Ex Parte Utterberg et al

Patent Trial and Appeal Board

Feb 25, 2013

11247931 (P.T.A.B. Feb. 25, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte DAVID S. UTTERBERG and WILLIAM J. SCHNELL
__________

Appeal 2011-002320
Application 11/247,931
Technology Center 3700
__________

Before TONI R. SCHEINER, JEFFREY N. FREDMAN, and
SHERIDAN K. SNEDDEN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a closure
for a lumen access port of a medical fluid flow line. The Examiner rejected
the claims as indefinite, as anticipated, and as obvious. We have jurisdiction
under 35 U.S.C. § 6(b). We affirm-in-part but designate the affirmance as a
new grounds of rejection.

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Statement of the Case
Background
The Specification teaches “a closure for a tubular access port in a
medical fluid flow line or other container comprises: a removable, tubular
cap for enclosing the tubular access port” (Spec. 2). According to the
Specification, the “cap has a closed end wall, with or without a male
member attached to its inner face, while typically the end wall’s outer face,
in turn, carries an outwardly extending poker” (Spec. 2).
The Claims
Claims 1-13, 21, 22, and 24-29 are on appeal. Claims 1 and 21 are
representative and read as follows:
1. A closure for a lumen-defining access port of a
medical fluid flow line or other container, which comprises:
a removable cap for enclosing and sealing said tubular
access port, said cap having a closed end wall, said end wall
carrying an extending poker to facilitate the pushing of an
antiseptic-containing material into a lumen of said access
port, the poker having an outer diameter that is less than the
inner diameter of said access port, to provide a space
therebetween along substantially all of the length of the
poker as the poker occupies said access port, said space
being substantially filled with an antiseptic-containing
material.

21. A removable cap for enclosing and sealing an access
port of a medical fluid flow line or another container, which
cap defines an attached, outwardly extending, C-shaped
projection proportioned and of a stiffness to releasably grip
medical tubing of said medical fluid flow line along
substantially all of the length of said C-shaped projection, to
permit releasable attachment of said cap to the flow line
with the cap being spaced from the access port.
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The issues
A. The Examiner rejected claim 1 under 35 U.S.C. § 112, second
paragraph as indefinite (Ans. 4).
B. The Examiner rejected claim 21 under 35 U.S.C. § 102(b) as
anticipated by Schnell
1
(Ans. 4).
C. The Examiner rejected claims 1, 3, 4, 6-9, 13, 22-25, and 27-29 under
35 U.S.C. § 103(a) as obvious over Utterberg,
2
Hiroto,
3
and Yamanaka
4

(Ans. 4-7).
D. The Examiner rejected claims 2, 11, and 12 under 35 U.S.C. § 103(a)
as obvious over Utterberg, Hiroto, Yamanaka, and Atkinson
5
(Ans. 7).
E. The Examiner rejected claims 5, 10, and 26 under 35 U.S.C. § 103(a)
as obvious over Utterberg, Hiroto, Yamanaka, and Schnell (Ans. 8).
A. 35 U.S.C. § 112, second paragraph - indefiniteness
The Examiner finds that “[c]laim 1 claims a cap for a port. The port is
not positively recited. However, Applicant claims a space that is defined by
the poker and port, making the space indefinite” (Ans. 4).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that claim 1 is indefinite?
Principles of Law
“The test for definiteness is whether one skilled in the art would
understand the bounds of the claim when read in light of the specification.”

