Ex Parte 7,247,150 et al

Board of Patent Appeals and Interferences

Sep 3, 2010

90010211 (B.P.A.I. Sep. 3, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte VENETEC INTERNATIONAL, INC.
(a subsidiary of C.R. BARD, INC.),
Appellant
____________

Appeal 2010-007390
Reexamination Control 90/010,211
Patent 7,247,150 B2
Technology Center 3900
____________

Before ROMULO H. DELMENDO, RICHARD M. LEBOVITZ, and
JEFFREY B. ROBERTSON, Administrative Patent Judges.

DELMENDO, Administrative Patent Judge.

DECISION ON APPEAL1

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
shown on the PTOL-90A cover letter attached to this decision.
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Reexamination Control 90/010,211
Patent 7,247,150 B2

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The Patent Owner, Venetec International, Inc. (a subsidiary of C.R.
Bard, Inc.), appeals under 35 U.S.C. §§ 134(b) and 306 from a final rejection
of claims 1, 31, and 35, which are the only claims subject to reexamination
of United States Patent 7,247,150 B2 (hereinafter “‘150 Patent”) (Appeal
Brief filed November 30, 2009, hereinafter “App. Br.,” as revised on July
16, 2010, at 3; Final Office Action mailed May 11, 2009). We have
jurisdiction under 35 U.S.C. §§ 134(b) and 306.
We heard oral arguments on August 11, 2010, a written transcript of
which will be entered into the electronic record in due course.
We AFFIRM.

STATEMENT OF THE CASE
The current proceeding arose from a third-party request for ex parte
reexamination filed by Nexus Medical LLC (“Nexus”) (Request for Ex
Parte Reexamination filed June 27, 2008). We have been informed that the
‘150 Patent is one of three related patents2 asserted against Nexus in a civil
case captioned Venetec International, Inc. v. Nexus Medical LLC, Civil
Action 1:07-cv-00057-MPT (D. Del.). According to Appellant, that case has
now been settled (Revised App. Br. filed July 16, 2010 at 2).

2 Both related patents, namely United States Patent 6,447,485 B2
(hereinafter “‘485 Patent” from which the ‘150 Patent claims continuation
status via United States Patent 6,929,625 B2) and United States Patent
6,213,979 B1 (from which the ‘485 Patent claims divisional status), are also
undergoing reexamination in Control Nos. 95/000,271 and 90/010,167
(Appeal No. 2010-007376), respectively.
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The ‘150 Patent states that the “invention relates to anchoring systems
for anchoring medical lines to patients” (col. 1, ll. 17-18). Claims 1 and 31
on appeal read as follows:
1. An anchoring system for securing a medical line to
the body of a patient, the medical line including a fitting, the
system comprising: a retainer including a base that defines a
receiving area for receiving a portion of the fitting of the
medical line, a cover coupled to the base, the cover being
movable between a closed position, in which at least a portion
of the cover extends over at least a portion of the receiving area,
and an open position, in which the receiving area is at least
partially open, a coupling operating between the base and the
cover to releasably connect a portion of the cover to the base
with the cover in the closed position, and interacting structure
which is adapted to engage at least a portion of the fitting and to
inhibit longitudinal movement of the fitting through the retainer
when the fitting is placed within the receiving area, the
interacting structure being located at least partially beneath the
cover with the cover in the closed position.
31. An anchoring system for securing a medical article
to the body of a patient, the medical article having an
irregularly shaped fitting, the anchoring system comprising: an
anchor pad having an upper surface and a lower surface; and a
retainer comprising, a base being coupled to the anchor pad; a
plurality of walls extending generally perpendicular to the base
and being arranged relative to each other so as to secure
between at least portion of the walls the irregularly shaped
fitting of the medical article at least a portion of the secured
irregularly shaped medical article having a lateral width greater
than a distance between said irregularly shaped walls; and a
cover movable coupled to the base so as to move between a first
position and a second position, the cover lying above at least
part of the base when in the first position.
(Claims App’x, App. Br. 24, 27.)

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Patent 7,247,150 B2

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The Examiner relied upon the following as evidence of
unpatentability (Examiner’s Answer mailed February 22, 2010, hereinafter
“Ans.,” 4):
Gordon 4,250,880 Feb. 17, 1981
(Gordon ‘880)
Gordon 4,397,647 Aug. 9, 1983
(Gordon ‘647)
Bierman 5,192,273 Mar. 9, 1993
(Bierman ‘273)
Bierman WO 96/10435 Apr. 11, 1996
(Bierman ‘435)

The Appellant relied on the following rebuttal evidence:
Declaration of Paul Frankhouser executed January 7, 2009 (Ex.
I, App. Br.; hereinafter “Frankhouser Decl.”).

