Ex Parte Zawacki et al

Patent Trial and Appeal Board

Dec 21, 2012

11874447 (P.T.A.B. Dec. 21, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte JOHN A. ZAWACKI, KELLY B. POWERS, JOHN G. EVANS,
and GUY ROME
__________

Appeal 2011-000301
Application 11/874,447
Technology Center 3700
__________

Before TONI R. SCHEINER, JACQUELINE WRIGHT BONILLA, and
ULRIKE W. JENKS, Administrative Patent Judges.

BONILLA, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims directed to a
multi-lumen catheter comprising two tip sections. The Examiner has
rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.

Appeal 2011-000301
Application 11/874,447

2
STATEMENT OF THE CASE
The Specification describes a multi-lumen catheter having a plurality
of separate distal tips, such as a split-tip catheter (Spec. [0002]). The
Specification states that a “tip section” of such a catheter refers to a section
“enclosing at least one lumen, which is separable or is separated from
another tip section along its length distal to a dividing point” (id. at [0012])
Claims 1-7 are on appeal. Independent claim 1 is representative and
reads as follows:
1. A multi-lumen catheter, comprising:
a generally cylindrical body enclosing a first and second lumen
separated by a generally planar septum;
a first tip section extending from a distal end of the body
including a generally planar surface extending from the septum and an
opening in a distal end surface oblique to the planar surface; and
a second tip section including a first segment with a first cross-
sectional area extending from the distal end of the catheter body to a
transition segment and a second segment with a second cross-
sectional area greater than the first cross-sectional area extending
from the transition segment to a distal end of the second tip section.
Claims 1, 2, and 4-7 stand rejected under 35 U.S.C. § 103(a) as
obvious over Ash et al. (US 6,190,349 B1, issued Feb. 20, 2001) in view of
Quinn (US 2002/0026156 A1, published Feb. 28, 2002) (Ans. 3-6). Claim 3
stands rejected under 35 U.S.C. § 103(a) as obvious over Ash in view of
Quinn, further in view of Bacich et al. (US 4,990,138, issued Feb. 5, 1991)
(Ans. 6).
App
App

1.
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/874,447
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2.
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ar septum
Ash pres
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(Ash, col.
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/874,447
in the Spe
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Appeal 2011-000301
Application 11/874,447

5
assembly in a partially split state (id. at col. 4, ll. 2-4). Figure 4A depicts an
enlarged cross-sectional view of the multiple catheter assembly of Figure 1,
taken along line 4-4 (id. at ll. 8-10).
5. Referring to Figure 4A, Ash describes that “catheter assembly 10
includes a splittable membrane 46 which extends longitudinally between and
joins the opposite generally flat side surfaces 38, 44 of the first and second
catheters 26, 30” (id. at col. 6, ll. 30-33).
6. Ash further describes that “the membrane 46 allows the first and
second catheters 26, 30 to be at least partially longitudinally split apart from
each other, as shown in FIG. 3, without damaging the outer surfaces 34, 40
of either of the first or second catheters 26, 30…” (id. at ll. 45-51).
Analysis
Independent claims 1 and 7 each recite a multi-lumen catheter
comprising, inter alia, “a generally cylindrical body enclosing a first and
second lumen separated by a generally planar septum” (claim 1) (emphasis
added). “[D]uring examination proceedings, claims are given their broadest
reasonable interpretation consistent with the specification.” In re Hyatt, 211
F.3d 1367, 1372 (Fed. Cir. 2000).
The Specification does not define “septum” per se, but describes a
“catheter 10” that “has two lumens defined by an outer wall 16 and a
bisecting planar septum 18,” as shown in Figure 1 (Spec. [0060]; FF 1). The
Specification also refers to a “catheter tube 114” that “encloses substantially
similar D-shaped lumens 120, 122 separated by a planar septum 118,” as
shown in Figure 8A (id. at [0069]; FF 1). The Specification also refers to a
Appeal 2011-000301
Application 11/874,447

