Ex Parte DIVINO et al

Patent Trials and Appeals Board

Jun 27, 2019

14079587 - (D) (P.T.A.B. Jun. 27, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/079,587
137574 7590
Medtronic
826 Coal Creek Circle
Louisville, CO 80027
11/13/2013
07/01/2019
FIRST NAMED INVENTOR
Vincent DIVINO
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-02819US3 5182
EXAMINER
DORNBUSCH, DIANNE
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
07/01/2019 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 VINCENT DIVINO,
EARL FREDERICK BARDSLEY, RICHARD RHEE,
MADHUR ARUNRAO KADAM, and JULIE KULAK1
Appeal2018-008075
Application 14/079,587
Technology Center 3700
Before JENNIFER D. BAHR, JAMES P. CAL VE, and
GEORGE R. HOSKINS, Administrative Patent Judges.
BAHR, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellant appeals under 35 U.S.C. § 134(a) from the Examiner's
decision rejecting claims 9, 10, 24, and 25.2 We have jurisdiction under
35 U.S.C. § 6(b ).
We AFFIRM.
1 According to the Application Data Sheet submitted November 13, 2013,
Covidien LP (Appellant) is the applicant as provided in 37 C.F.R. § 1.46, but
the Appeal Brief identifies Medtronic plc as the real party in interest.
Appeal Br. 2.
2 All other claims have been canceled or withdrawn from consideration.
Appeal2018-008075
Application 14/079,587
THE CLAIMED SUBJECT MATTER
Claim 9, reproduced below, is illustrative of the claimed subject
matter.
9. A system for treatment of an aneurysm, comprising:
an intrasaccular device comprising[:]
at least three expandable components adapted to
transition from a compressed configuration to an expanded
configuration when deployed into the aneurysm; and
individual segments of filaments interconnecting
the at least three expandable components, the individual
segments of filaments having preset shapes and fixed
lengths that define a preset polygonal shape between
the expandable components when the intrasaccular device
is in an expanded state, wherein[:]
the at least three expandable components can be
advanced as an interconnected unit into the aneurysm, and
when in the expanded state, the at least three
expandable components are spaced relative to each other
at a preset orientation to form the preset polygonal shape
defined by the preset shapes and fixed lengths of the
individual segments of filaments.
THE REJECTION
The Examiner rejected claims 9, 10, 24, and 25 under 35
U.S.C. § 103(a) as unpatentable over Razack (US 2005/0267510 Al,
published Dec. 1, 2005) and Wallace (US 6,322,576 Bl, issued Nov. 27,
2001).
DISCUSSION
The Examiner found that Razack discloses all of the limitations of
claim 1, including at least three expandable components (beads 42) and
individual segments of filaments (strand segments 52), except for the
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individual segments of filaments having "preset shapes and fixed lengths
that define a preset polygonal shape between the expandable components
when the intrasaccular device is in an expanded state." Final Act. 2-4. The
Examiner found that Wallace discloses a well-known intrasaccular device
having a filament/coil that has a preset shape and fixed length that define a
preset polygonal shape when the intrasaccular device is in an expanded state.
Id. at 4 (citing Wallace, Abstract; Figs. 21B-22A; 3:1-5; 4:48-60). The
Examiner also found that Wallace "discloses that the coil can have a variety
of preset shapes and that the complex, in vivo shape is similar to its annealed
memory, making it less likely that the coil will lose its shape over time." Id.
(citing Wallace, Abstract; 3:1-5; 4:48-60; 6:55-60). The Examiner
determined it would have been obvious
Id.
to provide Razack with a polygonal preset shape of the
wires in view of the teachings of Wallace, in order to
provide the device with a stable device which will allow
the invention to fit a variety of aneurysms as well as
making it less likely that the device will lose its shape
over time.
The Examiner clarified that Wallace "is merely used to teach the
polygonal shape while Razack ... does teach the individual segments of
filaments that interconnect the at least three expandable components."
