
no slot.” Spec. 3. As shown in Figure 4, reproduced again below, that
portion of the elongated tubular member is attached to a segment 40 of the
flexible pusher member. Spec. 7; Fig. 4.
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Application 11/435,303
As explained above, the Examiner interpreted “attached” to include
connection via side-by-side arrangement and/or frictional fit. Ans. 5-6. But
the Specification explains that, in this claimed variation, the sheath is
“formed in combination with the vasoocclusive device.” Spec. 3 (emphasis
added); see also id. at 4 (describing “a vasoocclusive device permanently
attached to an end of the reloadable sheath” (emphasis added)). Thus, we
conclude that the Examiner’s interpretation of “attached” is unreasonably
broad in light of the Specification, because the Specification and Figure 4
make clear that a physical attachment connects the elongated tubular
member to segment 40 of the flexible pusher member. Spec. 7; Fig. 4.
Moreover, we disagree with the Examiner that the combination of
Noofs sheath with Barry’s device would allow the sheath to “be pulled off
along the slot of the tubular member until the segment of the second portion
of the tubular member without a slot is reached.” Final Act. 8-9. If Nool’s
sheath were only attached to Barry’s vasoocclusive device via frictional fit
or side-by-side positioning, no physical attachment would prevent the sheath
from sliding off the vasoocclusive device. Indeed, the Specification
contrasts the “variation” now claimed with the first embodiment, wherein
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“the sheath if fully removable from the flexible pusher member.” Spec. 6.
We also note that Nool’s sheath could not perform the function of
“facilitating] initiation of loading of the flexible pusher member into the
sheath,” as also described in the Specification. Id. at 7.
In summary, we find that the Examiner’s rejection is based on an
unreasonably broad interpretation of “attached” in light of the Specification.
Thus, we reverse this rejection.
The remaining rejections
Because the remaining rejections rely on the combination of Barry
and Nool, we reverse the rejection of 19 and 26 over Barry in view of Nool,
and further in view of Nordstrom, and of claims 21 and 28 over Barry in
view of Nool, and further in view of Heidner, for the same reasons
articulated above.
SUMMARY
We reverse the rejection of claims 16, 17, and 19-29 under 35 U.S.C.
§ 103.
REVERSED
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