1
Schnell, W., US 6,090,066, issued Jul. 18, 2000.
2
Utterberg, D., US 5,951,519, issued Sep. 14, 1999.
3
Hiroto, A., JP 410035716 A, published Feb. 10, 1998.
4
Yamanaka et al., US 6,468,251 B1, issued Oct. 22, 2002.
5
Atkinson et al., US 4,535,819, issued Aug. 20, 1985.
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Miles Laboratories, Inc. v. Shandon, Inc., 997 F.2d 870, 875 (Fed. Cir.
1993).
Analysis
We find that claim 1 is definite. The ordinary artisan would
understand that the port must include sufficient space to permit an extending
poker to occupy the port when there is some amount of antiseptic material
coated on the poker.
Conclusion of Law
The evidence of record does not support the Examiner’s finding that
claim 1 is indefinite.
B. 35 U.S.C. § 102(b) over Schnell
The Examiner finds that “Schnell discloses a cap 30 for sealing an
access port 24 both removable from medical tubing with a C-shaped handle
42 for clipping onto tubing or other apparatuses along the handles length to
keep the set in an orderly array during use” (Ans. 4). The Examiner finds
that the “cap 34 is releasably attached to the flow line 14 and the cap 34 is
spaced apart from the port 24” (id.).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that Schnell anticipates claim 21?
Findings of Fact
1. Schnell teaches that the device comprises “a handle 42 which
comprises a pair of convex walls 44 connected to body 18 at one end of the
walls. . . it may clip to tubing” (Schnell, col. 3, ll. 55-62).

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2. Figure 1 of Schnell is reproduced below:

“FIG. 1 is a fragmentary, perspective view of a medical fluid set comprising
flexible tubing and a first embodiment of the injection site of this invention”
(Schnell, col. 2, ll. 49-51).
3. Schnell teaches an “elastic, needle-pierceable and resealable
plug 26 of generally conventional design is retained in a recess defined by
annular wall 28, in a position to occlude aperture 24 so that a needle cannot
enter aperture 24 or lumen 23 without passing through needle pierceable
plug 26” (Schnell, col. 3, ll. 13-17).
4. Schnell teaches that the “needle penetrates plug 26 to enter into
communication with aperture 24 and lumen 23” (Schnell, col. 3, ll. 25-26).
Principles of Law
“A single prior art reference that discloses, either expressly or
inherently, each limitation of a claim invalidates that claim by anticipation.”
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Perricone v. Medicis Pharmaceutical Corp., 432 F.3d 1368, 1375 (Fed. Cir.
2005).
Analysis
We agree with Appellants that “the Schnell device is not a cap, as
required by the claim. Instead, the Schnell device is more akin to the access
port with which the cap of the present invention would be used” (App. Br.
11). That is, while Schnell clearly teaches a C-shaped projection to grip
medical tubing (FF 2), neither flange 30 nor plug 26 of Schnell can
reasonably be interpreted as functioning as a removable cap (FF 3-4).
Instead, the plug 26 functions as a port to permit entry into the tube and the
flange 30 simply prevents needle access into the line in the wrong location
(FF 3).
Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that Schnell anticipates claim 21.
C. 35 U.S.C. § 103(a) over Utterberg, Hiroto, and Yamanaka
The Examiner finds that “Utterberg discloses a removable cap 32
which encloses and seals tubular access port 14. The cap also has a closed
end wall 48” (Ans. 4). The Examiner finds that Utterberg “does not disclose
a poker with an outer diameter less than the inner diameter of the access port
nor does it teach an antiseptic containing material that fits between the poker
and wall of the access port” (id. at 5).
The Examiner finds that “Hiroto discloses such a poker 54 on a
threaded cap 52 to penetrate a closing film 55” (id.). The Examiner finds
that Yamanaka teaches to “wipe out a residual liquid, or to disinfect the
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mixing/charging port by using an alcohol-impregnated cotton, etc., easily
and reliably” (Yamanaka, col. 3, ll. 14-16). The Examiner finds it obvious
to “wipe out the port 16 with an alcohol impregnated cotton (either a pad or
swab) as taught by Yamanaka et al so as to kill and remove any residual
liquid or microbes from the port” (Ans. 5).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that Utterberg, Hiroto, and
Yamanaka render claim 1 obvious?
Findings of Fact
5. The Specification teaches that the
poker has an outer diameter that is less than the inner
diameter of the access port, to provide space in the access
port lumen for both the poker and the antiseptic-containing
material. The antiseptic containing material may comprise
fluid or gelled antiseptics, or antiseptic impregnated
materials. Any appropriate antiseptic may be used, such as
ethyl or isopropyl alcohol