The Examiner rejected claims 1, 31, and 35 under 35 U.S.C. § 102(b)
as follows:
I. Claims 1 and 35 as anticipated by Bierman ‘435 (Ans. 4-
5, 8-9);
II. Claims 1 and 35 as anticipated by Gordon ‘647 (Ans. 5-
6, 10-11);
III. Claim 31 as anticipated by Gordon ‘880 (Ans. 6-7, 12-
13); and
IV. Claim 31 as anticipated by Bierman ‘273 (Ans. 7-8, 14).

In addressing Rejections I and II, Appellant has argued claims 1 and
35 together (App. Br. 6-17). Accordingly, we select claim 1 as
representative of the claims rejected under each of these two grounds and
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confine our discussion to this selected claim. See 37 C.F.R. §
41.37(c)(1)(vii).

REJECTION I: ANTICIPATION BY BIERMAN ‘435
The Examiner found that Bierman ‘435 describes every limitation of
claim 1 (Ans. 5). Specifically, the Examiner found that Bierman ‘435
discloses an anchoring system for anchoring a catheter to the body of a
patient, where the system includes a retainer including a base, a cover
coupled to the base, and an interacting structure in the form of a wing clamp
with holes that cooperate with posts on the retainer to engage and retain a
catheter in place (Ans. 5, 9).
Appellant contends that “engagement and retention of the catheter . . .
in Bierman ‘435 does not mean inhibiting longitudinal motion as recited in
Claim 1” (App. Br. 7). According to Appellant, Bierman ‘435 does not
disclose “sufficient contact” or “sufficient frictional securement” between
the catheter and the wing clamp “to engage at least a portion of the fitting
and to inhibit longitudinal movement,” as recited in claim 1 (App. Br. 8, 9).
In support, Appellant relies on the Frankhouser Declaration (id.; Ex. I).
Thus, the issues are:
(1) Does the phrase “interacting structure which is adapted to
engage at least a portion of the fitting and to inhibit longitudinal movement
of the fitting,” as recited in claim 1, require any particular degree of
frictional contact between the catheter and the interacting structure (i.e.,
wing clamp in certain ‘150 embodiments)?
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(2) Does Bierman ‘435 disclose, either explicitly or inherently, “an
interacting structure which is adapted to engage at least a portion of the
fitting and to inhibit longitudinal movement of the fitting through the
retainer when the fitting is placed within the receiving area,” as recited in
claim 1?
(3) Does the Frankhouser Declaration contain persuasive evidence
demonstrating that the wing clamp described in Bierman ‘435, in concert
with other disclosed elements, would not possess the claimed capability of
inhibiting longitudinal movement of a fitting when a fitting is placed within
the receiving area?

FINDINGS OF FACT (“FF”) RELEVANT TO REJECTION I
1. The ‘150 Patent states that the invention addresses a need “for a
simply-structured anchoring system that affixes a medical line
in a fixed position, but releases the medical line for dressing
changes or other servicing” (col. 1, ll. 53-56).
2. Figures 1A and 1B of the ‘150 Patent are reproduced below:

