Ex Parte Lentz et al

Patent Trial and Appeal Board

Feb 24, 2015

12714589 (P.T.A.B. Feb. 24, 2015)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
12/714,589 03/01/2010 David Christian Lentz PA-6758-RFB 7069
90981 7590 02/25/2015
Cook Medical Technologies LLC
c/o Liell & McNeil Attorneys PC
P.O. Box 2417
511 S. Madison Street
Bloomington, IN 47402
EXAMINER
VU, QUYNH-NHU HOANG
ART UNIT PAPER NUMBER
3763
MAIL DATE DELIVERY MODE
02/25/2015 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte DAVID CHRISTIAN LENTZ
and DAVID A. DREWES, JR.
1

__________

Appeal 2012-008192
Application 12/714,589
Technology Center 3700
__________

Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and
AMANDA F. WIEKER, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
catheter, which have been rejected as obvious. We have jurisdiction under
35 U.S.C. § 6(b).
We reverse.

1
According to Appellants, the Real Party in Interest is Cook Medical
Technologies LLC (Appeal Br. 2).
Appeal 2012-008192
Application 12/714,589

2
STATEMENT OF THE CASE
The Specification states that guide catheters have a composite
construction: an “inner tube typically compris[ing] a lubricious material
such as polytetrafluoroethylene (PTFE)” and an outer tube “typically formed
from a polyether-block amide material . . . or another equivalent material”
(Spec. 1 ¶ 3). “PTFE is known to be difficult to manage relative to standard
thermoplastics in a continuous non-batch extrusion type process” (id. at 2
¶ 3). But “thermoplastics tend to present a substantially higher co-efficient
of friction than that associated with PTFE. Thus, common thermoplastics
are generally not considered suitable for defining the inner lumen of guide
catheters . . . that must allow other devices to be easily slid through the inner
lumen.” (Id. at 2 ¶ 4.)
The Specification discloses a catheter that “comprises a mixture,
which includes thermoplastic and beads, defining a first tube with an inner
goose bump surface” (id. at 2 ¶ 6). “[I]t is believed that the goose bump
surface provides such a dramatic reduction in contact area between the
reinforced catheter . . . and another medical device slid therethrough, such as
balloon catheter, that the goose bump surface produces apparent low friction
results comparable to PTFE” (id. at 5 ¶ 15, reference numbers omitted).
Claims 1–13, 20, and 21 are on appeal. Claim 1 is illustrative and
reads as follows:
1. A reinforced catheter or sheath comprising:
a mixture, which includes thermoplastic and beads, defining a first
tube with an inner goosebump surface defined by the thermoplastic and an
outer surface, and the inner goosebump surface includes randomly
distributed rounded protuberances rising out of a smooth base surface, and
the beads are encased in the thermoplastic;
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Application 12/714,589

3
a reinforcement attached to at least a segment of the outer surface;
a second tube covering at least a portion of the reinforcement; and
wherein the inner goosebump surface reduces a contact area between
the thermoplastic of the first tube and another medical device slid
therethrough to produce an apparent low friction.

Claim 20, the only other independent claim, also requires “a
reinforced catheter or sheath with a lumen defined by a goosebump surface
of thermoplastic.”
The claims stand rejected under 35 U.S.C. § 103(a) as follows:
Claims 1, 2, and 4–7 based on Wilson
2
and Ren
3
(Ans. 4);
Claim 8 based on Wilson, Ren, and Dave
4
(Ans. 8);
Claims 1–7, 9–12, and 21 based on Wilson and Buck
5
(Ans. 6);
Claims 8 and 13 based on Wilson, Buck, and Dave (Ans. 8); and
Claim 20 based on Pepin
6
and either of Ren or Buck (Ans. 9).
I.
The Examiner has rejected claims 1, 2, and 4–7 as obvious based on
Wilson and Ren, and has rejected claim 8 as obvious based on Wilson, Ren,
and Dave. The same issue is dispositive for both rejections.
The Examiner finds that Wilson discloses a catheter having an inner
tube, a reinforcement, and an outer tube (Ans. 4) and that Ren discloses a
“tube [ ] extruded from a mixture having a thermoplastic polymer, hard
particles, lubricating particles and external lubricant” (id.). The Examiner

