Ex Parte Utterberg

Board of Patent Appeals and Interferences

May 13, 2009

11081484 (B.P.A.I. May. 13, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte DAVID S. UTTERBERG
__________

Appeal 2009-4005
Application 11/081,484
Technology Center 3700
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Decided:1 May 13, 2009
__________

Before TONI R. SCHEINER, DONALD E. ADAMS, and
RICHARD M. LEBOVITZ, Administrative Patent Judges.

SCHEINER, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 from the rejection of claims
1-12 and 14-24, all the claims pending. We have jurisdiction under 35
U.S.C. § 6(b).

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, begins to run from the decided date
shown on this page of the decision. The time period does not run from the
Mail Date (paper delivery) or Notification Date (electronic delivery).

Appeal 2009-4005
Application 11/081,484

STATEMENT OF THE CASE
The invention is directed to a medical device for containing fluids,
e.g., a drug vial, with an elastomeric injection site accessible by a needle or a
male luer connector (Spec. 1-2).
Claim 1 is representative of the subject matter on appeal:
1. A medical device having an interior for containment of fluids;
an access site having an opening into the access site interior, said
access site defining an annular, outer end surface surrounding said opening,
and an elastomeric wall sealingly bonded to said annular, outer end surface
at an inner face of said elastomeric wall, said elastomeric wall having a
radially outwardly facing peripheral surface which is essentially spaced from
said access site, said elastomeric wall comprising a disk which is free of
longitudinally inwardly extending projections used to secure said
elastomeric wall to the medical device.

The Examiner relies on the following evidence:
Jepson US 6,261,282 B1 Jul. 17, 2001

The Examiner rejected the claims under 35 U.S.C. § 102(b) as
anticipated by Jepson.
We reverse.
ISSUE
Claims 1, 14, and 20, the only independent claims, include a proviso
that the elastomeric wall of the device comprises a disk, free of
longitudinally inwardly extending projections used to secure the elastomeric
wall to the device.
Appellant contends that Jepson’s device includes a longitudinally
inwardly extending projection that secures the elastomeric wall to the
device, and is therefore outside the scope of the claims (App. Br. 10).
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The Examiner finds that Jepson’s device includes a longitudinally
extending projection that secures an elastomeric wall to the device, but the
projection is not inwardly extending, and is therefore not excluded by the
claims (Ans. 7).
The issue raised by this rejection on appeal is whether Appellant has
established that the Examiner erred in finding that the elastomeric wall of
Jepson’s device is free of longitudinally inwardly extending projections used
to secure the elastomeric wall to the device, which in turn, depends on the
interpretation of the term “inwardly extending.”
FINDINGS OF FACT
FF1 Appellant claims a medical device with an interior for
containing fluids. The device has an access site with an opening to the
interior. The opening of the access site is surrounded by an annular, outer
end surface, and an elastomeric wall is sealingly bonded to the annular, outer
end surface, with the proviso “said elastomeric wall comprising a disk which
is free of longitudinally inwardly extending projections used to secure said
elastomeric wall to the medical device” (claim 1).
FF2 As explained in the Specification, the elastomeric wall can be
molded (Spec. 12), but is preferably “mass produced from appropriate
elastomer sheeting by a process of punching out the discs of elastomer. . . for
a significant saving of manufacturing costs over molded, elastomeric walls”
(id. at 14). “[S]uch an elastomeric wall . . . lacks long projections, skirts, or
appendages which extend downwardly into [the] bore portion . . . [of the
device], or outside thereof, and are used to retain [the] elastomeric wall”
(id.).
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Application 11/081,484

FF3 Figure 1a of the Specification, a portion of which is reproduced
below, illustrates an embodiment of the invention where elastomeric wall 20
is punched from a sheet of elastomer:

