Ex Parte Schultz et al

Patent Trial and Appeal Board

Jun 12, 2017

13156936 (P.T.A.B. Jun. 12, 2017)

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.
13/156,936 06/09/2011 Karen A. Schultz 49768.21501 6095
7590 06/14/2017
BAKER & HOSTETLER LLP
WASHINGTON SQUARE, SUITE 1100
1050 CONNECTICUT AVE. N.W.
WASHINGTON, DC 20036-5304
EXAMINER
BOWMAN, ANDREW J
ART UNIT PAPER NUMBER
1717
NOTIFICATION DATE DELIVERY MODE
06/14/2017 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):
eofficemonitor@bakerlaw.com
edervis @bakerlaw.com
patents @ bakerlaw. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KAREN A. SCHULTZ, ZHENG ZHANG, CHAD C. HUVAL,
MICHAEL A. BOUCHARD, and CHRISTOPHER R. LOOSE1
Appeal 2016-005645
Application 13/156,936
Technology Center 1700
Before BRADLEY R. GARRIS, CATHERINE Q. TIMM, and AVELYN M.
ROSS, Administrative Patent Judges.
GARRIS, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134, Appellants appeal from the Examiner’s
rejections under 35 U.S.C. § 103(a) of sole independent claim 2 as
unpatentable over Udipi (US 2004/0148003 Al; published July 29, 2004) in
view of Stinson (US 2005/0131522 Al; published June 16, 2005) and Reddy
(US 2008/0234792 Al; published Sept. 25, 2008) and of dependent claims
1 ARROW INTERNATIONAL, INC., is identified as the real party in
interest. App. Br. 1.
Appeal 2016-005645
Application 13/156,936
3—35 as unpatentable over these references alone or in combination with
additional prior art. We have jurisdiction under 35 U.S.C. § 6.
We REVERSE.
Appellants claim an article of manufacture comprising a grafted
polymer layer, a substrate, and a polymeric primer layer between the
substrate and the grafted polymer layer, the substrate comprising a
continuous phase of polymeric material and a discontinuous phase of an
inorganic material wherein the concentration of the inorganic material within
2 micrometers of the substrate surface is less than the concentration at a
distance of at least 20 micrometers from the surface whereby the substrate
surface and the grafted polymer layer in combination constitute a low-
fouling surface having a certain range of fibrinogen adsorption (claim 2).
Further details of this subject matter are set forth in representative
claim 2, a copy of which taken from the Claims Appendix of the Appeal
Brief appears below.
2. An article of manufacture comprising a grafted polymer layer, a
substrate having a surface, and a polymeric primer layer between the
substrate surface and the grafted polymer layer, the substrate comprising a
continuous phase of a polymeric material and a discontinuous phase of an
inorganic material dispersed in the continuous phase, the substrate having a
concentration of the inorganic material that increases as a function of
distance from the substrate surface, the concentration of the inorganic
material within 2 micrometers of the substrate surface being less than the
concentration of the inorganic material at a distance of at least 20
micrometers from the substrate surface, the substrate surface and the grafted
polymer layer, in combination, constituting a low-fouling surface having a
fibrinogen adsorption of less than about 125 ng/cm2 in a fibrinogen binding
assay in which the low-fouling surface is incubated for 60 minutes at 37 °C
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Appeal 2016-005645
Application 13/156,936
in a composition containing 70 jig/ml fibrinogen derived from human
plasma and 1.4 jig/ml 1-125 radiolabeled fibrinogen.
In rejecting claim 2, the Examiner finds that the substrate of Udipi’s
medical stent does not contain the claimed inorganic material including the
claimed material concentration gradient but that Stinson teaches providing a
medical stent with radiopaque inorganic material having a concentration
gradient (Final Action 3). The Examiner additionally finds that, “[although
Stinson only gives one example wherein the amount of radiopaque material
increases [rather than decreases as claimed] near the surface, the concept of
Stinson is applicable in both directions” (id.). Based on these findings, the
Examiner concludes that one having ordinary skill in this art would have
been “motivated to incorporate the radiopaque material of Stinson in a
gradient manner as directed by Stinson [and as claimed] in order to gain both
radiopacity in the stent of Udipi as well as coating layer compliance between
layers” (id. at 4).
Appellants contest the Examiner’s obviousness conclusion by
correctly arguing that Stinson’s disclosed gradient is opposite to the claimed
gradient and relates to a metallic substrate rather than a polymeric substrate
as claimed (App. Br. 9-10 (citing Stinson Fig. 7,1 54)). Appellants also
point out that Stinson’s embodiment having a polymeric substrate with
radiopaque material is made by a technique (i.e., applying the radiopaque
material to the polymeric device, melting the polymer surface, and allowing
the material to fuse with the polymer) which cannot achieve the claimed
gradient (id. at 10 (citing Stinson 176)).
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Appeal 2016-005645
Application 13/156,936
In response, the Examiner urges that the gradient concept taught by
Stinson for a metallic substrate is applicable to a polymeric substrate and is
applicable with respect to the gradient direction taught by Stinson as well as
the opposite gradient direction required by claim 2 (Ans. 4). According to
the Examiner, Stinson would have motivated an artisan to provide Udipi’s
polymeric substrate with radiopaque material having the claimed gradient
“so that the concentration of the radiopaque material in the outside of the
stent [substrate] adjoining the primer layer (which would contain no
radiopaque material) would most closely match the concentration of
radiopaque material in the primer layer” (id.). The Examiner states that an
artisan would not have provided Udipi with a gradient in the reverse
direction because “the result would be the joining of a layer [i.e., Udipi’s
substrate surface] containing a large portion of metallic particles [i.e.,
radiopaque material] with a layer [i.e., Udipi’s primer layer] containing no
metallic particles [whereby] [t]he layers would likely have very different
thermal properties” (id. at 5).
Significantly, the Examiner has provided no evidence in support of
the proposition that, without the claimed gradient, Udipi’s polymeric
substrate and primer layer “would likely have very different thermal
properties” (id.) of such a degree as to detrimentally impact Udipi’s stent. In
the absence of such evidence, the Examiner’s obviousness conclusion
regarding the claimed gradient is merely a conclusory statement sans
rational underpinning. See In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)
(“[Rejections on obviousness grounds cannot be sustained by mere
conclusory statements; instead, there must be some articulated reasoning
with some rational underpinning to support the legal conclusion of
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Appeal 2016-005645
Application 13/156,936
obviousness.”) cited with approval in KSR Int 7 Co. v. Teleflex Inc., 550 U.S.
398,418 (2007).
For these reasons, the § 103 rejections of independent claim 2 and of
dependent claims 3—35 will not be sustained.
The decision of the Examiner is reversed.
REVERSED
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