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Figures 1A and 1B illustrate an anchoring system in accordance
with a preferred embodiment of the invention, wherein the
system 8 includes: a retainer 10 having a base 14; a fitting 11
made up of a catheter box clamp 12 and soft wing clamp 13;
and a cover 22 that may be releasably latched onto the base 14
by cooperation with posts 20 provided with enlarged heads 26
and annular rings 28 (col. 4, l. 26 to col. 12, l. 51).
3. The ‘150 Patent informs one skilled in the relevant art that an
“interacting structure [located generally beneath the cover] is
adapted to limit movement of the medical line through [sic,
relative] to the retainer when the catheter is placed within the
receiving area” (col. 2, ll. 2-5).
4. The ‘150 Patent further describes the term “interacting
structure” as follows (col. 5, ll. 21-29):
The base 14 and the catheter 15 desirably include
interacting structure to couple the catheter 15 to
the base 14. As will be clear from the disclosure
below, the interacting structure mounts the medical
line either directly or by way of a fitting (e.g., the
box clamp 12 and soft wing clamp 13) to the base
14. In the latter case, a portion of the interacting
structure desirable is formed on the fitting and
another portion of the interacting structure is
formed on the retainer.
The post 20 is also described as part of the interacting
structure of base 14 (col. 5, ll. 40-43).
5. According to the ‘150 Patent, the term “mount” describes a
“condition in which the interacting structure inhibits movement
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of the catheter 15 relative to the retainer 10 in at least one
degree of freedom (e.g., rotational, lateral, longitudinal or
transverse)” (emphasis added; col. 5, ll. 30-40).
6. The ‘150 Patent also informs one skilled in the relevant art as
follows (col. 5, l. 55 to col. 6, l. 1):
For anchoring catheters and medical tubing, each
post 20 desirably has a length of about 4 mm to 20
mm, and more particularly a length of about 6 mm;
however, longer or shorter lengths also are
possible. The posts 20 are laterally spaced at least
wide enough to accommodate the medical line to
be anchored, and in the illustrated embodiments,
the posts 20 are spaced to accommodate the fitting
11 which secures the medical line . . . The shaft 25
of each post 20 has a diameter sufficient to
perform its structural function, as described in
more detail below, and depends on the material
chosen for the base 14 and shafts 25.
7. The ‘150 Patent states that when a fitting 11 is used, the
relatively rigid box clamp body 60 of box clamp 12 “exerts
relatively more inward pressure on the catheter than the
relatively more flexible wing clamp 13, such that a better
frictional grip holds the catheter within the fitting 11”
(emphasis added; col. 10, ll. 37-41).
8. Furthermore, the ‘150 Patent discloses that the “cover material
at the waist 37 and/or the shaft 25 slightly compresses as the
cover 22 is shifted under force provided by the health care
provider” and that “the resulting engagement . . . serves to
retain the fitting 11 securely in place within the retainer 10”
(col. 11, ll. 12-19).
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9. The ‘150 Patent discloses that “wing clamp 13 [of Figure 1A] is
constructed from a soft, pliable or flexible material such as, for
example, latex or the like” and that its “central elongate body
70 includes a longitudinal slit 75 along its underside,” thus
allowing the wing clamp 13 to be “placed on and surrounding
and longitudinally contacting in a frictional manner a portion of
the catheter” (col. 8, l. 66 to col. 9, l. 6).
10. Figure 11 of the ‘150 Patent is reproduced below:

Figure 11 of the ‘150 Patent depicts an alternative embodiment
in which the fitting/medical line can be moved in the lateral
direction during engagement or disengagement of cover 22c.
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11. The ‘150 Patent also discloses that “the skilled artisan will
recognize the interchangeability of various features from
different embodiments” (col. 20, ll. 27-29).
12. The inventor identified in the Bierman ‘435 reference appears
to be the same individual named as inventor in the current ‘150
Patent under reexamination.
13. Figure 9 of Bierman ‘435 is reproduced below:

