Ex Parte Stopek et al

Patent Trial and Appeal Board

Nov 6, 2014

12544444 (P.T.A.B. Nov. 6, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE PATENT TRIAL AND APPEAL BOARD
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Ex parte JOSHUA B. STOPEK, MATTHEW D. COHEN,
JOSEPH HOTTER, and WILLIAM DENMAN
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Appeal 2012-009746
Application 12/544,444
Technology Center 3700
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Before STEFAN STAICOVICI, MICHAEL L. WOODS, and
LEE L. STEPINA Administrative Patent Judges.

WOODS, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Joshua B. Stopek et al. (“Appellants”) seek our review under
35 U.S.C. § 134 of the final rejection of claims 1–8 and 11. Appeal Br. 2.
Claims 9 and 10 have been cancelled. Id. We have jurisdiction under
35 U.S.C. § 6(b).
We REVERSE.
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CLAIMED SUBJECT MATTER
The Appellants’ invention is directed to packaging for medical
devices. See, e.g., Spec. 1. Claim 1 is the sole independent claim and is
reproduced below with emphasis on a key disputed claim limitation.
1. A medical device package comprising:
a medical device;
at least one solid self-contained agent in a form selected
from the group consisting of capsule, tablet, pellet, and pressed
powders;
a container having an area configured for receiving the
medical device, and the at least one solid self-contained agent;
and
a port for permitting the sterile passage of a contact
material between the outside of the container and the at least
one solid self-contained agent.

THE REJECTIONS
The Examiner rejects (Answer 5–8):
(i) claims 1, 2, 4–6, and 11 under 35 U.S.C. § 103(a) as being
unpatentable over Vonderwalde (US 2005/0278012 A1, published Dec. 15,
2005) in view of Hein (US 3,369,708, issued Feb. 20, 1968) and Florjancic
(US 5,275,185, issued Jan. 4, 1994);
(ii) claim 3 under 35 U.S.C. § 103(a) as being unpatentable over
Vonderwalde, Hein, Florjancic, and further in view of Totakura
(US 5,954,748, issued Sept. 21, 1999); and
(iii) claims 7 and 8 under 35 U.S.C. § 103(a) as being unpatentable
over Vonderwalde, Hein, Florjancic, and further in view of Levy
(US 5,698,210, issued Dec. 16, 1997).

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ANALYSIS
Rejections (i), (ii), and (iii) - Claims 1–8 and 11 as Unpatentable
In rejecting claim 1, including its dependent claims 2–8 and 11, the
Examiner finds that Vonderwalde discloses, inter alia, a medical device
package including container (sheath) 18 having an area configured for
receiving medical device (stent) 17, and protective fluid 19 containing a
drug.1 Answer 5–8. The Examiner further finds that Vonderwalde fails to
disclose the drug being a capsule, tablet, pellet, or pressed powders, but
determines that “[i]t would have been obvious . . . to have made the drug of
Vonderwalde into pellets separated from the protective fluid for the
predictable result of extending the shelf life of the drug as taught by Hein.”
Id. at 5 (citing Hein, col. 1, ll. 14–16; col. 2, ll. 12–31; and Fig. 1).
Figure 1 of Vonderwalde is reproduced below:

Figure 1 depicts “container” 18, stent 17, and protective fluid 19.
In response, the Appellants argue that “the Examiner’s alleged
combination . . . would render the both the [sic] container and the protective
fluid of Vonderwalde inoperable for its intended purpose, [which is] to

1 Nomenclature in parenthesis represents that used in Vonderwalde.
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Application 12/544,444

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protect the medical device and ensure the device is moist and/or ready to be
used when the package is opened.” Reply Br. 5. In support of their
argument, the Appellants cite to Vonderwalde, which provides that
Vonderwalde’s container “is configured to maintain a body of protective
fluid about the mounted stent to ensure that the device is ready to be used by
the physician when the package is open with little or no preparation.” Id.
(citing Vonderwalde, para. 14) (emphasis added).
If the proposed modification would render prior art invention being
modified unsatisfactory for its intended purpose, there is no suggestion or
motivation to make the proposed modification. In re Gordon, 733 F.2d 900
(Fed. Cir.1984).
We find that modifying and replacing Vonderwalde’s protective fluid
19 with pellets would render the protective fluid unsatisfactory for its
intended purpose, which is to “minimize[ the] detrimental affects to the stent
18 and allow[] the stent to be used by the physician upon removal from the
package.” Vonderwalde, para. 36; see also id. at paras. 11, 14, and 24.
Apparently, the presence of protective fluid 19 increases the storage life of
certain drug-eluting stents by minimizing the stent’s “exposure to oxygen
during lengthy distribution and storage periods.” See id. at para. 11; see also
id. at paras. 14, 24, and 36. Accordingly, a person of ordinary skill in the art
at the time of the invention would not have found it obvious to replace
Vonderwalde’s protective fluid with pellets “to extend the shelf life,” as the
Examiner proposes, as doing so would seemingly have the opposite effect.
Answer 5 (citing Hein, col. 1, ll. 14–16).
The Examiner’s use of Florjancic, Totakura, and Levy does not
remedy the deficiencies of Vonderwalde and Hein as described supra. See
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Answer 5–8. Therefore, for the foregoing reasons, we do not sustain the
rejections under 35 U.S.C. § 103(a) of claims 1–8 and 11 as unpatentable
over Vonderwalde and the other cited art, as set forth under rejections (i),
(ii), and (iii), above.

SUMMARY
The Examiner’s decision to reject claims 1–8 and 11 is reversed.

REVERSED

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