Ans. 3; see also Adv. Act. 2 (dated Jan. 25, 2018).
Appellant argues that "Wallace does not disclose the claimed
'individual segments of filaments' of claim 9" because "Wallace discloses
an occlusive coil made of a continuous wire wound about a mandrel and heat
set in a spiral shape." Appeal Br. 6. Appellant also argues that Wallace
does not "disclose the use of any expandable components with the coil" and,
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thus, "cannot meet the claim 9 requirement that the individual segments of
filaments define a polygonal shape between the expandable components."
Id. Further, Appellant contends that "the polygonal shape of claim 9 cannot
be separated from the individual segments of filaments because the
polygonal shape is defined by the individual segments of filaments." Id. at
7.
Appellant's arguments are unavailing because they attack Wallace
individually, rather than in combination with Razack, as set forth by the
Examiner. Nonobviousness cannot be established by attacking the
references individually when the rejection is predicated upon a combination
of prior art disclosures. See In re Merck & Co., 800 F.2d 1091, 1097 (Fed.
Cir. 1986) (citing In re Keller, 642 F.2d 413,425 (CCPA 1981)). The
combination proposed by the Examiner would retain Razack's individual
segments of filaments (strand segments 52), made of shape memory metal or
polymer, interconnecting beads 42, but would arrange/configure them to
define a preset polygonal shape between the beads when the device is in an
expanded state. See Adv. Act. 2 ( citing Razack ,-J 29 for its disclosure of
shape memory metal or polymer portions interconnecting the beads).
Appellant also argues that the modification proposed by the Examiner
would render Razack's device unsatisfactory for its intended purpose.
Appeal Br. 7. In particular, Appellant points out that "Razack teaches a
'substantially flexible' device so that the device may 'efficiently' and
'quickly' take 'any shape, orientation, volume filling geometry or the like,"'
and "[t]o achieve such flexibility, Razack positions the beads 12 on the
strand 20 'such that the occluding device 10 may be moved to any
appropriate geometry or volume."' Id. ( citing Razack ,-J 39). Further,
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Appellant adds, Razack's "strand configuration 'allow[s] for a substantial
flexibility of the complete occluding device 10 to allow for ease of
implantation and positioning," including "bending and turning as needed
while being delivered to the aneurysm to conform to the interior geometry of
the aneurysm." Id. (citing Razack ,i,i 36, 72, 73; Fig. 11). According to
Appellant, if Razack' s device were modified to have a more rigid strand that
defines a preset polygonal shape between beads 42, as required by claim 9,
the beads would have relative positions in the aneurysm controlled by the
preset shape and, thus, "would not be free to change directions relative to
one another." Id. at 8. Thus, Appellant contends, the modified device
"would not be 'substantially flexible,"' rendering it "unsatisfactory for its
intended purpose of conforming to aneurysms of all shapes and sizes." Id.
In response, the Examiner points out that both Razack and Wallace
"are in the same field, use a shape memory material, are delivered in the
same manner in a straight configuration through a catheter[,] ... and form a
preset shape." Ans. 5; see also Adv. Act. 2 (stating that "Razack discloses
that the interconnected portions can be a shape memory metal or polymer
'for forming a selected structure' ([0029]) hence a selected shape.").
Therefore, the Examiner determines "that a person of ordinary skill in the art
would look into Wallace for a specific shape such as a polygon to be used in
the device of Razack" in order to provide "a stable device which will allow
the invention to fit a variety of aneurysms as well as making it less likely
that the device will lose its shape over time." Ans. 5-6.
Appellant takes issue with the Examiner's finding that Razack
discloses that the interconnecting portions (strand segments 52) can be a
shape memory metal or polymer for forming a selected structure, and hence
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a selected shape. Appeal Br. 9. Appellant characterizes the "discussion of a
shape memory material and 'selected structure'" in paragraph 29 of Razack
as merely referring to "ambiguous 'various portions' of the device," leaving
it "not at all clear that such disclosure also applies to the strand 20 relied
upon by the Examiner for the individual segments of filaments of claim 9."