Figure 9 of Bierman ‘435 shows an anchoring system 10 for
releasably retaining a catheter, the system including a retainer
20 provided with posts 17, a wing clamp 18 constructed from a
soft, pliable, or flexible material such as latex, and a box clamp
14 constructed of a substantially rigid plastic material such as a
polymeric material and provided with holes 42 that cooperate
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with posts 17 having enlarged heads (p. 4, ll. 10-28; p. 5, ll. 5-6,
15-21; p. 7, ll. 30-32).
14. According to Bierman ‘435, “the wing clamp 18 is capable of
surrounding and engaging longitudinally a portion of the
catheter 12 to provide a secure means for engaging and
retaining the catheter 12 in place” (p. 5, ll. 20-21).
15. The Frankhouser Declaration states (Ex. I, ¶¶ 9, 12, 13, 29):
9. A peripherally inserted central catheter
(“PICC”) and central venous catheter (“CVC”) are
more sensitive to bacteria because they are
typically inserted further into the vein than a
normal IV catheter. In addition, small movements
of a PICC/CVC and/or the medical line can cause
movement in and out of the insertion site in the
body that is sometimes called “pistoning.” This
also increases the risk of infection. For these
reasons, healthcare professionals have often
sutured a PICC or CVC to a patient. But suturing
creates an opportunity for the healthcare
professional to suffer a needle stick. In addition,
suturing is painful for the patient and could itself
cause infection. Because of these problems, there
was a need to securely affix PICC and CVC
catheters in a way that would eliminate the need
for suturing but still limit pistoning.
12. For two independent reasons, a person
of ordinary skill in the art of medical devices
would understand that this [Bierman ‘435] device
could not limit longitudinal movement of the
medical line 12. First, medical line 12 is not fixed
relative to the wing clamp 18. Although the
system would prevent the wing clamp and box
clamp from moving longitudinally once the posts
are secured within the retainer, the medical line
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could be pulled through the wing clamp because
the medical line is not fixed to the wing clamp.
Also, the combination of the wing clamp and box
clamp could more significantly frustrate
longitudinal movement than the wing clamp alone.
But the combination could only do this by
squeezing the medical line tightly enough to limit
longitudinal movement. The Bierman PCT,
however, never discloses how tightly the medical
line must be squeezed in order to do so. Moreover,
one of skill in the art would understand that by
squeezing the medical line tightly enough to limit
longitudinal movement, the medical line would be
significantly occluded, which would be
undesirable.
13. Second, even if the medical line could
not move relative to the wing clamp, the
combination of the wing clamp and box clamp
must be moved laterally when the posts from the
box clamp are placed in the holes in the retainer.
One of skill in the art would understand that
securement devices such as the one disclosed in
the Bierman PCT are put into place after the
needle at the end of the medical line has already
been inserted into the patient. Also, a healthcare
professional may also wish to disengage or
reengage the combination of the wing clamp and
box clamp from the retainer without removing the
needle from the patient. Thus, one of skill in the
art would understand that the lateral movement at
the retainer would be translated into both lateral
and longitudinal movement at the injection site.
29. I am familiar with Venetec’s Statlock
PICC Plus Device. Venetec’s Statlock PICC Plus
Device has interacting structure that inhibits a
medical line from slipping out of the retainer. The
device does this by interfering with a surface of the
fitting, adaptor or medical line.
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PRINCIPLE OF LAW FOR REJECTION I
“During reexamination, as with original examination, the PTO must
give claims their broadest reasonable construction consistent with the
specification . . . . Therefore, we look to the specification to see if it provides
a definition for claim terms, but otherwise apply a broad interpretation.” In
re ICON Health and Fitness, Inc., 496 F.3d 1374, 1379 (Fed. Cir. 2007).

