Ex Parte Belcheva et al

Patent Trial and Appeal Board

Sep 22, 2016

13202357 (P.T.A.B. Sep. 22, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/202,357 11/03/2011
50855 7590 09/26/2016
Covidien LP
555 Long Wharf Drive
Mail Stop SN-I, Legal Department
New Haven, CT 06511
FIRST NAMED INVENTOR
Nadya Belcheva
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.
1600-108 PCT US
(H-SP-000
CONFIRMATION NO.
7831
EXAMINER
BUCKLEY, AUDREA
ART UNIT PAPER NUMBER
1617
NOTIFICATION DATE DELIVERY MODE
09/26/2016 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):
mail@cdfslaw.com
SurgicalUS@covidien.com
medtronic_mitg-si_docketing@cardinal-ip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte NADY A BELCHEV A, FERASS ABUZAINA, AMIN
ELACHCHABI, MBIYA KAPIAMBA, and AHMED ROBERT HADBA. 1
Appeal2014-010013
Application 13/202,357
Technology Center 1600
Before ULRIKE W. JENKS, RICHARD J. SMITH, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method for making a medical device having an activated surface that have
been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.
STATEMENT OF THE CASE
The present invention is directed to a method for making medical
devices with an activated surface. Spec. 1. The method involved subjecting
1 Appellants identify the Real Party in Interest as Coviden LP. Br. 2.
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Application 13/202,357
a portion of the surface of a medical device to plasma treatment and then
attaching a click reactive member to the treated surface. Spec. 2.
Claims 14--17, 19, 21, 22, and 24--27 are on appeal. Claim 14 is
illustrative and reads as follows:
14. A method of preparing a medical device having an
activated surface, the method comprising:
plasma treating at least a portion of a surface of an
absorbable polymeric medical device;
and
attaching one or more click reactive members to the
plasma treated surface of the absorbable polymeric medical
device.
The claims stand rejected as follows:
Claims 14--17, 19, 21, 22, 24, 25, and 27 stand rejected under 35
U.S.C. § 103(a) as unpatentable over Zhao2 in view ofHossainy3.
Claim 26 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over Zhao in view of Hossainy and in further view of Claude. 4
Claims 14--17, 19, 21, 22, 24, and 25 stand rejected on the grounds of
nonstatutory obviousness-type double patenting over claims 17, 19, and 20
of co-pending Application number 13/202, 373 5 in view of Hossainy.
2 Zhao, US 2009/0018646 Al, published Jan. 15, 2009 ("Zhao").
3 Hossainy et al., US 2005/0233062 Al, published Oct. 20, 2005
("Hossainy").
4 Claude et al, US 7,201,935 Bl, issued Apr. 10, 2007 ("Claude").
5 Application 13/202,373 issued as US 8,968,818 B2 on Mar. 3, 2015.
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DISCUSSION
Issue
In rejecting claims 14--17, 19, 21, 22, 24, 25, and 27 the Examiner
relies on the combination of Zhao and Hossainy. The Examiner finds that
Zhao teaches "applying coatings to a medical device wherein a click reactive
member functionalizes an activated surface." Final Act. 6. The Examiner
acknowledges that "Zhao does not teach an absorbable polymeric medical
device having a plasma-treated surface in particular to which the click
reactive member is attached." Id. The Examiner finds that Hossainy teaches
plasma treating argon stents and that this teaches the plasma treating
limitation of the instant claims. Id. The Examiner concludes that
It would have been prima facie obvious to one of ordinary skill
in the art at the time the invention was made to combine the
activated coating method for medical devices using click
chemistry to attach reactive members to a surface as taught by
Zhao \vith a plasma treated surface of an absorbable polymeric
medical device as taught by Hossainy, with a reasonable
expectation of success. One would have been motivated to
combine these prior art elements according to the known
methods to achieve predictable results based on the
functionality of known click chemistry functionalization of
surfaces for use in biological applications as taught by Zhao
and based on the active agent-containing coating methods of
Hossainy (see [0204] for instance).
Final Act. 7.
