Ex Parte Kangas et al

Patent Trial and Appeal Board

May 18, 2018

12815138 (P.T.A.B. May. 18, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/815,138 06/14/2010
11050 7590 05/22/2018
SEAGER, TUFTE & WICKHEM, LLP
100 South 5th Street
Suite 600
Minneapolis, MN 55402
FIRST NAMED INVENTOR
Steve Kangas
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.
2001.1351101 1757
EXAMINER
PARAD, DENNIS J
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
05/22/2018 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):
BSC.USPTO@stwiplaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte STEVE KANGAS, MICHAEL SEAN OWENS,
JON PATTERSON, DA VE EKBERG, ERIK HAUN, ERIC HENDERSON,
AARON FOSS, AND YEN-LANE CHEN
Appeal2017-005994
Application 12/815, 13 81
Technology Center 1600
Before DONALD E. ADAMS, RYAN H. FLAX, and
DAVID COTTA, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL
This Appeal under 35 U.S.C. § 134(a) involves claims 1-3, 6-11, 14--
17, 19, 31, 32, and 54 (Final Act. 2 1). 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 the real party in interest as "Boston Scientific Scimed,
Inc." (App. Br. 3).
2 Office Action mailed December 31, 2015.
3 Appellants' claim 20 stands withdrawn from consideration (Final Act. 1 ).
Appeal2017-005994
Application 12/815, 138
STATEMENT OF THE CASE
Appellants disclose "a method of making a drug delivery balloon
having a coating thereon comprising a drug, wherein the drug has
characteristic amorphous and crystalline forms" (Spec. 2). Claim 1 is
representative and reproduced below:
1. A method of making a drug delivery balloon having a
coating thereon comprising a drug, the balloon made of a
balloon material, the drug selected from the group consisting of
paclitaxel, paclitaxel analogs and paclitaxel derivatives,
wherein the drug has a characteristic amorphous form
and a crystalline form comprising:
a) applying a coating of the drug in the amorphous
form to the balloon material, and, subsequent to applying the
coating,
b) annealing with a solvent vapor the coating which
has been applied in step a), the solvent vapor comprising an
alcohol, to produce the crystalline form of the drug on the
balloon,
wherein in the applying step a) the drug coating is
applied to a balloon surface that has been nucleated by
blooming of a component in the balloon material to the surface
thereof, the component crystallizing at the surface of the
balloon material as a result of the blooming to induce formation
of drug crystals in the annealing step.
(Claims App'x. 4 2 (emphasis added).)
54. A method of making a drug delivery balloon having a
coating thereon comprising a drug, the balloon made of a
balloon material, the drug selected from the group consisting of
paclitaxel, paclitaxel analogs and paclitaxel derivatives,
wherein the drug has a characteristic amorphous form and a
crystalline form comprising:
4 Appellants September 2, 2016 Response to Notification ofNon-Compliant
Appeal Brief.
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Application 12/815, 138
a) applying a coating of the drug in the amorphous
form to the balloon material, and, subsequent to applying the
coating,
b) annealing with a solvent vapor the coating which
has been applied in step a), the solvent vapor comprising an
alcohol, to produce the crystalline form of the drug on the
balloon,
wherein in the applying step the drug coating is applied
to a balloon surface that has been nucleated by treating the
balloon material so as to cause a component from within the
balloon material to migrate to the swface of the balloon
material, the component crystallizing at the surface of the
balloon material and inducing formation of drug crystals in the
annealing step.
(Claims App'x 4 ( emphasis added).)
The claims stand rejected as follows:
Claims 1-3, 6, 7, 9-11, 14, 19, 31, 32, and 54 stand rejected under 35
U.S.C. § I03(a) as unpatentable over the combination of Reyes5 and
Hossainy. 6
Claim 8 stands rejected under 35 U.S.C. § I03(a) as unpatentable over
the combination of Reyes, Hossainy, and Amey. 7
Claims 15-17 stand rejected under 35 U.S.C. § I03(a) as unpatentable
over the combination of Reyes, Hossainy, and Parsonage. 8
5 Reyes et al., US 2008/0020013 Al, published Jan. 24, 2008.
6 Hossainy et al., US 2005/0186248 Al, published Aug. 25, 2005.
7 Amey et al., US 2007/0178136 Al, published Aug. 2, 2007.
8 Parsonage et al., US 2006/0088566 Al, published Apr. 27, 2006.
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Appeal2017-005994
Application 12/815, 138
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Reyes "relates to releasable taxane therapeutic agent coatings for
endolumenal medical devices, including stents" (Reyes ,r 2).
FF 2. Reyes "coatings include[] a taxane therapeutic agent in a layer that is
free of a polymer that alters the release rate of the therapeutic agent" (Reyes
,r 23; see also id. ,r 60).
FF 3. Reyes discloses "methods of manufacturing and treating therapeutic
taxane coatings on medical devices," wherein "the methods comprise a
conditioning step ... that converts a portion of paclitaxel from an
amorphous solid form to a hydrated solid form that is slower-eluting than the
amorphous solid form" (Reyes ,r 17; see id. ,r 18 ("[t]he post-deposition
treatment of a medical device coating comprising a taxane therapeutic agent,
or 'conditioning' of the coating, is performed to alter the solid form
composition of taxane therapeutic agent in the coating") ( emphasis added));
id. ,r 59 (Reyes' "[m]ethods preferably comprise the steps of depositing or
providing a taxane therapeutic agent on a medical device in a first solid form