6
“split-tip catheter 200” that has “[p]lanar surfaces 230, 232 extend[ing] from
a planar septum 228, which divides a catheter tube 214 into a pair of distinct
lumens that continue into the arterial tip section 224 and the venous tip
section 226 respectively distal to the dividing point,” as shown in Figure 12
(id. at [0086]) (see also [00109] (discussing a septum shown in Figures 22A
and 22B).
Descriptions and drawings in the Specification use the term “septum”
in a manner that is consistent with how an ordinary artisan defines (and
would have defined) the term, i.e., “a wall dividing two cavities” (FF 1-3).1
In other words, “a generally planar septum” as recited in claim 1 refers to a
generally planar wall that divides a first and second lumen in a generally
cylindrical body, such as shown in Figure 8A of the Specification (FF 1, 3).
The Examiner finds that Ash discloses a multi-lumen catheter
comprising “a generally cylindrical body (cannulating portion [20])
enclosing a first (first lumen [28]) and second lumen (second lumen [32])
separated by a generally planar septum (splittable membrane [46]),” citing
Figures 1-4A in Ash (Ans. 4). The Examiner also finds that the “generally
planar septum [46] does separate the first and second lumens [28][32] from
each other,” and concludes that claim 1 “does not require the septum to form
the first and second lumens” (id. at 7-8).

1 Taber’s Cyclopedic Medical Dictionary 1662 (16th ed. 1989) (defining
“septum” as a “wall dividing two cavities”); see also Septum, WIKIPEDIA,
THE FREE ENCYCLOPEDIA, http://en.wikipedia.org/wiki/Septum (last visited
Dec. 18, 2012) (defining “septum” as “a wall, dividing a cavity or structure
into smaller ones”); see also Reply Br. 3 (referring to a similar definition of
“septum”).
Appeal 2011-000301
Application 11/874,447

7
Such findings and conclusion regarding “splittable membrane [46]” in
Ash ignore the plain meaning of the term “septum” as consistent with the
use of that term in the Specification. The splittable membrane (46) as shown
in Figure 4A in Ash is not a wall that divides a first and second lumen in a
generally cylindrical body. As stated by Appellants (App. Br. 8), “the
splittable membrane 46 is a thin material connecting a first and second
catheter 26 and 30 along their outer surfaces and is only a very small
fraction of the width of the catheter,” as shown in Figure 4A of Ash, relied
upon by the Examiner (Ans. 4, 7-8). The Examiner does not assert or
explain how membrane 46 in Ash corresponds to, or renders obvious, a
septum, i.e., a wall dividing two lumens.
Because the Examiner does not establish how Ash (or Quinn)
discloses or suggests a catheter comprising “a generally cylindrical body
enclosing a first and second lumen separated by a generally planar septum,”
as recited in claims 1 and 7, the Examiner fails to present a prima facie case
of obviousness of these two independent claims, as well as claims 2 and 4-6,
which depend on claim 1. Because the Examiner fails to establish a prima
facie case of unpatentability in the first instance, the obviousness rejection of
claims 1, 2, and 4-7 must be reversed. In re Oetiker, 977 F.2d 1443, 1445
(Fed. Cir. 1992); In re Rijckaert, 9 F.3d 1531, 1532 (Fed. Cir. 1993).
II.
The Examiner rejects claim 3, which depends on claim 1, as obvious
over Ash in view of Quinn, in further view of Bacich (Ans. 6). The
Examiner relies on Quinn as teaching a second tip section as recited in claim
1 (Ans. 4-5). The Examiner relies on Bacich as teaching the distal end of the
Appeal 2011-000301
Application 11/874,447

8
second tip section as recited in dependent claim 3 (id. at 6). The Examiner
does not rely on Quinn or Bacich for the teaching of “a generally planar
septum” as recited in claim 1, but instead relies on Ash as disclosing this
element (id. at 4, 7). Thus, for the same reasons discussed above, the
Examiner fails to establish a prima facie case of obviousness of claim 3.
SUMMARY
We reverse the rejection of claims 1, 2, and 4-7 as obvious over Ash
in view of Quinn. We also reverse the rejection of claim 3 as obvious over
Ash in view of Quinn, further in view of Bacich.

REVERSED

cdc

Notice of References Cited

Application/Control No.

11/874,447
Applicant(s)/Patent Under
Reexamination
John A. Zawacki
Examiner

Shefali Patel
Art Unit

3700

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Taber’s Cyclopedic Medical Dictionary 1662 (16th ed. 1989) (defining “septum” as a
“wall dividing two cavities”).