Appellants contend that Zhao teaches the preparation of an anti-
thrombotic heparin-biocompatible copolymer conjugate which is then used
to coat a medical device. Appeal Br. 4. Appellants also contend that Zhao
does not teach or suggest plasma treatment of at least a portion of the surface
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of a polymeric medical device. Id. Appellants argue that Zhao also fails to
teach or suggest "attaching one or more click reactive members to ... the
absorbable polymeric medical device." Id. With respect to Hossainy,
Appellants argue that Hossainy only teaches plasma treatment of a metal
surface. Appeal Br. 4--5. Appellants argue that a proper combination of the
teachings of Zhao and Hossainy would not lead one skilled in the art to the
claimed invention. Appeal Br. 5.
The issue with respect to this rejection is whether the Examiner has
established by a preponderance of the evidence that claims 14--17, 19, 21,
22, 24, 25, and 27 would have been obvious over Zhao combined with
Hossainy under 35 U.S.C. § 103(a).
Findings of Fact
FF 1. Zhao teaches grafting "a biologically active molecule, such as
heparin, to a biocompatible bioabsorbable polymer via click chemistry."
Zhao i-f 15.
FF2. The grafted polymer of Zhao is applied to the surface of a
medical device using a dip coating or spray coating process. Zhao i1 21.
FF3. Hossainy teaches the manufacture of a drug eluting implantable
medical device such as a stent. Hossainy Abstract.
FF4. Hossainy teaches the use of biologically degradable, erodible,
absorbable and/or reabsorbable polymers for a primer layer. Hossainy
i-f 148.
FF5. Hossainy teaches plasma treatment of the surface of a metal
stent to improve the adhesion of the primer to the stent. Hossainy i1i1 305-
356.
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Principles of Law
"In proceedings before the Patent and Trademark Office, the
Examiner bears the burden of establishing a prima facie case of obviousness
based upon the prior art. '[The Examiner] can satisfy this burden only by
showing some objective teaching in the prior art or that knowledge generally
available to one of ordinary skill in the art would lead that individual to
combine the relevant teachings of the references.'" In re Fritch, 972 F .2d
1260, 1265 (Fed. Cir. 1992) (citations omitted).
Analysis
We agree with Appellants that the Examiner has failed to establish a
prima facie case of obviousness. Appeal Br. 5. The Examiner has not
pointed to any teaching in the references nor have we found any teaching
regarding "plasma treating at least a portion of a surface of an absorbable
polymeric medical device." Appeal Br. 10 (Claims Appendix). We
interpret the claim to require that the polymeric material is plasma treated,
yet we are not directed to any teaching in the references that treat polymeric
material with plasma. Since the combination of references fails to teach all
the limitations of the claims, the rejection cannot be sustained.
Conclusion of Law
We conclude that the Examiner has failed to establish by a
preponderance of the evidence that claims 14--17, 19, 21, 22, 24, 25, and 27
would have been obvious over Zhao combined with Hossainy under 35
U.S.C. § 103(a).
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II
Issue
In rejecting claim 26 the Examiner relies on the teachings of Zhao and
Hossainy as discussed above. The Examiner also finds that Claude teaches
plasma treating a stent for from about 1 to 5 minutes. Final Act. 8. The
Examiner concludes that
[i]t would have been primafacie obvious to one of ordinary
skill in the art at the time the invention was made to use the
plasma activation methodology (i.e., 3 minutes) specified by
Claude in the generally disclosed plasma active methods of
Hossainy, with a reasonable expectation of success. As to a
motivation for combining these teachings, the rationale to
modify or combine the prior art does not have to be expressly
stated in the prior art; the rationale may be expressly or
impliedly contained in the prior art or it may be reasoned from
knowledge generally available to one of ordinary skill in the art,
established scientific principles, or legal precedent established
by prior case law. In the instant case, one would have reasoned
from Hossainy's general teaching that a specific methodology
would have been necessary to achieve the plasma treatment and
would have been motivated to look to Claud, an analogous
teaching, to provide this specific methodology of plasma
treatment, with a reasonable expectation of success.
Final Act. 8-9.
Appellants contend that Claude, combined with Zhao and Hossainy
does not teach the present invention for the reasons stated above. Appellants
also contend that Claude is related to forming a polymeric coating on the
surface of a metal stent. Appeal Br. 6.
The issue with respect to this rejection is whether the Examiner has
established by a preponderance of the evidence that claim 26 would have
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been obvious over Zhao combined with Hossainy and Claude under 35
U.S.C. § 103(a).
