Ex Parte Eder et al

Patent Trial and Appeal Board

Sep 27, 2012

09957980 (P.T.A.B. Sep. 27, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________

Ex parte JOSEPH C. EDER, STANLEY W. OLSON, JR.,
PAUL C. SLAIKEU, and ROBERT M. ABRAMS
____________________

Appeal 2011-012692
Application 09/957,980
Technology Center 3700
____________________

Before EDWARD A. BROWN, MICHELLE R. OSINSKI, and
SCOTT E. KAMHOLZ, Administrative Patent Judges.

BROWN, Administrative Patent Judge.

DECISION ON APPEAL
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STATEMENT OF THE CASE
Appellants appeal under 35 U.S.C. § 134(a) from the Examiner's
decision rejecting claims 1-3, 10-13, 20-24, 26-29, 31, and 32. (App. Br. 1).
Claims 4-9, 14-19, 25, and 30 have been canceled. (Id.). We have
jurisdiction over this appeal under 35 U.S.C. § 6(b).
We affirm.
THE CLAIMED SUBJECT MATTER
The claimed subject matter is directed to a vaso-occlusive device.
Claim 1, reproduced below, is illustrative.
1. A vaso-occlusive device comprising:
a biocompatible member having a coil
configuration, said coil configuration having
a positive pitch between each turn, said
member having an outer surface;
a rigid, blunt tip attached to at least
one end of said member, said blunt tip
having a cross-sectional dimension
extending completely across the diameter of
said coil configuration, said rigid, blunt tip
having an outer surface;
an inner bioactive coating on
substantially the entire outer surface of said
member, said inner bioactive coating on
substantially the entire outer surface of said
rigid, blunt tip, and said inner bioactive
coating permanently bonded to both said
member and said rigid, blunt tip; and
an outer coating covering
substantially the entire area of said inner
coating prior to elution of the outer coating,
said outer coating being dissolvable and
comprising a hydrophilic agent that affects
the solubility of said outer coating.