(Spec. 3).
6. The Specification teaches that “the narrow space between poker
24c and the inner diameter wall of lumen 30 may be filled with a fluid
antiseptic agent 78, which may have been applied as a coating to poker 24c
immediately prior to placement into connector 12b” (Spec. 16).
7. The Specification teaches that the “above has been offered for
illustrative purposes only, and is not intended to limit the scope of the
invention of this application, which is as defined in the claims below” (Spec.
17).
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8. Utterberg teaches that the “complete, tapered socket of the
connector is in engagement with the outer surface of the tapered projection
and in contact with antiseptic, for improved internal surface sterilization”
(Utterberg, col. 2, ll. 15-20).
9. Figures 1-3 of Utterberg are reproduced below:

“FIG. 1 is a perspective view of a female luer connector and an attached
sealing cap . . . FIG. 2 is an elevational view of the tube connector and
cap . . . FIG. 3 is an elevational view of the connector and cap” (Utterberg,
col. 3, ll. 16-22).
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10. Utterberg teaches a tubular access port where “[t]ubing 12 may
be sealed into bore 14 of connector 10, which is typically cylindrical and not
tapered” (Utterberg, col. 3, ll. 38-40).
11. Utterberg teaches that “cap 32 and tether 34 may be added as a
separate part. Cap 32 is tethered in adjacent relation with female luer
connector 10, being capable of entering into closing relation therewith”
(Utterberg, col. 3, ll. 57-60).
12. Utterberg teaches that “[c]ap 32 comprises a cap body 36, and a
tapered projection 38, which is proportioned to sealingly fit within tapered
socket 16” (Utterberg, col. 3, ll. 61-63).
13. Utterberg teaches that “the projection preferably has an outer
surface that carries an antiseptic material, typically a volatile antiseptic
material such as povidone iodine or alcohol” (Utterberg, col. 2, ll. 13-15).
14. Utterberg teaches that “[t]apered projection 38 may have an
outer surface 40 which is coated with an antiseptic, for example by coating
with a volatile antiseptic such as povidone iodine or alcohol immediately
prior to closure” (Utterberg, col. 4, ll. 2-6).
15. Figure 5 of Hiroto is reproduced below:

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The Examiner explains that Hiroto discloses a poker with an outer diameter
less than the inner diameter of the access port teaching “such a poker 54 on a
threaded cap 52 to penetrate a closing film 55” (Ans. 5).
16. Yamanaka teaches that
it is preferable in the mixing/charging port for medical
treatment of the present invention that the cover further has
a gentle taper on the front surface side. Providing a taper
makes it possible to induce the insertion member, for
example, a luer, etc. into a fitting hole easily, as well as to
wipe out a residual liquid, or to disinfect the
mixing/charging port by using an alcohol-impregnated
cotton, etc., easily and reliably.