ANALYSIS FOR REJECTION I
We start with claim construction. Appellant has not directed us to any
description in the ‘150 Patent that quantifies a particular degree of
engagement and/or inhibition in the longitudinal movement of the catheter.
While the degree of engagement or inhibition must necessarily be sufficient
to result in a workable anchoring system, the disclosure of the ‘150 Patent
places no specific limitation – e.g., by way of specific dimensions of the
elements and/or specific materials of manufacture – on the amount of
frictional force required by the claim language “to engage at least a portion
of the fitting and to inhibit longitudinal movement” (FF 1, 3-9). We
therefore construe the disputed limitation as reading on any degree of
engagement or inhibition, however slight, as long as the anchoring system is
operable during use.
The Examiner’s findings that Bierman ‘435 describes a “retainer,” a
“cover,” and a “coupling,” all as arranged and recited in claim 1 are
undisputed (Ans. 5; App. Br. 6-10). Instead, Appellant contends that
“Bierman ‘435 does not disclose structure that is adapted to engage with and
to inhibit longitudinal movement of the fitting” (App. Br. 6).
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We cannot agree with Appellant. The posts 17 with enlarged heads
and wing clamp 18 with holes that interact with posts 17 as in Figure 9 of
Bierman ‘435 are either the same or substantially the same as the structures
disclosed in the ‘150 Patent as corresponding to the disputed “interacting
structure which is adapted to engage at least a portion of the fitting” and are
arranged or assembled in substantially the same manner as disclosed in the
‘150 Patent (FF 2-4, 7-9, 13). More importantly, Bierman ‘435 plainly
teaches that wing clamp 18 provides a “secure means for engaging and
retaining the catheter in place” (italics added; FF 14). These facts support
the Examiner’s rejection because the structures described in Bierman ‘435
would reasonably appear to “engage at least a portion of the fitting and to
inhibit longitudinal movement” to the same or similar extent as the invention
recited in claim 1.
We find no basis in the written description to limit the claim language
to an “interference fit,” as urged by Appellant (App. Br. 9). As we discussed
at the outset, the ‘150 Patent places no limitation as to the degree of
engagement, inhibition, or friction required, as long as the anchoring system
is operable during use. Bierman ‘435 describes exactly that.
The Frankhouser Declaration fails to demonstrate otherwise (FF 15).
While the Declaration asserts that Bierman’s “medical line 12 is not fixed
relative to the wing clamp 18,” the disclosure in Bierman ‘435 contradicts
that testimony. Bierman ‘435 teaches a medical line with fitting that is fixed
to the same or similar extent that catheter 15 is fixed to the soft wing clamp
13 in the ‘150 Patent (FF 2-5, 7-9, 13, 14). We also do not credit Mr.
Frankhouser’s unsupported conclusion that “the medical line could be pulled
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through the wing clamp” because it is contrary to the plain teaching in
Bierman ‘435 that wing clamp 18 provides “a secure means for engaging
and retaining the catheter 12 in place” (FF 14). To the extent that Bierman
‘435 does not disclose how tightly the catheter should be squeezed, the lack
of such clarity is equally applicable to the disclosure of the ‘150 Patent. But
more importantly, Mr. Frankhouser fails to explain why a person of ordinary
skill in the art would not have been able to size and assemble the elements
such that the catheter is squeezed sufficiently to engage and retain the
catheter “in place,” as explicitly taught in Bierman ‘435. Finally, to the
extent that “lateral movement at the retainer [of the Bierman ‘435 device]
would be translated into both lateral and longitudinal movement at the
injection site,” as alleged in the Frankhouser Declaration, the same
disadvantage would appear to be present in the invention of the ‘150 Patent
because the structures disclosed in the ‘150 Patent and Bierman ‘435 are
substantially the same and thus would reasonably appear to possess the same
or similar functional characteristics (FF 6, 10, 11). Indeed, the disclosure of
the ‘150 Patent as a whole appears to indicate that the invention
encompasses structures that allow for lateral movement (Fig. 11; FF 10, 11).
For these reasons, we uphold Rejection I.

REJECTION II: ANTICIPATION BY GORDON ‘647
The Examiner found that Gordon ‘647 describes every limitation of
claim 1, including the recited “interacting structure which is adapted to
engage at least a portion of the fitting and to inhibit longitudinal movement
of the fitting” (Ans. 5-6, 10-11). According to the Examiner, a “fitting” is
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not positively recited as part of the claimed “anchoring system” and
therefore Gordon anticipates (Ans. 10). In what appears to be an alternative
theory, the Examiner alleges that “the gripping portion 55 is an interacting
structure that engages with at least a portion of the fitting 50” (i.e., the
Examiner believes that the catheter tube 50 is also a “fitting”) (Ans. 6).
Appellant contends that the gripping projection 55 described in
Gordon ‘647 is not an “interacting structure” because it “is configured to
secure a medical tube 50, not a fitting as recited numerous times in Claim 1”
(App. Br. 12).
Thus, the dispositive issues are:
(4) Does claim 1 require at least a portion of the fitting as part of
the claimed “anchoring system”?
(5) Did the Examiner demonstrate that catheter 50 of Gordon ‘647
is a “fitting” as recited in claim 1?

FACTS RELEVANT TO REJECTION II
16. Figures 6-9 of Gordon ‘647 are reproduced below:
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Figures 6-9 of Gordon ‘647 depict a stabilizing device 40 for a
catheter including, inter alia, a base member 41, a base portion
43, a pair of upstanding arcuate side walls 44 and 45 defining
recesses 47 and 48 for accepting the catheter tube 50, a latch
member 53 projecting radially from side wall 44, and a snap-
over cover 46 provided with a gripping projection 55 (col. 6, l.
15 to col. 7, l. 49).
17. Regarding the gripping projection 55, Gordon ‘647 teaches
(col. 7, ll. 33-42):
The underside of strap 46 is provided with a
gripping projection 55 which is positioned
lengthwise along strap 46 so as to project
downwardly between side walls 44 and 45 when
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the strap is latched closed. The gripping projection
extends sufficiently far down into the space
between the side walls 44 and 45 to engage and
slightly crimp the catheter tube 50 (as best
illustrated in FIG. 9), forcing the catheter tube
slightly downward into the central opening 49 at
the center of the annular base portion 43.

