Ex Parte Knapp

Board of Patent Appeals and Interferences

Oct 12, 2010

11598903 (B.P.A.I. Oct. 12, 2010)

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.
11/598,903 11/14/2006 David Knapp 00-0118US2 1654
27774 7590 10/12/2010
MAYER & WILLIAMS PC
251 NORTH AVENUE WEST
2ND FLOOR
WESTFIELD, NJ 07090
EXAMINER
CHANNAVAJJALA, LAKSHMI SARADA
ART UNIT PAPER NUMBER
1611
MAIL DATE DELIVERY MODE
10/12/2010 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte DAVID KNAPP
__________

Appeal 2010-006674
Application 11/598,903
Technology Center 1600
__________

Before ERIC GRIMES, DEMETRA J. MILLS, and LORA M. GREEN,
Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL1
This is an appeal under 35 U.S.C. § 134 involving claims to a medical
article that releases a therapeutic agent. The Examiner has rejected the

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.
Appeal 2010-006674
Application 11/598,903

2
claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We
reverse.
STATEMENT OF THE CASE
Claims 1-7, 14, 15, and 22-33 are on appeal. Claim 1 is the only
independent claim and reads as follows:
1. A therapeutic medical article comprising:
a medical article;
a precursor compound; and
an activator compound, wherein said medical article is adapted, upon
placement at an administration site within the body of a patient, to release
said precursor compound and said activator compound such that said
activator compound interacts with said precursor compound and converts
said precursor compound into activated form that is a therapeutic agent for
local delivery within the body of said patient.

Issue
The Examiner has rejected claims 1-7, 14, 15, and 22-33 under 35
U.S.C. § 103(a) as being obvious in view of Papandreou.2
The Examiner finds that Papandreou discloses a medical device “that
is loaded with an agent comprising a sulfhydryl group (thiol group)
(precursor compound) and further treated with a nitric oxide (NO) carrier
(activator compound)” (Answer 4), and that interaction of the sulfhydryl
groups with the NO carrier results “in the release of nitric oxide directly at
the target site” (id.). The Examiner concludes that “it would have been
obvious for one of an ordinary skill in the art … to coat [the] medical stents
of [Papandreou] with a thiol group containing agent and further with an NO
donor containing compound because [Papandreou] teaches that the liberation

2 Papandreou et al., US 6,171,232 B1, Jan. 9, 2001.
Appeal 2010-006674
Application 11/598,903

3
of nitric oxide from vasodilators, particularly NO donors, is potentiated by
the thiol donors” (id. at 5).
Appellant contends that Papandreou provides “no teaching or
suggestion to release a precursor compound (e.g., thiol) and an activator
compound (e.g., nitric oxide donor) such that the activator compound
interacts with the precursor compound and converts said precursor
compound into activated form” (Appeal Br. 4-5).
The issue presented is: Does the evidence of record support the
Examiner’s conclusion that Papandreou suggests a medical device that is
adapted to release both a precursor compound and an activator compound?
Findings of Fact
1. Papandreou discloses “coated medical devices…. More
particularly, a thiol group containing agent is loaded onto a medical device
for in vivo interaction with a nitric oxide donor” (Papandreou, col. 1, ll. 5-9).
2. Papandreou discloses that, in a “preferred embodiment, protected
sulfur containing compounds are covalently attached onto medical device
surfaces of polymer-coated metals, polymers and the like. These thus
immobilized compounds … are useful for enhancing local release of nitric
oxide in vivo” (id. at col. 1, ll. 9-14).
3. Papandreou discloses that a “further object of the present invention
is to provide medical devices having sulfhydryl groups on their working or
engagement surfaces to provide the favorable property of accelerating
release of nitric oxide locally when patients within which the medical
devices are implanted are administered nitrovasodilators such as
nitroglycerin” (id. at col. 2, ll. 47-52).
Appeal 2010-006674
Application 11/598,903

4
4. Papandreou discloses that “the nitric oxide donor or provider is
delivered to the treatment location by any of several different approaches.
These include oral ingestion, … and loading onto the medical device prior to
its implantation or insertion” (id. at col. 5, ll. 7-13).
5. Papandreou illustrates the covalent attachment of the sulfhydryl
containing compounds to a polymer deposited on a medical device (id. at
col. 5, l. 15-col. 6, l. 33, Fig. 1 and Fig. 2).
Principles of Law
“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
argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993).
Analysis
Claim 1 is directed to a therapeutic medical article that is adapted to
release a precursor compound and an activator compound such that the
activator compound converts the precursor compound into an activated,
therapeutic form, when the article is placed in a patient’s body.
Appellant argues that Papandreou does not suggest devices that
release both a precursor compound and an activator compound (Appeal Br.
4-5, Reply Br. 4).
Appellant’s argument is persuasive. Although Papandreou’s device
can be loaded with both a sulfhydryl group-containing compound and a NO-
donor compound, Papandreou discloses that the sulfhydryl-containing
Appeal 2010-006674
Application 11/598,903

5
compounds are preferably covalently attached to the medical device and
describes them as “immobilized compounds” (FF 2). The Examiner has not
pointed to any passage in Papandreou that describes the sulfhydryl-
containing compounds as being released from the medical device.
The Examiner finds that “a skilled artisan would have expected the
release of the two (precursor and activator) compounds from the article of
[Papandreou] (see column 2, lines 47-52)” (Answer 8-9). We do not agree
that this passage supports the Examiner’s position. This passage (quoted
above in FF 3) describes Papandreou’s devices as “having sulfhydryl groups
on their working or engagement surfaces” (FF 3), not releasing sulfhydryl
groups from those surfaces.
Thus, we are compelled to conclude that the Examiner has not
adequately explained how Papandreou suggests a medical device that
releases both a precursor compound and an activator compound. The
rejection of claim 1, and dependent claims 2-7, 14-15 and 22-33, is reversed.
Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that Papandreou suggests a medical device which is adapted to release both a
precursor compound and an activator compound.
SUMMARY
We reverse the rejection of claims 1-7, 14-15 and 22-33 under 35
U.S.C. § 103(a).

REVERSED
Appeal 2010-006674
Application 11/598,903

6

cdc

MAYER & WILLIAMS PC
251 NORTH AVENUE WEST
2ND FLOOR
WESTFIELD, NJ 07090