Id.
Appellant's argument is unsound. First, the Examiner relies on
Razack's strand segments 52, not strand 20, for the individual segments of
filaments of claim 9. See Final Act. 2-3. Further, Razack discloses that
"beads 12 may be interconnected with various portions, such as metallic
portions including those that may be formed from, but not limited to[,]
platinum and gold, or may be interconnected with various shape memory
metals or polymers," including "[a] shape memory polymer [that] may have
a glass transition temperature of below about 25° C[] for forming a selected
structure." Razack ,i 29 (boldface omitted, emphasis added). In other
words, Razack' s discussion of shape memory material for forming a selected
structure is directed explicitly to the portions that interconnect the beads,
and, thus, pertains expressly to strand segments 52.
For the reasons that follow, we do not find that Razack and Wallace
support Appellant's contention that modifying Razack's device by
configuring strand segments 5 2 to have preset shapes and lengths that define
a preset polygonal shape between beads 42 would render the device
insufficiently flexible to satisfy the intended purpose of Razack.
Razack' s invention is intended to be an improvement over the prior
art hydro gel coated platinum micro coils discussed in paragraph 4 of the
background section of Razack. These coated prior art coils have an
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advantage over bare platinum coils in that, by expanding over time, they are
able to embolize a significantly greater portion of the aneurysm lumen,
thereby improving the durability of the treatment and reducing the rate of
recannalization of the aneurysm. Razack ,i 4. However, the hydro gel coated
coils tend to be more rigid than the bare platinum coils, thereby posing a
greater risk of perforating the wall of the aneurysm, which is far weaker than
a normal arterial wall, during deployment. Id. Thus, an objective of
Razack's invention is to provide a device "with the potential to significantly
increase the degree of embolic packing of an aneurysm compared to a bare
platinum coil without increasing the intrinsic rigidity of the embolic device
or decreasing its rigidity compared to a bare platinum coil." Id. ,i 5. Stated
differently, Razack seeks to provide a device that retains the softness of bare
platinum coils while providing the embolic packing advantages of hydro gel.
Id.
Razack accomplishes this objective by providing a plurality of
spherical members (beads) containing expandable hydrogel "interconnected
with a substantially rigid or flexible member over a substantially short
distance to allow for a flexibility of the apparatus for easy positioning of the
apparatus within the aneurysm." Id. ,i 6. By way of example, the beads may
be interconnected with portions formed from platinum or from various shape
memory metals or polymers having a glass transition temperature below
about 25° C for forming a preset structure/shape. Id. ,i 29. Razack discloses
that the device, "according to any appropriate embodiment, may be
substantially flexible such that it may be provided in substantially any shape,
orientation, volume filling geometry or the like. Id. ,i 39. Razack
contemplates that there may be some limitations to the range of aneurysms
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for which any particular device according to Razack' s invention is suitable.
See id. ,i 66 (stating that "the occluding device 120 may be provided for
selected sizes of aneurysms that may be substantially obstructed with a
single occluding unit." (boldface omitted)). Razack's device "may be
provided to the aneurysm ... through a selected catheter or microcatheter."
Id. iJ 70.