(Yamanaka, col. 3, ll. 9-16.)
Principles of Law
“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). “If a person of
ordinary skill can implement a predictable variation, § 103 likely bars its
patentability.” Id. at 417.
Analysis
Claim interpretation is at the heart of patent examination because
before a claim is properly interpreted, its scope cannot be compared to the
prior art. In this case, we find that both Apellants and the Examiner
incorrectly interpreted the claim phrase “the poker having an outer
diameter that is less than the inner diameter of said access port, to provide a
space therebetween along substantially all of the length of the poker as the
poker occupies said access port” in claim 1.
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During prosecution, claim terms are given their broadest reasonable
interpretation as they would be understood by persons of ordinary skill in the
art in the light of the Specification. Therefore, we first turn to the
Specification to interpret the phrase “the poker having an outer diameter that
is less than the inner diameter of said access port, to provide a space
therebetween along substantially all of the length of the poker as the poker
occupies said access port.”
The Specification teaches that the “poker has an outer diameter that is
less than the inner diameter of the access port, to provide space in the access
port lumen for both the poker and the antiseptic-containing material” (Spec.
3; FF 5). Neither claim 1 nor the Specification impose any specific
numerical values on how much space is required between the outer diameter
of the poker relative to the inner diameter of the access port, other than the
functional requirement to permit a coating of antiseptic material (FF 5-6).
We recognize that the Examiner, in response to Appellants’
amendment on June 11, 2008, accepted the Appellants’ interpretation of this
phrase to exclude the relationship of the poker 38 to port 16 of Utterberg
from satisfying the requirement for “a space therebetween along
substantially all of the length of the poker” since Utterberg teaches “that the
complete, tapered socket of the connector is in engagement with the outer
surface of the tapered projection and in contact with antiseptic, for improved
internal surface sterilization” (Utterberg, col. 2, ll. 15-20; FF 8).
We do not agree, however, that this limitation excludes Utterberg’s
poker 38 and port 16. In order for Utterberg’s poker 38 to fully penetrate the
port 16, the outer diameter of poker 38 is necessarily and inherently smaller
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in diameter than the inner diameter of port 16. Even the phrase from column
2 of Utterberg “engagement with the outer surface . . . and in contact with
antiseptic” teaches that the outer diameter of poker 38 is sufficiently smaller
than the port 16 to permit contact with antiseptic as well as the poker 38 (FF
8). As Utterberg teaches, “tapered projection 38 . . . is proportioned to
sealingly fit within tapered socket 16” (Utterberg, col. 3, ll. 61-63; FF 12).
In addition, Utterberg teaches the functional limitation required by the
Specification that the projection is coated with antiseptic material (FF 5-6),
specifically teaching that “[t]apered projection 38 may have an outer surface
40 which is coated with an antiseptic, for example by coating with a volatile
antiseptic such as povidone iodine or alcohol immediately prior to closure”
(Utterberg, col. 4, ll. 2-6; FF 14).
We therefore find that Utterberg suggests the elements of claim 1.
Specifically, Utterberg teaches a removable cap 32 for enclosing a sealing a
tubular access port 10 (FF 10). Utterberg teaches that the cap has a closed
end wall body 36 (FF 9) with a poker 38 which may be coated with
antiseptic material that is pushed into lumen 16 of port 10 (FF 9-14). The
poker 38 inherently comprises an outer diameter less than the inner diameter
of the socket 16 (FF 12) and inherently provides some amount of space,
however small, along the poker length which is filled with the antiseptic
material coated onto the outer surface 40 of poker 38 (FF 14).
We further find that Yamanaka teaches that the use of a taper, such as
that of Utterberg (FF 12) “makes it possible to induce the insertion member,
for example, a luer, etc. into a fitting hole easily, as well as to wipe out a
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residual liquid, or to disinfect the mixing/charging port by using an alcohol-
impregnated cotton” (Yamanaka, col. 3, ll. 12-15; FF 16).
Thus, consistent with the reasoning in KSR that combinations of
ordinary elements in predictable ways is likely obvious, the artisan of