PRINCIPLE OF LAW FOR REJECTION II
“[I]t would be unreasonable for the PTO to ignore any interpretive
guidance afforded by the applicant’s written description.” In re Morris, 127
F.3d 1048, 1054 (Fed. Cir. 1997).

ANALYSIS FOR REJECTION II
We agree with Appellant that Gordon ‘647 does not anticipate. Claim
1 explicitly and positively recites an “interacting structure which is adapted
to engage at least a portion of the fitting” as a component of the claimed
“anchoring system.” According to the ‘150 Patent, “a portion of the
interacting structure desirable is formed on the fitting and another portion of
the interacting structure is formed on the retainer” (FF 4). We therefore
construe the term “interacting structure which is adapted to engage at least a
portion of the fitting” to be partly formed on the fitting. Contrary to the
Examiner’s belief, the catheter tube 50 of Gordon ‘647 has not been shown
to be or include a “fitting,” as recited in claim 1 (FF 16, 17).
Hence, we cannot uphold this rejection.

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REJECTION III: ANTICIPATION BY GORDON ‘880
The Examiner found that Gordon ‘880 describes every limitation of
claim 31, including “a plurality of walls 26, 32, 60, 62 extending from the
base that are arranged to secure between an irregularly shaped fitting 38”
(Ans. 6-7).
Appellant contends that the fitting described in Gordon ‘880 is not
“irregularly shaped” because “an irregular shape is non-uniform in its
circumference” (App. Br. 18). In support, Appellant relies on the
Frankhouser Declaration (¶¶ 27, 28). Furthermore, Appellant argues that the
fitting in Gordon ‘880 is not secured (App. Br. 18-19).
Thus, the issues are:
(6) Does Gordon ‘880 describe a plurality of walls that are
configured to secure an “irregularly shaped fitting,” as recited in claim 31?
(7) If so, does Gordon ‘880 disclose that the fitting is secured in the
same or similar manner as that disclosed in the ‘150 Patent?

FACTS RELEVANT TO REJECTION III
18. The ‘150 Patent does not contain a definition of the term
“irregularly shaped.”
19. Figures 10A and 10B of the ‘150 Patent are reproduced below:
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Figures 10A and 10B of the ‘150 Patent depict another
embodiment in which an adaptor 11c, which is connected to
medical tubes, can be mounted within a channel defined within
mounting structure 140 (col. 19, ll. 3-4, 21-22; col. 20, ll. 6-9).
20. Figures 16 and 17 of Gordon ‘880 are reproduced below:

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Figures 16 and 17 of Gordon ‘880 depict a fitting for securely
stabilizing an intravenous catheter to a patient, wherein the
fitting is securely placed in a cradle by means of cooperation
with ribs 60 and wall 62 (col. 1, ll. 36-39; col. 3, ll. 60-63; col.
4, l. 52 to col. 5, l. 9; col. 4, ll. 21-51).
21. The Frankhouser Declaration states that “[r]ounded or other
regular geometric shapes, such as spheres, cylinders, squares,
and rectangles, are not irregularly shaped” and that the fitting
described in Gordon ‘880 “is symmetrical along its longitudinal
axis” (Ex. I, ¶¶ 27, 28).

PRINCIPLE OF LAW RELEVANT TO REJECTION III
“[T]he PTO must give claims their broadest reasonable construction
consistent with the specification.” In re ICON Health, 496 F.3d at 1379.

ANALYSIS FOR REJECTION III
We agree with the Examiner’s conclusion that when the term
“irregularly shaped” is construed as broadly as the terms reasonably allow in
light of the ‘150 Patent Specification, it encompasses the fitting described in
Gordon ‘880, which has an irregular shape along its longitudinal axis by
reason of varying cross-sectional diameters (FF 20). Nothing in the ‘150
Patent reasonably apprises one skilled in the relevant art that the term
“irregularly shaped,” which does not even appear literally in the written
description, must be construed to read on the shape depicted in Figures 10A
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and 10B of the ‘150 Patent but not the shape depicted in Figures 16 and 17
of Gordon ‘880 (FF 18 and 19).
We do not credit Mr. Frankhouser’s testimony because it is devoid of
any discussion as to how the conclusions made therein are factually
supported by the written description of the ‘150 Patent (FF 21). Even if we
credited Mr. Frankhouser’s testimony, it would exclude the embodiment
shown in Figures 10A and 10B of the ‘150 Patent because the shape, like
that shown in Gordon ‘880, is also symmetrical along its longitudinal axis.
Appellant also urges that Gordon ‘880 does not teach securing the
fitting (App. Br. 18-19). We find no persuasive merit in this argument
because Gordon ‘880 teaches that the catheter is securely stabilized (FF 20).
For these reasons, we uphold the Examiner’s rejection of claim 31.