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THE REJECTION
Claims 1-3, 10-13, 20-24, 26-29, 31, and 32 under 35 stand rejected
under U.S.C. § 103(a) as unpatentable over Kupiecki (US 5,669,931; issued
Sep. 23, 1997), Neuss (US 5,536,274; issued Jul. 16, 1996), and Ritchart
(US 4,994,069; issued Feb. 19, 1991).
ANALYSIS
The Examiner found Kupiecki discloses a vaso-occlusive device
comprising, inter alia, a biocompatiable support member, and an inner
bioactive coating comprising a thrombogenic material or a material that
causes a tissue reaction, on the entire outer surface of the member. (Ans. 4).
The Examiner found Kupiecki does not disclose that the thrombogenic
material is permanently bonded to the member. (Ans. 5). The Examiner
found Neuss teaches this limitation, and concluded that it would have been
obvious to one of ordinary skill in the art to modify the inner bioactive
coating of Kupiecki's device so that it is permanently bonded to the member
to "ensure a continuous thrombotic effect where the device is implanted."
(Ans. 5). The Examiner also found Kupiecki does not disclose "an outer
coating being dissolvable and comprising a hydrophilic agent that affects the
solubility of the outer coating." (Ans. 5). The Examiner found Ritchart
discloses a flexible vaso-occlusive device including an outer coating that is
dissolvable and comprises a hydrophilic agent that affects the solubility and
time for release of the outer coating. (Ans. 5) (citing Ritchart col. 5, l. 62 –
col. 6, l. 5, Figs. 4A, 4B). The Examiner concluded that it would have been
obvious to one of ordinary skill in the art, in view of Ritchart, to apply an
outer coating as claimed onto Kupiecki's device, stating "[s]uch a coating
would rigidify the device for its deployment through blood vessels and cure
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the deficiency of Kupiecki et al. in view of Neuss, where [Kupiecki] et al.
disclose, in col. 7, lines 7-20, that their device is 'flexible' and exhibits 'little
column strength' (like the device of Ritchart et al.)." (Ans. 5-6).
We have considered Appellants' contentions set forth in their Briefs,
but do not find them persuasive for the reasons discussed infra. Appellants
contend that Kupiecki describes Ritchart's device as unsatisfactory. (App.
Br. 3-4) (citing Kupiecki col. 1, l. 65 – col. 2, l. 16; col. 2, ll. 42-44).
Appellants contend that Kupiecki improves upon Ritchart's device and
describes an extremely flexible coil. (App. Br. 4-5). Appellants contend
that Kupiecki favors hydraulic delivery of the device because of the extreme
flexibility of the coil. (App. Br. 5). Appellants also contend that one of
ordinary skill in the art would not look to Neuss and Ritchart to cure
Kupiecki's deficiencies because Neuss and Ritchart are directed to coils that
are adapted to be deliverable by pushing into a vessel lumen, but not to
extremely flexible coils that are hydraulically delivered. (App. Br. 5).
Appellants further contend that a person skilled in the art would have
no reason to coat Kupiecki's coil with Ritchart's rigidifying substance, when
Kupiecki is focused on maintaining extremely flexible coils even when they
are coated with a drug material and/or a thrombogenic material. (App. Br.
5) (citing Kupiecki, col. 7, ll. 7-9.) Appellants contend that Ritchart's rigid,
water-soluble material "acts to hold a flexible, coiled wire in its linear
condition until the material is contacted with aqueous medium, either in the
delivery catheter or at the vessel site." (App. Br. 5) (citing Ritchart, col. 3, ll.
14-20), and that this modification would render Kupiecki's device
unsatisfactory for its intended purpose (App. Br. 6). Appellants' contentions
are not persuasive.
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In response, the Examiner disagreed that the modification of
Kupiecki's device to include Ritchart's rigid coating would render the device
inoperable for its intended purpose. (Ans. 6-7). The Examiner found
Kupiecki discloses that hydraulic delivery is only a preferred delivery means
for the device. (Ans. 7) (citing Kupiecki col. 4, ll. 11-14, which describes:
"Referring to the drawings . . . occlusive implants or devices and preferred
modes for their delivery are shown in accordance with the principles of the
present invention.") The Examiner also found Kupiecki does not exclude
catheterization as a means for device delivery, and its invention is is also
deliverable hydraulically. (Ans. 7). While Kupiecki discloses that "[the
occlusive implants] preferably are hydraulically delivered to the desired site
as opposed to being mechanically pushed[]" (see Kupiecki, col. 7, ll. 20-21),
Kupiecki discloses mechanical delivery as well. Appellants have not
identified any disclosure in Kupiecki that its implants could not be
mechanically delivered to a desired body site.
The Examiner also stated:
Ritchart provides the teaching of a flexible, vaso-
occlusive device having low column strength
(comparable to Kupiecki's device), where the
device is rigidified with an outer coating and is
delivered to a vasculature site reachable by
catheterization. The outer coating eventually
dissolves in the body and allows the device, like
Kupiecki's device, to "conform to blood vessels
having a complex geometry ... exert little radial
force ... and minimize the risk of trauma or even
perforation to the blood vessels" (as the Appellant
stated in arguments of August 2, 2010). A
rigidifying coating for the flexible coil, as taught
by Ritchart, advantageously allows Kupiecki's
device to be delivered to a patient's body, where
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catheterization is the desired or likely means of
delivery. In short, Kupiecki's device, as modified
by Ritchart, would remain satisfactory for it
intended purpose.
(Ans. 7-8) (emphasis added). We agree with the Examiner.
Kupiecki describes Ritchart's vaso-occlusive devices, as follows:
"Ritchart et al., shows a flexible, preferably coiled, wire for use in small
vessel vaso-occlusion. Unlike vaso-occlusive coils previously, Ritchart et
al. teaches a coil which is fairly soft and is delivered to the site using a
pusher within a catheter lumen." (See Kupiecki, col. 2, ll. 3-7) (emphasis
added). Ritchart applies a rigid coating to the flexible wires to hold them in
a linear condition until the material is contacted with an aqueous medium,
which can occur at the vessel site. (See Ritchart, col. 3, ll. 14-17). While
Appellants contend that "[t]here is no indication that Kupiecki's coils are
even amenable to delivery using a pusher wire, or a guidewire" (App. Br. 7),
Appellants also acknowledge that "Kupiecki does not explicitly deny
pushing a coil with an insertion guidewire or with a pusher wire into a vessel
lumen" (Reply Br. 2). Appellants have provided no persuasive argument or
evidence as to why Kupiecki's coils, as coated with Ritchart's rigid coating,
could not be delivered mechanically to a body site. Appellants also state
that "Kupiecki's delivery method directly relates to his extremely flexible
coil, which fulfills the need of 'a liquid coil type fluid delivery embolism
forming device.'" (Reply Br. 2). However, Appellants also have provided
no persuasive argument or evidence as to why Kupiecki's coils, as coated
with Ritchart's rigid coating, could not alternatively be delivered
hydraulically. One of ordinary skill in the art would appreciate that
providing Ritchart's rigid coating on Kupiecki's coils would be desirable for
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delivery purposes, in that this modification would not prevent the coils from
being delivered hydraulically, and it would increase the rigidity of the coils
for mechanical delivery.
In addition, Ritchart discloses that its water-soluble, rigid coatings are
effective to hold the wire in its linear condition until contacted with an
aqueous medium at the delivery site. Appellants have provided no
persuasive argument or evidence as to why Kupiecki's coils, as coated with
Ritchart's rigid coating, would be unable to provide their "fluid-like
properties" (Kupiecki, col. 7, l. 11) in vessels to which they have been
delivered, once the rigid coating has dissolved. In KSR, the Supreme Court
stated that "[t]he combination of familiar elements according to known
methods is likely to be obvious when it does no more than yield predictable
results." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-16 (2007). Here,
Appellants have not shown by persuasive argument or evidence that the
combined teachings of Kupiecki, Neuss, and Ritchart would not have
yielded predictable results. Appellants also have not established that this
combination of teachings would have been beyond the level of ordinary skill
in the art. Accordingly, we agree with the Examiner's conclusion of
obviousness. We sustain the rejection of claims 1-3, 10-13, 20-24, 26-29,
31, and 32.
DECISION
The Examiner's decision rejecting claims 1-3, 10-13, 20-24, 26-29, 31,
and 32 is affirmed. No time period for taking any subsequent action in
connection with this appeal may be extended under 37 C.F.R. § 1.136(a).
See 37 C.F.R. § 1.136(a)(1)(iv).
AFFIRMED
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