2
Wilson, US 6,197,015 B1, issued Mar. 6, 2001.
3
Ren, US 6,086,970, issued July 11, 2000.
4
Dave, US 2007/0202150 A1, published Aug. 30, 2007.
5
Buck et al., US 4,925,710, issued May 15, 1990.
6
Pepin et al., US 5,531,721, issued July 2, 1996.
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Application 12/714,589

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concludes that it would have been obvious to “modify the device of Wilson
with a mixture of thermoplastic with beads and uneven surface, as taught by
Ren, for the benefits of improving strength, lubricity and reducing the
sliding friction of the two surfaces” (id. at 5).
Appellants argue that “Ren teaches a thermoplastic tube that includes
glass beads and is formed into a tube that is coated with a lubricant film”
(Appeal Br. 9) but “the claims require the goosebump surface to be defined
by thermoplastic, not some other thing, such as a lubricant coating” (id.).
That is, “if the modification included the lubricant coating taught by Ren as
being necessary for sliding capability, the resultant combination would be
something other than what Applicants have claimed. In other words,
Applicants’ claims require that the inner tube surface be defined by
thermoplastic not a lubricant coating.” (Id.)
We agree with Appellants that the Examiner has not shown that the
cited references would have made obvious a catheter or sheath having “an
inner goosebump surface defined by [a] thermoplastic,” as required by the
claims. The rejection is based on replacing the inner tube of Wilson’s
device with a tube made from the mixture taught by Ren (Ans. 5).
Ren’s mixture comprises a thermoplastic and hard particles (Ren
2:52–54) as well as lubricating particles and an external lubricant (id.). Ren
states that the “[e]xternal lubricants tend to migrate strongly to the tube
surfaces, and to form or release a uniform invisible film over the surfaces”
(id. at 4:2–4). “The external lubricant is believed to form a film over the
polyamide and lubricating particles. In particular, the external lubricant is
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Application 12/714,589

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believed to form a film over the PTFE particles protruding from the tube
surfaces.” (Id. at 4:25–28.)
Thus, Ren discloses that a tube made from its mixture has a film of
external lubricant on its surface, and therefore does not have an inner surface
“defined by the thermoplastic,” as required by the claims on appeal. The
Examiner did not provide any persuasive reasoning in response to
Appellants’ argument that the claim language cannot reasonably be
interpreted to read on an inner tube made from the mixture disclosed by Ren
(see Ans. 10–15). We therefore reverse the rejection of claims 1, 2, and 4–7
as obvious based on Wilson and Ren, and the rejection of claim 8 as obvious
based on Wilson, Ren, and Dave.
II.
The Examiner has rejected claims 1–7, 9–12, and 21 as obvious based
on Wilson and Buck, and has rejected claims 8 and 13 based on Wilson,
Buck, and Dave. The same issue is dispositive for both rejections.
The Examiner finds that Wilson discloses a catheter having an inner
tube, a reinforcement, and an outer tube (Ans. 6) and that “Buck discloses a
medical catheter tube comprising: an inner tube 12 including a mixture of
thermoplastic (i.e. fluoropolymer) and a filler (i.e. glass bead)” (id.). The
Examiner concludes that it would have been obvious “to modify the device
of Wilson with a mixture of thermoplastic and beads and uneven surface, as
taught by Buck, for the benefits of improving strength, lubricity and
reducing the sliding friction of the two surfaces” (id. at 6–7).
Appellants argue that their “specification makes it clear that
‘polyamides such [as] nylon and elastomers such as polyester block amide
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Application 12/714,589

