Ex Parte Reinprecht et al

Patent Trial and Appeal Board

Mar 22, 2017

13589222 (P.T.A.B. Mar. 22, 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.
13/589,222 08/20/2012 Jon T. Reinprecht H-US-03224 (203-8536) 8544
50855 7590
Covidien LP
60 Middletown Avenue
c/o Legal - Mailstop MS 54
North Haven, CT 06473
EXAMINER
MILLIGAN, ADAM C
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
03/24/2017 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):
SurgicalUS@covidien.com
medtronic_mitg-si_docketing@cardinal-ip.com
mail @ cdfslaw. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JON T. REINPRECHT, SETH GLEIMAN,
AMIN ELACHCHABI, RYAN WITHERALL, JOSHUA STOPEK, and
GARRETT EBERSOLE1
Appeal 2016-006181
Application 13/589,222
Technology Center 1600
Before JEFFREY N. FREDMAN, JOHN E. SCHNEIDER,
and RYAN H. FLAX, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134 involving claims to medical
devices, which have been rejected as obvious. We have jurisdiction under 35
U.S.C. § 6(b).
We reverse.
1 Appellants identify the Real Party in Interest as Covidien LP. Appeal
Br. 1.
Appeal 2016-006181
Application 13/589,222
STATEMENT OF THE CASE
The Specification describes a medical device comprising a melt-
pressed film between two sprayed coated diffusion layers. Spec. 1 5. The
melt-pressed film may comprise a therapeutic agent. Spec. 1 6.
Claims 1—8, 10-12, 17, and 18 are on appeal. Claim 1 is
representative of the rejected claims and reads as follows:
1. A medical device comprising:
a first spray coated diffusion barrier layer,
a second spray coated diffusion barrier layer, and
a melt-pressed film comprising a therapeutic agent disposed
therebetween.
The claims stand rejected as follows.2
Claims 1, 2, 4-8, and 10-12 have been rejected under 35 U.S.C.
§ 103(a) as unpatentable over Roorda3 in view of McClain.4
Claims 1-8, 10-12, 17, and 18 have been rejected under 35 U.S.C.
§ 103(a) as unpatentable over Roorda in view of McClain in further view of
Ebersole.5
2 In the Final Action the Examiner rejected the pending claims for
obviousness-type double patenting over claims of copending Application
No. 12/701,987. Final Act. 5—6. Application 12/701,987 was abandoned on
July 20, 2012, rendering the rejection moot.
3 Roorda et al., US 5,571,525, issued Nov. 5, 1996 (“Roorda”).
4 McClain et al., US 2010/0239635 Al, published Sept. 23, 2010
(“McClain”).
5 Ebersole et al., US 2010/0087840 Al, published Apr. 8, 2010 (“Ebersole”).
2
Appeal 2016-006181
Application 13/589,222
ROORDA COMBINED WITH McCLAIN
Issue
The issue with respect to this rejection is whether a preponderance of
evidence supports the Examiner’s finding that claims 1, 2, 4—8, and 10-12
would have been obvious over Roorda combined with McClain. We agree
with Appellants that it does not.
“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.’ The patent applicant may
then attack the Examiner’s prima facie determination as improperly made
out, or the applicant may present objective evidence tending to support a
conclusion of nonobviousness.” In reFritch, 972 F.2d 1260, 1265 (Fed. Cir.
1992) (citations omitted).
Roorda teaches the use of bioerodible polymers for use as drug
delivery vehicles. Roorda Abstract. Roorda teaches that “[degradation of
the polymer is potentially the greatest contributing factor to the release of
the drug.” Roorda col.2,11. 9-10. McClain teaches a polymeric coating for
medical devices that provides “substantial protection” to the device.
McClain 13. We agree with Appellants (see Appeal Br. 5) that one skilled
in the art would not have been motivated to combine the teachings of
McLain with those of Roorda because the addition of a protective layer
would defeat the purpose of using the bioerodible polymer of Roorda.
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Appeal 2016-006181
Application 13/589,222
In addition, the Examiner has not shown any teaching in the
references that would lead one skilled in the art to make the proposed
combination. In addition to providing a protective layer, the coatings of
McClain contain an active agent. McClain 13. The Examiner has not
pointed to any teaching in the cited art that would lead one skilled in the art
to add a drug containing layer on top of an already present drug delivery
polymer film.
The Examiner suggests that one skilled in the art would add the
polymer layer of McClain to the film of Roorda as a means to control the
degradation of the polymer in Roorda. Ans. 7. We are not persuaded. As
Appellants point out, Roorda teaches that the degradation of the polymer in
Roorda can be adjusted by controlling the amount of erosion rate modifier
present in the polymer. Appeal Br. 3—4, Reply Br. 2. We agree with
Appellants that the Examiner has not pointed to anything in the references
that would lead one skilled in the art to add the layer of McClain to the film
of Roorda.
We conclude that a preponderance of the evidence does not support
the Examiner’s finding of obviousness.
ROORDA COMBINED WITH McCLAIN AND EBERSOLE
The Examiner’s rejection based on Roorda combine with McClain
and Ebersole is essentially the same as the rejection discussed above. Final
Act. 4. The Examiner cites Ebersole solely to address the limitations
reciting specific copolymers. Id. For the reasons stated above, we also
reverse the rejection of claims 1—8, 10-12, 17, and 18 as obvious over
Roorda combined with McClain and Ebersole.
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Appeal 2016-006181
Application 13/589,222
SUMMARY
We reverse the rejections under 35 U.S.C. § 103(a).
REVERSED
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