Ex Parte SPECK et al

Patent Trials and Appeals Board

Mar 14, 2019

14255392 - (D) (P.T.A.B. Mar. 14, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/255,392 04/17/2014 Ulrich SPECK
28390 7590 03/18/2019
MEDTRONIC VASCULAR, INC.
IP LEGAL DEPARTMENT
3576 UNOCAL PLACE
SANTA ROSA, CA 95403
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.
C00006001.USC95 9894
EXAMINER
DRAPER, LESLIE A ROYDS
ART UNIT PAPER NUMBER
1629
NOTIFICATION DATE DELIVERY MODE
03/18/2019 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.vasciplegal@medtronic.com
rs.patents.five@medtronic.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ULRICH SPECK and BRUNO SCHELLER
Appeal2018-005200
Application 14/255,392
Technology Center 1600
Before ERIC B. GRIMES, MICHAEL J. FITZPATRICK, and
RYAN H. FLAX, Administrative Patent Judges.
FITZPATRICK, Administrative Patent Judge.
DECISION ON APPEAL
Ulrich Speck and Bruno Scheller ("Appellants") 1 appeal under
35 U.S.C. § 134(a) from the Examiner's final decision rejecting claims 16-
25 and 27--40. We have jurisdiction under 35 U.S.C. § 6(b ).
We affirm.
1 Appellants identify Bayer Intellectual Property GMBH and Medtronic
Vascular, Inc. as real parties in interest. Appeal Br. 2.
Appeal2018-005200
Application 14/255,392
STATEMENT OF THE CASE
The Specification
The Specification explains:
Stenoses of blood vessels are a major cause of morbidity
and mortality. Local stenosis or occlusions of larger vessels up
to ca. 2 mm in diameter can be dilated back to their original
lumen in many instances using inflatable balloon catheters. High
pressures are applied when doing this, which may result in
lacerations of the thickened vascular walls that are squeezed and
displaced into the surrounding tissue. In some of these
operations, tubular perforated metal supports ( stents) are
implanted to keep the vessels open. The vascular walls treated
in this way frequently respond by increased growth in thickness
that is similar to developing a scar within a few weeks and
months. As a result and due to advancing arteriosclerosis, these
vessels may relatively soon become stenosed again (restenosis ).
Restenosis is a severe medical problem that causes high costs.
Spec. 1. Thus, the claimed "invention relates to a preparation for restenosis
prevention and its application to an angiography catheter." Id.
The Rejected Claims
Claims 16-25 and 27--40 are pending and rejected. Final Act. 1.
Claim 16, the sole independent claim, is representative and reproduced
below.
16. A catheter balloon comprising a paclitaxel-
containing layer and a paclitaxel-free layer coated thereon.
Appeal Br. 19 (Claims App.).
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Application 14/255,392
The Appealed Rejections
The following rejections under 35 U.S.C. § I03(a) are before us for
review:
1. claims 16, 27, 37, and 38 over Barry,2 Herdeg, 3 and Charles4
(Final Act. 3--4);
2. claims 17, 24, 25, and 39 over Barry, Herdeg, Charles, and
Berge5 (id. at 6-7);
3. claim 18 over Barry, Herdeg, Charles, Berge, and Abendschein6
(id. at 7-8);
4. claim 19 over Barry, Herdeg, Charles, Berge, and Rosen 7 (id. at
8);
5.
6.
at 8-9);
7.
(id. at 9);
claim 20 over Barry, Herdeg, Charles, Berge, and Ondetti 8 (id.);
claim 21 over Barry, Herdeg, Charles, Berge, and Krause 9 (id.
claims 22 and 23 over Barry, Herdeg, Charles, Berge, and Sax 10
2 WO 99/08729, published Feb. 25, 1999 ("Barry").
3 Christian Herdeg et. al., Local Paclitaxel Delivery for the Prevention of
Restenosis: Biological Effects and Efficacy In Vivo, 35(7) J. OF AM. COLL.
OF CARDIOLOGY 1969-76 (June 2000) ("Herdeg").
4 Roger Charles et al., Ceramide-Coated Balloon Catheters Limit Neointimal
Hyperplasia After Stretch Injury in Carotid Arteries, 87 CIRCULATION
RESEARCH 282-88 (Aug. 18, 2000) ("Charles").