Wallace, likewise, seeks to provide an implantable vaso-occlusive
device that improves upon the embolic packing ability of a linear helical
vaso-occlusive coil, such as a platinum coil. Wallace 1:11-2:54; 4:49-60;
5:36-40. In particular, Wallace's devices have shapes that "provide an
improved blood flow baffle design at the neck and dome of the aneurysm,
thereby providing extra protection for aneurysms which because of their
fragility cannot be densely packed with other coil types" and that provide
stability to the coils that "reduces the incidence of coil compaction, a
phenomen[ on] that may occur over time when coils move back to the shape
of their first configuration." Id. 4:49-59. In addition, the stable coils of
Wallace's invention "can fit a variety of aneurysms." Id. 4:59-60. Wallace
discloses nitinol, a superelastic alloy having shape memory properties, as a
suitable material for the coil wire, and points out that such a wire may be
significantly smaller in diameter than platinum, which is relatively more
ductile. Id. 5:36-40. Wallace also disclose that the coil has an in vivo shape
that is similar to its annealed memory, making it less likely to lose its shape
over time. Id. 6:59-61.
In other words, Wallace teaches providing a device that has a preset
shape when it is in its relaxed state within the aneurysm, thereby making it
less likely that the device will lose its shape over time. Further, like
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Razack's device, Wallace's device is delivered to the aneurysm through a
catheter. Id. 9:48-50. As the device "exits the distal end of the catheter ...
it 'self-winds' to begin forming the complex structure." Id. 9:50-53.
Because of the configuration of Wallace's device, as the device exits the
catheter and self-winds, it fills the space of the aneurysm by passage through
a central region of the aneurysm, rather than along its wall. Id. 9:54-62.
In summary, based on the findings above, both Razack's device and
Wallace's device are intended for the same purpose (to occlude aneurysms),
seek to improve upon prior art platinum coils by providing better aneurysm
filling capability, are sufficiently flexible to be delivered to the aneurysm
through a catheter and then self-wind to fill the space within the aneurysm,
may provide this flexibility using strands or coils of shape memory material,
and can fit a variety of different aneurysms. Thus, modifying Razack's
device by providing strand segments 52 having preset shapes and fixed
lengths that define a preset polygonal shape, as taught by Wallace, between
beads 42 when the device is in an expanded state within the aneurysm would
not render Razack' s device unsatisfactory for its intended purpose.
For the above reasons, Appellant does not apprise us of error in the
rejection of claim 9.
In contesting the rejection of claim 10, Appellant asserts that Wallace
and Razack "fail to disclose or suggest 'wherein the at least three
expandable components comprise at least four expandable components."'
Appeal Br. 9. This argument is unsound. The Examiner found, correctly,
that Razack's device comprises "at least four expandable components."
Final Act. 3 ( citing Razack, Figs. 2, 3, 10, 11 ). Thus, Appellant does not
apprise us of error in the rejection of claim 10.
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In contesting the rejection of claim 24, Appellant asserts that
"Wallace and Razack fail to disclose or suggest 'wherein the at least three
expandable components are defined by a foam having a specific porosity."'
Appeal Br. 9-10. This argument is unsound. Razack discloses that the
beads may be porous and, for example, may be provided with a coating
including "microcellular foams." Razack ,-J,-J 6, 31; see Final Act. 3 (finding
that Razack's expandable components comprise foam having a specific
porosity ( citing Razack ,-J 6)). Thus, Appellant does not apprise us of error in
the rejection of claim 24.
In contesting the rejection of claim 25, Appellant argues that Razack
and Wallace fail to disclose or suggest the additional limitations of claim 25
because the modified device would not provide the requisite flexibility to
permit "Razack's device to 'efficiently' and 'quickly' take 'any shape,
orientation, volume filling geometry or the like,"' thereby rendering
Razack's device unsatisfactory for its intended purpose. Appeal Br. 10.
This line of argument is unavailing for the reasons set forth above in
addressing the rejection of claim 9. Thus, Appellant fails to apprise us of
error in the rejection of claim 25.
Accordingly, we sustain the rejection of claims 9, 10, 24, and 25 as
unpatentable over Razack and Wallace.
DECISION
The Examiner's decision rejecting claims 9, 10, 24, and 25 is
AFFIRMED.
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Application 14/079,587
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § l .136(a). See 37 C.F.R.
§ l.136(a)(l )(iv).
AFFIRMED
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