ordinary skill would have been motivated to disinfect the port of a luer using
a tapered insertion member where the insertion member is coated with
alcohol or another antiseptic and is inherently smaller in diameter than the
inner diameter of the port (FF 8-14, 16).
Currently, all of the evidence of record reasonably supports our
finding that the outer diameter of poker 38 is necessarily and inherently
smaller in diameter than the inner diameter of port 16, in light of the
teaching by Utterberg that the poker fully enters port 16 while coated with
antiseptic as discussed above (FF 5-14).
Because our reasoning substantially differs from that of the Examiner,
we will designate this rejection as a New Grounds of Rejection, in order to
provide Appellants an opportunity to respond.
Conclusion of Law
The evidence of record supports the conclusion that Utterberg, Hiroto,
and Yamanaka render claim 1 obvious.
D. 35 U.S.C. § 103(a) over Utterberg, Hiroto, Yamanaka, and Atkinson
Appellants do not separately argue the rejection over Utterberg,
Hiroto, Yamanaka, and Atkinson. We therefore summarily affirm the
rejection of claims 2, 11, 12 over Utterberg, Hiroto, Yamanaka, and
Atkinson. See Manual of Patent Examining Procedure § 1205.02 (“If a
ground of rejection stated by the examiner is not addressed in the appellant's
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brief, that ground of rejection will be summarily sustained by the Board.”);
See also In re Berger, 279 F.3d 975, 984 (Fed. Cir. 2002) (in which the
Board affirmed an uncontested rejection of claims under 35 U.S.C. 112,
second paragraph, and on appeal the Federal Circuit affirmed the Board's
decision and found that the appellant had waived his right to contest the
indefiniteness rejection by not presenting arguments as to error in the
rejection on appeal to the Board).
E. 35 U.S.C. § 103(a) over Utterberg, Hiroto, Yamanaka, and Schnell
Appellants contend that the rejection “fails to address why it would be
obvious to utilize a C-shaped structure generally used to permanently secure
with and form an access port on medical tubing as a combination with a cap
for closing a medical access port, yet allowing removal and releasable
attachment elsewhere” (App. Br. 12).
We are not persuaded. The Examiner finds it obvious “to modify
Utterberg to include the c-shaped handle of Schnell for clipping onto tubing
to keep the device organized when used with other apparatuses” (Ans. 8).
We agree with the Examiner that the addition of Schnell’s clip (FF 1) to
Utterberg’s cap (FF 7-13) would reasonably allow the ordinary artisan to
keep multiple tubes together and organized when treating patients with
multiple different solutions.
SUMMARY
In summary, we reverse the rejection of claim 1 under 35 U.S.C. §
112, second paragraph as indefinite.
We reverse the rejection of claim 21 under 35 U.S.C. § 102(b) as
anticipated by Schnell.
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We affirm the rejection of claim 1 under 35 U.S.C. § 103(a) as
obvious over Utterberg, Hiroto, and Yamanaka. Pursuant to 37 C.F.R. §
41.37(c)(1), we also affirm the rejection of claims 3, 4, 6-9, 13, 22-25, and
27-29 as these claims were not argued separately.
We affirm the rejection of claims 2, 11, and 12 under 35 U.S.C. §
103(a) as obvious over Utterberg, Hiroto, Yamanaka, and Atkinson.
We affirm the rejection of claims 5, 10, and 26 under 35 U.S.C. §
103(a) as obvious over Utterberg, Hiroto, Yamanaka, and Schnell.

Because our reasoning differs from that of the Examiner, we designate
the rejections incorporating Utterberg, Hiroto, and Yamanaka as new
grounds of rejection pursuant to 37 C.F.R. § 41.50(b) (effective September
13, 2004, 69 Fed. Reg. 49960 (August 12, 2004), 1286 Off. Gaz. Pat. Office
21 (September 7, 2004)). 37 C.F.R. § 41.50(b) provides “[a] new ground of
rejection pursuant to this paragraph shall not be considered final for judicial
review.”
37 C.F.R. § 41.50(b) also provides that the Appellants, WITHIN
TWO MONTHS FROM THE DATE OF THE DECISION, must exercise
one of the following two options with respect to the new ground of rejection
to avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate amendment of the
claims so rejected or new evidence relating to the claims so rejected, or both,
and have the matter reconsidered by the Examiner, in which event the
proceeding will be remanded to the Examiner.…
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(2) Request rehearing. Request that the proceeding be reheard under §
41.52 by the Board upon the same record…

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-IN-PART, 37 C.F.R. § 41.50(b)

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