Ex Parte Weber

Patent Trial and Appeal Board

Nov 18, 2015

12720223 (P.T.A.B. Nov. 18, 2015)

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.
12/720,223 03/09/2010 Jan Weber 08-00149US2 (4010/318) 8617
94173 7590 11/18/2015
Fish & Richardson PC
P.O.BOX 1022
Minneapolis, MN 55440
EXAMINER
BECKHARDT, LYNDSEY MARIE
ART UNIT PAPER NUMBER
1613
MAIL DATE DELIVERY MODE
11/18/2015 PAPER
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.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte JAN WEBER
__________

Appeal 2013-004747
Application 12/720,223
Technology Center 1600
__________

Before DEMETRA J. MILLS, ULRIKE W. JENKS, and
JACQUELINE T. HARLOW, Administrative Patent Judges.

MILLS, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
STATEMENT OF CASE
The following claim is representative.
1. An implantable or insertable medical device comprising (a) a
substrate, (b) a drug-containing layer over the substrate, said drug-containing
layer comprising a drug and a rupturing element, and (c) a carbon layer
disposed over said drug-containing layer, wherein said rupturing element acts
to rupture the carbon layer during or after implantation or insertion of said
device.
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Cited References

Hossainy et al. US 2003/0104028 A1 June 5, 2003
(hereinafter “Hossainy” or ‘028)

Wu et al. US 6,805,898 B1 Oct. 19, 2004
(hereinafter “Wu” or ’898)

Laurent et al. US 2006/0047242 A1 Mar. 2, 2006
(hereinafter “Laurent” or ‘242)

Weber US 2007/0106363 A1 May 10, 2007

FINDINGS OF FACT
We adopt the Examiner’s findings of fact, which are set forth in the
Answer at pages 3–15.
PRINCIPLES OF LAW
In making our determination, we apply the preponderance of the
evidence standard. See, e.g., Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427
(Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings
before the Office). The Board “determines the scope of claims in patent
applications not solely on the basis of the claim language, but upon giving
claims their broadest reasonable construction ‘in light of the specification as
it would be interpreted by one of ordinary skill in the art.’” Phillips v. AWH
Corp., 415 F.3d 1303, 1316 (Fed. Cir. 2005) (quoting In re Am. Acad. of Sci.
Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004).
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or
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Application 12/720,223

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argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993) (citations omitted). In order to determine whether a prima facie
case of obviousness has been established, we consider the factors set forth in
Graham v. John Deere Co., 383 U.S. 1, 17 (1966): (1) the scope and content
of the prior art; (2) the differences between the prior art and the claims at
issue; (3) the level of ordinary skill in the relevant art; and (4) objective
evidence of nonobviousness, if present.
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
ANALYSIS
Rejection 1
Claims 1–5 and 8–12 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Wu in view of Laurent and Hossainy.
We agree with the Examiner’s fact finding, statement of the rejection
and responses to Appellant’s arguments as set forth in the Answer. We find
that the Examiner has provided evidence on this record to support a prima
facie case of obviousness. We provide the following additional comment to
the Examiner’s response set forth in the Final Rejection and Answer.
Appellant contends that
While it is true that Wu teaches that polymers for coating the
device may be biostable or biodegradable Wu does not teach
the use of an inorganic material such as diamond-like carbon.
Moreover, the only drug regulating layer described in Wu is an
outer drug layer which releases drug from an underlying drug
layer after the outer drug-containing layer has wholly or
partially dissolved (col. 7, line 32-52). Such a dissolvable layer
is completely unlike with the inert diamond-like carbon layer of
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Hossainy, and there is no teaching in Hossainy that the
diamond-like carbon coating is useful as a drug carrier.

App. Br. 5–6. Appellant further argues that, “Laurent, like Wu, does not
teach or suggest the use of a layer between the drug layer(s) and the patient.”
App. Br. 8. Appellant argues that
the introduction of a barrier layer, such as a diamond-like
carbon layer, would impede the sharp asperities of Wu from
penetrating the tissue of the lumen once the implantable device
is expanded, which as taught by Wu, can enhance the ability of
therapeutic substances released from the device coating to reach
target cells and which can help to hold the implantable device
in place in the lumen. In this regard, a proposed modification by
the Examiner cannot render the prior art unsatisfactory for its
intended purpose.

App. Br. 8.

We are not convinced by Appellant’s arguments. We agree with the
Examiner that Wu
teaches the use of multiple drug layers wherein the drug layers
can be applied over the asperities (figure 5C). The ‘898 patent
further teaches the coating layers can be absorbable or biostable
(column 14, lines 60-65) and that the asperities are used to
penetrate the tissue of the lumen after implantation upon
expansion of the device. The penetration is taught to enhance
the release of the drug from the coating (column 7, lines 60-67).
Thus[,] the asperities would penetrate the layer applied over the
asperities in order to penetrate the tissue. The ‘028 publication
teaches a coating for a drug eluting stent comprising a
therapeutic agent containing polymer layer and an inorganic
component for controlling the release wherein the inorganic
component is diamond-like carbon (abstract, [0019]). The ‘242
patent teaches a device which deliver[s] a bioactive substance
and comprises a substrate with micro protrusions (abstract,
[0012]) wherein the membrane is pierced to deliver a
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therapeutic agent [0052]. It would have been obvious to one of
ordinary skill the drug regulating layer could be the diamond
like coating layer taught by the ‘028 publication as the ‘028
publication teaches the use of the diamond like coating layer
over a drug releasing layer to regulate the release of the
therapeutic agent (abstract, [0012]) and further teaches
additional benefits of the use of the carbon layer, such as radio-
opacity of the stent [0021] and chemical inertness [0020].

Ans. 10–11. Thus, Wu teaches the use of a polymer, release layer, or
additional drug layer between the drug layer and the patient. Col. 2, l. 15; 3,
ll. 12-19. Hossainy also teaches that it was well known in the art at the time
of the invention to include a rate limiting barrier made of a gold or diamond-
like carbon in a stent. Abstract. Thus, the Examiner has provided a reason
or motivation to include a gold or diamond-like carbon barrier in a stent.
Additional arguments of Appellant are addressed fully in the Examiner’s
Answer. We adopt the Examiner’s responses to those arguments as our
own.
We also agree with the Examiner that the cited references teach all of
the structural limitations of the instant claims, i.e. the hard sharp structural
elements (asperities) and the carbon coating layer. Therefore the resulting
stent would have been expected by one of ordinary skill in the art to possess
the functional property of rupturing upon implantation or insertion. Ans. 14.
Appellant provides attorney argument but no evidence that the combination
of Hossainy would render Wu inoperable and that Wu would fail to function
for its intended purpose (App. Br. 8). Nor has Appellant provided evidence
that a carbon coating layer such as that of Hossainy provided over the
asperities of Wu would not rupture upon implantation. “Attorney’s
argument in a brief cannot take the place of evidence.” In re Pearson, 494
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F.2d 1399, 1405 (CCPA 1974). We adopt the Examiner’s responses to those
arguments as our own. The rejection is affirmed for the reasons of record.

Rejection 2
Claim 11 is rejected under 35 U.S.C. § 103(a) as being unpatentable
over Wu in view of Laurent, Hossainy and Weber.
Appellant does not argue claim 11 on the merits, and relies on the
arguments submitted for claim 1. App. Br. 10. Having found no deficiency
with respect to the rejection of claim 1, the rejection of claim 11 is also
affirmed.

CONCLUSION OF LAW
The cited references support the Examiner’s obviousness rejections,
which are affirmed. All claims fall.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

cdc