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would be considered thermoplastic according to the present disclosure, but
PTFE would not’” (Appeal Br. 11).
We agree with Appellants that, when the claim language is read in
light of the Specification, the broadest reasonable interpretation of
“thermoplastic” does not include fluoropolymers such as PTFE. The
Specification states that guide catheters “typically comprise[ ] a lubricious
material such as polytetrafluoroethylene (PTFE),” which is a problem
because “PTFE is known to be difficult to manage” (Spec. 1–2 ¶ 3). The
Specification also states:
As used in the context of this disclosure, a thermoplastic is a
polymer that turns to a liquid when heated and freezes to a
glassy state when cooled, such that the material is particularly
suited to extrusion molding techniques. Thus, for instance,
polymides [sic] such as nylon and elastomers such as polyester
block amide would be considered thermoplastics according to
the present disclosure, but PTFE would not.
(Id. at 4–5 ¶ 14.)
The Examiner reasons that the claim language reads on an inner tube
comprising a fluoropolymer and a filler, as disclosed by Buck, for two
reasons. First, “the features upon which applicant relies (i.e., polyamides
such [as] nylon and elastomers such as polyester block amide would be
considered thermoplastic, but not PTFE) are not recited in the rejected claim
1” (Ans. 16). Second, Wilson and Buck do not limit the composition of their
inner tubes to PTFE alone but also disclose that other fluoropolymers can be
used as well (id.).
We conclude that the broadest reasonable interpretation of
“thermoplastic,” as recited in the claims on appeal, excludes PTFE and other
similar fluoropolymers. As Appellants point out, the Specification expressly
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excludes PTFE from its definition of “thermoplastic,” by stating that
“polymides [sic] such as nylon and elastomers such as polyester block amide
would be considered thermoplastics according to the present disclosure, but
PTFE would not” (Spec. 4–5 ¶ 14). The Specification also states that the
disclosed invention—incorporating beads into the thermoplastic used to make
the first tube of the claimed catheter or sheath—overcomes the disadvantages
of using “a lubricious material such as polytetrafluoroethylene (PTFE)”
(Spec. 1 ¶ 3, emphasis added) for that layer. We agree with Appellants,
therefore, that when the claim language is read in light of the Specification,
the term “thermoplastic” excludes not only PTFE but also other
fluoropolymers, which share its property of being “difficult to manage
relative to standard thermoplastics” (id. at 2 ¶ 3).
Consistent with that interpretation, Buck states that “[p]olytetra-
fluoroethylene and related fluoropolymers possess a unique combination of
properties” (Buck 1:10–11) that make them desirable but difficult to work
with (see id. at 1:28 to 2:10). Thus, the broadest reasonable interpretation of
the claim language, when read in light of the Specification as it would be
understood by those skilled in the art, is that “thermoplastic” excludes PTFE
and related fluoropolymers. This is true even though, as the Examiner has
pointed out (Ans. 16), the claims do not expressly state that “thermoplastic”
does not include PTFE and related fluoropolymers.
In summary, the Examiner has not established that Wilson and Buck
would have made obvious the claimed invention, when the claim language is
given its broadest reasonable interpretation consistent with the Specification.
We therefore reverse the rejection of claims 1–7, 9–12, and 21 under
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Application 12/714,589

8
35 U.S.C. § 103(a) based on Wilson and Buck. For the same reason, we
reverse the rejection of claims 8 and 13 under 35 U.S.C. § 103(a) based on
Wilson, Buck, and Dave.
III.
The Examiner has rejected claim 20 as obvious based on Pepin and
either of Ren or Buck. This rejection relies on either Ren or Buck to meet
the limitation of a catheter or sheath with “a lumen defined by a goosebump
surface of thermoplastic” (Ans. 9). For the reasons discussed above with
respect to claim 1, we conclude that neither Ren nor Buck disclose this
limitation. We therefore reverse the rejection of claim 20.
SUMMARY
We reverse all of the rejections on appeal.

REVERSED

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