This portion of Figure 1a depicts medical device 10, “having an end which is
terminated in injection or access site 14” (id. at 10). “An elastomeric wall
20 is provided, which has a slit or perforation 22 to comprise a fixedly
placed, flexible barrier across opening 21” (id. at 11). “Elastomeric wall 20
is laterally secured at its periphery 24 at an end of housing 14 . . . [and] outer
face 25 of elastomeric wall 20 is exposed to the exterior for access from
lateral directions . . . to clean [the] outer surface” (id.).
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FF4 Figure 2 of the Specification, reproduced below, illustrates
another embodiment of the invention where elastomeric wall 20a is punched
from a sheet of elastomer:

Figure 2 of the Specification depicts an embodiment “which is similar to the
system of Fig. 1a, in which . . . perforated elastomeric wall 20a is attached at
its periphery 24a to access site 14a, but only at the side thereof, and not at
. . . radially outwardly facing, actual periphery 24a (id. at 12-13). Rather, a
“peripheral portion of the inner face of an elastomeric wall 20a, opposite to
outer surface 25a, is bonded . . . [to] access site 14a” (id. at 13).
FF5 Jepson describes a device comprising a “connector utilizing a
resealable valve having an opening extending through at least a portion of
the valve” (Jepson, col. 6, ll. 48-50). “The valve is resiliently restrained
relative to a housing with the valve and housing configured to accept a
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Application 11/081,484

penetrating member having a tip [e.g., a male luer tip] which penetrates the
valve through the opening” (id. at col. 6, ll. 50-53).
FF6 “[T]he resealable valve is a septum” (Jepson, col. 6, ll. 57-58),
“formed of a[n] elastic, resilient material” (id. at col. 11, ll. 11-12).
FF7 “[T]he septum includes . . . [a] generally disk shaped upper
portion covering an opening defined by the housing” (Jepson, col. 6, ll. 59-
61). “The upper portion of the valve is resiliently retained relative to the
housing by integral attachment with an annular skirt” (id. at col. 6, ll. 65-67).
“[T]he skirt may be attached to the interior surface of the housing in a first
embodiment and surrounding and attached to an exterior surface of the
housing in a second embodiment” (id. at col. 6. l. 67 to col. 7, l. 2).
FF8 Figure 4 of Jepson, a portion of which is reproduced below,
illustrates the second embodiment of Jepson’s device, wherein the upper
portion of the valve is resiliently retained on the housing by an annular skirt
that surrounds and attaches to the exterior of the housing:

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Application 11/081,484

This portion of Figure 4 is a sectional view of the second embodiment of
Jepson’s device showing valve member 104 which “includes an annular skirt
portion 108 which extends about and surrounds an upper portion 110 of the
housing 102 adjacent the upper end 106. Preferably the skirt 108 is bonded
to the exterior surface 112” (id. at col. 11, l. 67 to col. 12, l. 3).
FF9 The Examiner finds that the embodiment of Jepson illustrated
in Figure 4 is free of longitudinally inwardly extending projections used to
secure the elastomeric wall to the device, and therefore does not violate the
proviso of claim 1. Specifically, the Examiner finds that “[p]rojection 46/44
is longitudinally inwardly extending, but is not used to secure the
elastomeric wall to the luer connector” (Ans. 7), while projection 108 is
longitudinally extending, and is used to secure the elastomeric wall to the
connector, but it is “outwardly” (id.), rather than inwardly extending.
PRINCIPLES OF LAW
“To anticipate a claim, a prior art reference must disclose every
limitation of the claimed invention, either explicitly or inherently.” In re
Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997).
During examination, the PTO must interpret terms in a claim using
“the broadest reasonable meaning of the words in their ordinary usage as
they would be understood by one of ordinary skill in the art, taking into
account whatever enlightenment by way of definitions or otherwise that may
be afforded by the written description contained in the applicant’s
specification.” In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997).
In addition, “[t]he ordinary and customary meaning of a claim term
may be determined by reviewing a variety of sources. Some of these
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sources include the claims themselves; dictionaries and treatises; and the
written description, the drawings, and the prosecution history.” Brookhill-
Wilk 1, LLC v. Intuitive Surgical, Inc., 334 F.3d 1294, 1298 (Fed. Cir. 2003)
(citations omitted).
ANALYSIS
Independent claims 1, 14, and 20 include the proviso that the
elastomeric wall of the device comprises a disk, free of longitudinally
inwardly extending projections used to secure the elastomeric wall to the
device.
The Examiner’s position is that the embodiment of Jepson illustrated
in Figure 4 is free of longitudinally inwardly extending projections used to
secure the elastomeric wall to the device, and therefore does not violate the
proviso of the claims. Specifically, the Examiner concedes that projection
108 is longitudinally extending, and is used to secure the elastomeric wall to
the connector, but contends that it is outwardly, rather than inwardly
extending (Ans. 7).
Appellant contends that the term “longitudinally inwardly extending”
means: in the direction from the end surface to which the elastomeric wall is
secured toward the device itself along the longitudinal axis of the device
(App. Br. 10). Appellant contends that annular skirt 108 of Jepson’s valve
member 104, even though attached to the exterior of the device, extends
longitudinally inwardly because it extends from the end to which valve
member 104 is attached toward the device itself, rather than projecting away
from the end.
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Application 11/081,484