in a coating, followed by conditioning the coating to provide a coating
comprising a second solid form having desirable solubility and durability
properties")).
FF 4. Reyes discloses:
The recitation of "conditioning of a coating" refers to
subjecting a coating to physical conditions effective to change
the durability and/or solubility of the coating in an elution
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Application 12/815, 138
medium. The physical conditions of conditioning may include
maintaining the coating at a specified temperature and/ or
humidity for a specified period of time. Alternatively,
conditioning may include contacting the coating with a fluid,
such as water or steam. The conditioning of a coating
preferably provides a desired modification of physical
properties, such as durability or elution rate, suitable for an
intended use. For example, a coating comprising a paclitaxel
taxane therapeutic agent as an amorphous paclitaxel solid form
may be conditioned by maintaining the coating at a temperature
and a relative humidity for a time period effective to provide a
dehydrate paclitaxel solid form within the coating.
(Reyes ,r 68; see generally id. ,r,r 98-108; see also id. ,r 122 ("[b]ulk samples
of anhydrous taxane therapeutic agent can be prepared by dissolving a
taxane therapeutic agent such as paclitaxel in any suitable alcohol-based
solvent, followed by evaporation of the solvent to leave a[] crystalline
solid"); id. ,r 143 ("ultrasonic spray coating is preferably performed at an
ambient temperature of about 85-8Q F[] and in a coating chamber at a
pressure of less than about 0.05 psi," wherein "[t]he temperature during
ultrasonic spray coating should be high enough to rapidly evaporate the
methanol in the spray solution before contacting the stent").)
FF 5. Hossainy discloses:
Local administration of therapeutic agents via stents has shown
some favorable results in reducing restenosis. However, the
properties of stent coatings can be improved. For example,
when the outermost layer of the coating comprises a blend of
hydrophobic and hydrophilic polymers, the hydrophobic
polymers tend to bloom to coating-air interface. Yet, in many
applications it is highly desirable to have hydrophilic polymers
evolve at the coating-air interface to provide the stent coating
with better blood compatibility, biological activity and non-
fouling properties. Accordingly, the present invention discloses
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Application 12/815, 138
such improved stent coatings and methods for fabricating
thereof.
(Hossainy ,r 9; see also id. ,r,r 20, 33-35, 40 (discussing the post-coating
treatment of a coated stent resulting in the blooming of the hydrophilic
polymer component of the coating to the coating-air interface).)
ANALYSIS
Based on the combination of Reyes and Hossainy, Examiner
concludes that, at the time Appellants' invention was made, it would have
been prima facie obvious to modify Reyes coating method to include
Hossainy' s polymer drug coating, such that after, or post-coating, the
polymer drug coated device is treated such that a hydrophilic component of
the polymer drug coating blooms to the coating-air interface (see Ans. 5).
We are not persuaded.
Examiner has, at best, established that the combination of Reyes and
Hossainy suggest a method wherein after a polymer drug coating is applied
to a medical device, the polymer drug coating may be treated to cause the
blooming of a component of a polymer drug coating to the coating air
interface (see FF 1-5; Ans. 5). This is, however, not what Appellants' have
claimed. To the contrary, Appellants' independent claim require, inter alia,
blooming of a component in the balloon material, i.e. blooming of a
component of the device, to the surface of the balloon material prior to
application of the drug coating (see Claims App 'x. 2 ("the drug coating is
applied to a balloon surface that has been nucleated by blooming of a
component in the balloon material to the surface thereof') ( emphasis added);
id. at 4 ("the drug coating is applied to a balloon surface that has been
nucleated by treating the balloon material so as to cause a component from
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Application 12/815, 138
within the balloon material to migrate to the surface of the balloon
material") ( emphasis added)).
For the reasons set forth above, we are not persuaded by Examiner's
assertion that Appellants' "claims do not recite blooming of the balloon
material component and nucleation of that component of the balloon
material before application of the amorphous drug" or that Appellants'
"'balloon material' may broadly include any coatings to the surface thereof'
(Ans. 10, 14; cf App. Br. 8-9, 10, 13-14; Reply Br. 3, 9).
Examiner further failed to establish an evidentiary basis on this record
to support a conclusion that Amey or Parsonage make up for the foregoing
deficiency in the combination of Reyes and Hossainy (see Ans. 6-9; cf App.
Br. 19-20; Reply Br. 17-18).
CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness.
The rejection of claims 1-3, 6, 7, 9-11, 14, 19, 31, 32, and 54 under
35 U.S.C. § 103(a) as unpatentable over the combination of Reyes and
Hossainy is reversed.
The rejection of claim 8 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Reyes, Hossainy, and Amey is reversed.
The rejection of claims 15-17 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Reyes, Hossainy, and Parsonage is
reversed.
REVERSED
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