5 WO 99/58123, published Nov. 18, 1999 ("Berge").
6 US 5,824,644, issued Oct. 20 1998 ("Abendschein").
7 US 5,797,887, issued Aug. 25, 1998 ("Rosen").
8 US 5,166,143, issued Nov. 24, 1992 ("Ondetti").
9 CA 2,288,163 Al, published Nov. 5, 1998 ("Krause").
10 US 5,978,698, issued Nov. 2, 1999 ("Sax").
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8. claims 16, 27, 28, 35, 36, and40 overFram, 11 Herdeg, Barry,
and Charles (id. at 1 O);
9. claim 29 over Fram, Herdeg, Barry, Charles, and Abendschein
(id. at 14);
10. claim 30 over Fram, Herdeg, Barry, Charles, and Rosen (id.);
11. claim 31 over Fram, Herdeg, Barry, Charles, and Ondetti (id. at
15);
12. claim 32 over Fram, Herdeg, Barry, Charles, and Krause (id. at
15); and
13. claims 33 and 34 as unpatentable over Fram, Herdeg, Barry,
Charles, and Sax 12 (id. at 15-16).
DISCUSSION
Rejection 1
The Examiner rejected claims 16, 27, 37, and 38 as unpatentable over
Barry, Herdeg, and Charles. Final Act. 3--4.
The Examiner found that Barry teaches a balloon catheter comprising
a paclitaxel-containing layer, but not a paclitaxel-free layer coated thereon.
Ans. 4 (citing Barry 6:24--37, 17:5-24, 17:34--18:2).
11 Daniel B. Fram et al., Localized Intramural Drug Delivery During
Balloon Angioplasty Using Hydrogel-Coated Balloons and Pressure-
Augmented Diffusion, 23(7) INTERVENTIONAL CARDIOLOGY 1570-77 (June
1994) ("Fram").
12 The Examiner's double-patenting rejections were withdrawn. See
Ans. 24--25.
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Application 14/255,392
The Examiner found that Herdeg teaches that local delivery of
paclitaxel via balloon catheter is effective to reduce stenosis and restenosis.
Id. (citing Herdeg abstract).
The Examiner found that Charles teaches a balloon catheter
comprising a paclitaxel-free layer made from dipping the balloon in lipid gel
containing C6 ceramide and that the ceramide is effective at reducing
restenosis after balloon angioplasty. Id. ( citing Charles 282 abstract and col.
1 and 283 col. 1 ).
The Examiner concluded:
A person of ordinary skill in the art at the time of the
invention would have had a reasonable expectation of success in
modifying the balloon catheter of Barry et al. by further coating
the coated balloon catheter with C6 ceramide (lipid) gel (thereby
yielding a "paclitaxel-free layer" coating on the balloon catheter
already coated with a "paclitaxel-containing layer") because
Charles et al. expressly teaches a balloon catheter coated with
ceramide gel. The skilled artisan would have recognized that
(i) balloon catheters coated with paclitaxel for local delivery of
paclitaxel would have been effective to prevent restenosis of the
vessels following balloon angioplasty when delivered directly to
the vessel subjected to angioplasty, as evidenced by Herdeg et
al., and (ii) balloon catheters coated with ceramide gel were
known to have efficacy in preventing vessel restenosis following
balloon angioplasty when delivered locally to the vessel
subjected to angioplasty, as evidenced by Charles et al. The
skilled artisan would have been motivated to provide an
additional coating layer modification to the balloon catheter
because the layered coating of two therapeutic agents, each
known to prevent restenosis when delivered locally to vessels
following angioplasty, would have reasonably provided, at
minimum, additive (if not synergistic) restenosis-preventing
effects when provided by the same balloon catheter device for
local drug delivery.
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Id. 5. We agree with the Examiner's fact-finding, reasoning, and conclusion
that the product of claim 16 would have been obvious based on the cited
references.
Appellants argue that "there is no indication in the cited art or
otherwise provided by the Examiner that a catheter balloon having a
paclitaxel-containing layer (polyurethane loaded with paclitaxel of Barry)
and a paclitaxel-free layer (ceramide of Charles) coated thereon would be
more effective than ceramide alone or paclitaxel alone." Appeal Br. 8. We
are not persuaded. Rather, we agree with the Examiner that there would
have been a "reasonable expectation of at least additive effects from such a
combination" because "each coating (i.e., the paclitaxel coating and the
ceramide gel coating) were individually known to exhibit restenosis-
preventing effects when applied after angioplasty." Ans. 25.
Appellants next argue that "Charles discourages combining ceramide
with another active agent," and offer two purported reasons in support.
Appeal Br. 8. The first reason offered is "because Charles teaches that
ceramide is effective by itself." Id. This argument is not persuasive, as
Appellants have not identified any teaching by Charles that its ceramide-
coated balloon catheter always and completely prevents restenosis after
angioplasty. See id. In other words, Appellants have not established the
premise that a person of ordinary skill in the art would not be interested in
improving the devices/therapy disclosed by Charles. And, per the
Examiner's rejection, it is Barry's device that is being improved by the
addition of Charles's ceramide layer, not the other way around. See Ans. 5;
see also id. at 27 ("[I]t is generally prima facie obvious to use in
combination two or more compositions that have previously been used
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separately for the same purpose." (citing MPEP § 2144.06(!)); see also In re
Kerkhoven, 626 F.2d 846, 850 (CCPA 1980) ("It is primafacie obvious to
combine two compositions each of which is taught by the prior art to be
useful for the same purpose, in order to form a third composition which is to
be used for the very same purpose .... [T]he idea of combining them flows
logically from their having been individually taught in the prior art.").
