Ex Parte Martinez

Board of Patent Appeals and Interferences

Mar 6, 2012

10631981 (B.P.A.I. Mar. 6, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte GEORGE MARTINEZ
____________

Appeal 2010-006551
Application 10/631,981
Technology Center 3700
____________

Before JENNIFER D. BAHR, LINDA E. HORNER, and
WILLIAM V. SAINDON, Administrative Patent Judges.

HORNER, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
George Martinez (Appellant) seeks our review under 35 U.S.C. § 134
of the Examiner’s decision rejecting claims 1-67 under 35 U.S.C. § 103(a) as
unpatentable over Sepetka (US 2002/0169473 A1; pub. Nov. 14, 2002),
Rosenthal (US 7,066,904 B2; iss. Jun. 27, 2006), and Kopecek
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(WO 98/01421; pub. Jan. 15, 1998). We have jurisdiction under 35 U.S.C.
§ 6(b). We REVERSE.
THE INVENTION
Appellant’s claimed invention “relates to vaso-occlusive devices, such
as vaso-occlusive coils and the like, for the embolization of vascular
aneurysms and similar vascular abnormalities.” Spec. 1, ll. 12-14. Claim 1,
reproduced below, is representative of the subject matter on appeal.
1. A vaso-occlusive implant, comprising:
an elongate, flexible, filamentous inner element;
a non-metallic expansile intermediate element coaxially
surrounding the inner element and in intimate contact therewith
substantially along the length of the inner member, said
expansile intermediate element capable of expanding at a
controlled rate to fill an aneurysm; and
an outer element coaxially surrounding the intermediate
element and in intimate contact therewith, the outer element
defining a gap or opening through which the intermediate
element is exposed.
Independent claims 14, 29, 40, and 52 similarly recite a vaso-
occlusive implant comprising three elements including an inner element, an
expansile intermediate element, and an outer element defining a gap or
opening through which the intermediate element is exposed. Independent
claims 66 and 67 are directed to a vaso-occlusive device comprising an
expansile member/element and an open-coiled element/second member,
wherein portions of the expansile member expand through openings between
the coils of the open-coiled element/second member.
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CONTENTIONS AND ISSUE
The Examiner determined that Sepetka discloses an inner element
(main coils 352), an intermediate element (a drug coating), and an outer
element (secondary coils 354) defining a gap or opening through which the
intermediate element is exposed, but “does not disclose the intermediate
element being an expansile polymeric material that is a hydrogel.” Ans. 3-4.
The Examiner found that Rosenthal teaches an expansile hydrogel for
providing drug delivery and that Kopecek teaches that it was known in the
art for hydrogel to swell at a chemically controlled rate when there is a
change in pH. Ans. 4-5. The Examiner determined:
[O]ne skilled in the art could have combined the elements as
claimed by known methods with no change in their respective
functions and the combination would have yielded predictable
results to one of ordinary skill in the art at the time of the
invention, namely a way of delivering a drug in a controlled
manner via the use of hydrogel and a triggering mechanism.
Ans. 4.
Appellant argues:
[A] hydrogel coating on the main coils 352 would expand
inward within healthy portions of the vessel, occluding the
healthy portions of the vessel and causing serious complications
such as a stroke. Hence, it would be extremely dangerous to use
a Sepetka stent with a hydrogel coating on the main coils 352.
App. Br. 8.
The issue presented by this appeal is whether the Examiner’s proposal
to add an expansile hydrogel for providing drug delivery to the inner coils of
Sepetka’s device is based on a rational underpinning.
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ANALYSIS
Sepetka discloses a device for treating an aneurysm having a central
opening through which embolic materials may be delivered. Para. [0166].
Sepetka discloses that the opening may be provided by larger spacings
between the main coil 352 or secondary windings 354, or may be formed by
omitted elements in the main coil 352 or secondary windings 354. Id., figs.
67-69. Sepetka discloses that “[e]mbolic elements 368, such as embolic
coils, gels, glue, or hydrogels may be delivered through the opening 364. In
one aspect, the device 352 is used to deliver a hydrogel 370 which is
delivered as in elongate section or filament 371.” Id. at [0166]. Thus, while
Sepetka discloses delivering an expansible hydrogel through an opening
formed by spacing in the secondary winding, the hydrogel is not disposed as
an intermediate element coaxially surrounding the main coil, as called for by
independent claims 1, 14, 29, 40, and 52. We agree with Appellant that if
such a modification were made to Sepetka for drug delivery, as proposed by
the Examiner, the hydrogel coating on the main coils 352 would expand
inwardly within healthy portions of the vessel, occluding the healthy
portions of the vessel and potentially causing serious complications such as a
stroke. See App. Br. 8. As such, the Examiner’s proposed modification
lacks a rational underpinning and we do not sustain the rejection of
independent claims 1, 14, 29, 40, and 52 and their dependent claims 2-13,
15-28, 30-39, 41-51, and 53-65, over Sepetka, Rosenthal, and Kopecek.
Independent claim 66 calls for a second member helically surrounding
an expansile first member, such that portions of the first member expand
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through coils of the second member when the device is released in a
vasculature. Independent claim 67 calls for an expansile element having a
second state in which said expansile element is expanded through openings
between coils of an open-coiled element. Sepetka’s main coils 352 and
secondary coils 354 do not helically surround the hydrogel such that the
hydrogel expands through openings in the coils. The Examiner’s rejection
of independent claims 66 and 67 is based on the same deficient proposed
modification of Sepetka discussed supra. Ans. 3-5. Thus, we also do not
sustain the rejection of independent claims 66 and 67 over Sepetka,
Rosenthal, and Kopecek.
CONCLUSION
The Examiner’s proposed modification to add an expansile hydrogel
for providing drug delivery to the inner coils of Sepetka’s device is not
based on a rational underpinning.
DECISION
We REVERSE the decision of the Examiner to reject claims 1-67.

REVERSED

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