Appellant has the better argument. According to the Examiner, her
interpretation of “inwardly” and “outwardly” is based on “surface 24a[ ] in
appellant’s Fig. 2” (Ans. 5) which is described in the present Specification
as a “radially outwardly facing . . . periphery” (Spec. 13). The Examiner’s
interpretation of Figure 2 of the present Specification is shown below, as
annotated by the Examiner (Ans. 6):

Annotated Figure 2 of the Specification shows the Examiner’s interpretation
of “inwardly” and “outwardly” extending. The Examiner reasons, “[b]ased
on the direction outside from the luer lock being identified as ‘outward,’ one
of ordinary skill in the art would interpret the opposite direction to be
‘inward,’ or to the inside of the luer lock” (Ans. 5). Thus, the Examiner
interprets the “inwardly extending” proviso to exclude projections attached
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Application 11/081,484

to the interior of the device, but not projections attached to the exterior of the
device.
The Examiner’s interpretation makes sense for the outward and
inward directions along the lateral/radial axis of the device. In that case, we
agree that “inwardly” would be towards the interior of the device along an
axis perpendicular to the longitudinal axis, i.e., 180º from “radially
outwardly.” However, the claim requires the device to be free of
longitudinally inwardly extending projections. The Specification describes
elastomeric wall 20a in Figure 2 as having an “inner face . . . opposite to
outer surface 25a” (FF4). Thus, with respect to the longitudinal axis of the
device, it is reasonable to interpret “outwardly” as the vector extending from
the elastomeric wall away from the device along the longitudinal axis, and
“inwardly” as 180º from that, i.e., the vector extending from the elastomeric
wall toward the device along the longitudinal axis.
Moreover, this interpretation is consistent with the Specification’s
teaching that punching discs out a sheet of elastomer produces elastomeric
walls that “lack[ ] long projections, skirts, or appendages which extend
downwardly into [the] bore portion . . . [of the device], or outside thereof,
and are used to retain [the] elastomeric wall” (FF2).
We agree with Appellant that the Examiner has not established that
the term “longitudinally inwardly extending” excludes projections attached
to the exterior of the device.

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CONCLUSIONS OF LAW
Appellant has established that the Examiner erred in finding that the
elastomeric wall of Jepson’s device is free of longitudinally inwardly extending
projections used to secure the elastomeric wall to the device.
Accordingly, the rejection of claims 1-12 and 14-24 under 35 U.S.C. §
102(b) is reversed, as the Examiner has not established that Jepson’s device
meets all the limitations of the claims on appeal.

REVERSED

Ssc:

SEYFARTH SHAW LLP
131 S. DEARBORN ST., SUITE 2400
CHICAGO, IL 60603-5803
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