The second reason argued by Appellants for why a person of ordinary
skill in the art would have been discouraged from combining ceramide with
another active agent is because "Charles suggests that the use of the lipid
metabolite, ceramide, is preferable to the use of non-endogenous derived
compounds that may have increased toxicity." Appeal Br. 8 ( citing Charles
288, col. 1 ); see also Charles 288, col. 1 ("Use of endogenous lipid-derived
metabolites as well as lipomimetic drugs promises high efficacy with low
toxicity."). This argument is not persuasive. The Examiner did not propose
that a person of ordinary skill in the art would have used paclitaxel in lieu of
ceramide. Rather, the Examiner concluded that it would have been obvious
to use both. See, e.g., Ans. 5 ("A person of ordinary skill in the art at the
time of the invention would have had a reasonable expectation of success in
modifying the balloon catheter of Barry et al. by further coating the coated
balloon catheter with C6 ceramide (lipid) gel."). That Charles suggests a
preference for ceramide over paclitaxel does not contradict the Examiner's
conclusion that a person of ordinary skill in the art would have been
motivated to use both in view of Barry, Herdeg, and Charles.
For the foregoing reasons, we affirm the rejection of claim 16 as
unpatentable over Barry, Herdeg, and Charles. Because claims 27, 37, and
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38 were not separately argued (see Appeal Br. 6-10), we also affirm their
rejection over the same references. See 37 C.F.R. § 4I.37(c)(l)(iv).
Rejection 2
In Rejection 2, the Examiner rejected dependent claims 17, 24, 25,
and 39, relying on Barry, Herdeg, and Charles as in Rejection 1 and
additionally on Berge. See Final Act. 6-7. Appellants argue against
Rejection 2 solely on the basis that Berge does not cure the alleged
deficiencies in Rejection 1. See Appeal Br. 10-11. Thus, we affirm
Rejection 2.
Rejections 3-7
In Rejections 3 through 7, the Examiner rejected dependent claims
18-23 relying on Barry, Herdeg, Charles, and Berge as in Rejection 1 and
additional references. See Final Act. 7-9. Appellants argue against
Rejections 3 through 7 solely on the basis that the additional references do
not cure the alleged deficiencies in Rejection 2. See Appeal Br. 11-12.
Thus, we affirm Rejections 3 through 7.
Rejection 8
The Examiner rejected claims 16, 27, 28, 35, 36, and 40 over Fram,
Herdeg, Barry, and Charles, citing Barry and Charles for their teachings as
discussed above. Final Act. 10; Answer 15-16. Appellants argue against
Rejection 8 on the basis that Fram does not cure the deficiencies in Rejection
I. See Appeal Br. 12 ("Fram does not cure the deficiencies of Herdeg,
Barry, and Charles."). In that vein, Appellants repeat the same arguments,
adapting them to the references at issue, stating:
. . . [T]here is no indication in the cited art or otherwise
provided by the Examiner that a catheter balloon having a
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paclitaxel-containing layer (hydrogel loaded with paclitaxel of
Fram in view of Barry) and a paclitaxel-free layer (ceramide of
Charles) coated thereon would be more effective than ceramide
alone or paclitaxel alone.
Moreover, Charles discourages combining ceramide with
another active agent, at least because Charles teaches that
ceramide is effective by itself and because Charles teaches an
advantage of using endogenous lipid-derived agents includes
high efficacy with low toxicity.
Appeal Br. 13. These arguments were not persuasive above. Nor are they
here.
Accordingly, we affirm Rejection 8.
Re} ections 9-13
In Rejections 9 through 13, the Examiner rejected dependent claims
29-34, relying on Fram, Herdeg, Barry, and Charles as in Rejection 8 and
additional references. See Final Act. 14--16. Appellants argue against
Rejections 9 through 13 solely on the basis that the additional references do
not cure the alleged deficiencies in Rejection 8. See Appeal Br. 15-16. 13
Thus, we affirm Rejections 9 through 13.
DECISION
The Examiner's rejection of claims 16-25 and 27--40 is affirmed.
13 In presenting this argument, Appellants referred to the alleged deficiencies
of Herdeg, Barry, Charles, and Berge (Rejection 2), but we presume
Appellants intended to refer to Fram, Herdeg, Barry, and Charles (Rejection
8). See Appeal Br. 15 ("Each of Adendschein, Rosen, Ondetti, Karuse, and
Sax fails to cure the deficiencies of Herdeg, Barry, Charles, and Berge.").
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TIME PERIOD
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED
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