REJECTION IV: ANTICIPATION BY BIERMAN ‘273
The Examiner found that Bierman ‘273 describes every limitation of
claim 31, including “a cover 36 movable [sic] coupled to the base that
moves between a first position and a second position” (Ans. 8).
Appellant contends that Bierman ‘273 describes no such cover as
recited in the claim (App. Br. 22-23).
Thus, the issue is:
(8) Does Bierman ‘273 “a cover movabl[y]coupled to the base so
as to move between a first position and a second position,” as recited in
claim 31?

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FACTS RELEVANT TO REJECTION III
22. Every embodiment depicted in the ‘150 Patent shows a cover
that is coupled to the base (e.g., by means of coupling 24 in
Figure 1A).
23. Figures 2 and 3 of Bierman ‘273 are reproduced below:

Figures 2 and 3 of Bierman ‘273 depict a catheterization
apparatus, wherein the apparatus includes a clip 36 attached to a
catheter hub 40 and ratchet element 50 (col. 5, l. 18 to col. 6, l.
25).
Appeal 2010-007390
Reexamination Control 90/010,211
Patent 7,247,150 B2

24

PRINCIPLE OF LAW RELEVANT TO REJECTION IV
A necessary requirement of the broadest reasonable construction rule
is that the construction must be reasonable in light of the specification. In re
Suitco Surface, Inc., 603 F.3d 1255, 1260 (Fed. Cir. 2010).

ANALYSIS FOR REJECTION IV
In response to Appellant’s argument that the cover in Bierman ‘273 is
not coupled to the base, the Examiner asserts that “[i]t is immaterial whether
the clip 36 mounts to the ratchet element 50 or the base 32 – when the
device is fully assembled, it meets the claimed limitation of the cover (clip
36) being movably coupled to the base, since the ratchet element 50 is
mounted or attached to the clip 36” (Ans. 14). This assertion fails to address
the argument that the cover is not “movable coupled” to the base, as required
by claim 31.
Accordingly, we cannot uphold this rejection.

CONCLUSION
On this record, we find that:
(1) The phrase “interacting structure which is adapted to engage at
least a portion of the fitting and to inhibit longitudinal movement of the
fitting,” as recited in claim 1, does not require any particular degree of
frictional contact between the catheter and the interacting structure (i.e.,
wing clamp in certain ‘150 embodiments).
Appeal 2010-007390
Reexamination Control 90/010,211
Patent 7,247,150 B2

25
(2) Bierman ‘435 discloses, either explicitly or inherently, “an
interacting structure which is adapted to engage at least a portion of the
fitting and to inhibit longitudinal movement of the fitting through the
retainer when the fitting is placed within the receiving area,” as recited in
claim 1.
(3) The Frankhouser Declaration does not contain persuasive
evidence demonstrating that the wing clamp described in Bierman ‘435, in
concert with other disclosed elements, would not possess the claimed
capability of inhibiting longitudinal movement of a fitting when a fitting is
placed within the receiving area.
(4) Claim 1 requires at least a portion of the fitting as part of the
claimed “anchoring system.”
(5) The Examiner failed to demonstrate that catheter 50 of Gordon
‘647 is a “fitting” as recited in claim 1.
(6) Gordon ‘880 describes a plurality of walls that are configured
to secure an “irregularly shaped fitting,” as recited in claim 31.
(7) Gordon ‘880 discloses that the fitting is secured in the same or
similar manner as that disclosed in the ‘150 Patent.
(8) Bierman ‘273 has not been shown to disclose “a cover
movabl[y]coupled to the base so as to move between a first position and a
second position,” as recited in claim 31.

DECISION
The Examiner’s decision to reject claims 1, 31, and 35 is affirmed.
Appeal 2010-007390
Reexamination Control 90/010,211
Patent 7,247,150 B2

26
Requests for extensions of time in this ex parte reexamination
proceeding are governed by 37 C.F.R. § 1.550(c). See 37 C.F.R. § 41.50(f).
AFFIRMED

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