V

Septum, WIKIPEDIA, THE FREE ENCYCLOPEDIA, http://en.wikipedia.org/wiki/Septum (last
visited Dec. 18, 2012) (defining “septum” as “a wall, dividing a cavity or structure into
smaller ones”).

W

X

*A copy of this reference is not being furnished with this Office action. (See Manual of Patent Examining Procedure, Section 707.05(a).)
**APS encompasses any electronic search i.e. text, image, and Commercial Databases.
U.S. Patent and Trademark Office

Septum 1
Septum
In anatomy, a septum (Latin for something that encloses; plural septa) is a wall, dividing a cavity or structure into
smaller ones.
Examples
In human anatomy
• Interatrial septum, the wall of tissue that is a sectional part of the left and right atria of the heart
• Interventricular septum or median septum, the wall separating the left and right ventricles of the heart
• Lingual septum, a vertical layer of fibrous tissue that separates the halves of the tongue
• Nasal septum: the cartilage wall separating the nostrils of the nose
Alveolar septa (AS)
• Alveolar septum: the thin wall which
separates the alveoli from each other in
the lungs
• Orbital septum, a palpabral ligament in
the upper and lower eyelids
• Septum pellucidum or septum lucidum, a
thin structure separating two fluid
pockets in the brain
• Medial septum, a cluster of neurons in
close proximity to the septum pellucidum
• Uterine septum, a malformation of the
uterus
• Vaginal septum, a lateral or transverse
partition inside the vagina
Histological septa are seen throughout most
tissues of the body, particularly where they
are needed to stiffen soft cellular tissue, and they also provide planes of ingress for small blood vessels. Because the
dense collagen fibres of a septum usually extend out into the softer adjacent tissues, microscopic fibrous septa are
less clearly defined than the macroscopic types of septa listed above. In rare instances, a septum is a cross-wall.Thus
it divides a structure into smaller parts.
In zoology
• One of the radial calcareous plates of a coral. b. One of the transverse partitions dividing the shell of a mollusk, or
of a rhizopod, into several chambers. c. One of the transverse partitions dividing the body cavity of an annelid.
• Septum (marine biology): walls between each chamber, or siphuncle, in shells of nautiloids, ammonites, and
belemnites; i.e. cephalopods that retain an external shell.
In mycology
• A partition dividing filamentous hyphae into discrete cells in fungi
Septum 2
In botany
• A partition that separates the locules of a fruit, anther, or sporangium.
Article Sources and Contributors 3
Article Sources and Contributors
Septum  Source: http://en.wikipedia.org/w/index.php?oldid=527198353  Contributors: AEMoreira042281, Adrian J. Hunter, Alex.muller, Anthony Appleyard, Arcadian, AxelBoldt, BillC, Can't
sleep, clown will eat me, CanisRufus, Carcharoth, Cliffb, CopperKettle, Cybercobra, DaGizza, Danger, DanielCD, DeadEyeArrow, DerekWinters, Dlatrex, Dmarquard, Doctor Ruud, Double
Dickel, Drbreznjev, Drivenapart, EdH, Ekem, Esperant, Fresheneesz, Func, Heliocybe, Hello71, Ian Page, Ieremias, Interiot, JHunterJ, Jeffrey Mall, Jfurr1981, Just James, Kaarel, Kate,
Knowledge Seeker, Loggie, Majicpowers, Marnanel, Martin451, Milton Stanley, Mind the gap, Monty845, My76Strat, Nadiatalent, Ouedbirdwatcher, Postdlf, Radagast83, Rhd, Rifleman 82,
Rjwilmsi, Runehelmet, SJP, Sadi Carnot, Scohoust, Sgarbern, Usgnus, UtherSRG, Variant13, Wickey-nl, Zana Dark, 77 anonymous edits
Image Sources, Licenses and Contributors
File:Bronchial anatomy with description.png  Source: http://en.wikipedia.org/w/index.php?title=File:Bronchial_anatomy_with_description.png  License: Creative Commons Attribution 2.5
 Contributors: Patrick J. Lynch, medical illustrator, modified by Christian2003
License
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