Findings of Fact
FF6. Claude teaches coating for medical devices such as stents.
Claude col. 1, 11. 8-9.
FF7. Claude teaches plasma treating the coating for between 2 and 5
minutes.
Analysis
For the reasons stated above, we agree with Appellants that the
Examiner has failed to establish a prima facie case of obviousness. The
Examiner has pointed to nothing in the references to teach or suggest plasma
treating of a medical device comprising an absorbable polymer.
Conclusion of Law
We conclude that the Examiner has failed to establish by a
preponderance of the evidence that claim 26 would have been obvious over
Zhao combined with Hossainy and Claude under 35 U.S.C. § 103(a)
III
Issue
In rejecting claims 14-17, 19, 21, 22, 24, and 25 on the grounds of
obviousness-type double patenting over copending Application No.
13/202,3736 ("the '373 application"), the Examiner finds that "[t]he
6 Application 13/202,373 issued on Mar. 3, 2015 as US 8,968,818 B2.
Claim 1 reads as follows: A method of preparing a medical device having an
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copending claims are drawn to the same method as instantly recited except
that where the instant claims include a limitation to plasma-treating to
provide a coating, the copending claims [of the '3 73 application] include an
acid-treatment or base-treatment to at least a portion of a surface of a
medical device." Final Act. 10. The Examiner goes on to find that
Hossainy teaches plasma treating of at least a portion of the surface of the
device. Id. The Examiner also finds that Hossainy teaches using a
polymeric coating on the device. Final Act. 10-11. The Examiner
concludes that "[i]t would have been primafacie obvious to one of ordinary
skill in the art at the time the invention was made to plasma-treat, and one
would have been motivated to do so for surface functionalization of a stent
product based on Hossainy's teaching of this methodology for achieving a
desirable polymeric coating for drug/stent products." Final Act. 11.
Appellants contend "any proper combination of copending
Application No. 13/202,373 and Hossainy would not have resulted in a
method of preparing a medical device having an activated surface, the
method including 'plasma treating at least a portion of a surface of an
absorbable polymeric medical device."' Appeal Br. 7-8.
The issue with respect to this rejection is whether the Examiner has
established by a preponderance of the evidence that claims 14-17, 19, 21, 22,
activated surface, the method comprising: base-treating at least a portion of a
surface of a medical device; and attaching one or more click reactive
members to the base treated surface of the medical device, wherein the click
reactive members are selected from the group consisting of thiols, azides,
alkynes, and alkenes.
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24, and 25 are unpatentable on the grounds of nonstatutory obviousness-type
double patenting over claims 17, 19, and 20 of copending application
13/202,373 combined with Hossainy.
Analysis
For the reasons set forth above, we agree with Appellants that the
Examiner has failed to establish that the rejected claims would have been
obvious in view of the '373 application combined with Hossainy. The
Examiner has pointed to nothing in Hossainy or the '373 application that
would teach or suggest plasma treating the surface of a polymeric medical
device. Indeed, the claims of the '373 application are directed at base-
treating the surface of the medical device. While Hossainy, as discussed
above, does not plasma treat an absorbable polymeric medical device but
instead teaches "plasma treatment of the surface of a metal stent to improve
the adhesion of the primer [(the polymeric material)] to the stent." FF5.
Accordingly, we agree with Appellants position that the combination does
not render the present claims obvious.
Conclusion of Law
We conclude that the Examiner has failed to establish by a
preponderance of the evidence that claims 14--17, 19, 21, 22, 24, and 25 are
unpatentable on the grounds of nonstatutory obviousness-type double
patenting over claims 17, 19, and 20 of copending application 13/202,373
combined with Hossainy.
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SUMMARY
We reverse the rejection of claims 14--17, 19, 21, 22, 24, 25, and 27
under 35 U.S.C. § 103(a) as unpatentable over Zhao in view ofHossainy.
We reverse the rejection of claim 26 under 35 U.S.C. § 103(a) as
unpatentable over Zhao in view of Hossainy and in further view of Claude.
We reverse the rejection of Claims 14--17, 19, 21, 22, 24, and 25 on
the grounds of nonstatutory obviousness-type double patenting over claims
17, 19, and 20 of co-pending Application number 13/202, 3 73 in view of
Hossainy.
REVERSED
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