Ex Parte 6699221 et al

Board of Patent Appeals and Interferences

Jun 29, 2012

95000565 (B.P.A.I. Jun. 29, 2012)

UNITED STATES PATENT AND TRADEMARKOFFICE
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.
95/000,565 08/12/2010 6699221 0006675.00277US1 2323
7590 06/29/2012
Francis C. Hand, Esq.
c/o CARELLA, BYRNE, BAIN, GILFILLAN et al.
6 Becker Farm Road
Roseland, NJ 07068
EXAMINER
CLARK, JEANNE MARIE
ART UNIT PAPER NUMBER
3993
MAIL DATE DELIVERY MODE
06/29/2012 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

BECTON, DICKINSON AND COMPANY
Requester & Respondent

v.

MICHAEL J. VAILLANCOURT
Patent Owner & Appellant
____________

Appeal 2012-003151
Application 95/000,565
Patent 6,699,221 B2
Technology Center 3900
____________

Before RICHARD M. LEBOVITZ, JEFFREY B. ROBERTSON, and
RAE LYNN P. GUEST, Administrative Patent Judges.

GUEST, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal by the Patent Owner from the Patent Examiner’s
rejections of claims 1-37 in an inter partes reexamination of U.S. Patent 6,699,221
B2, issued March 2, 2004. The Board’s jurisdiction for this appeal is under 35
U.S.C. §§ 6, 134, and 315. We AFFIRM.
Appeal
Applica
Patent 6

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Appeal 2012-003151
Application 95/000,565
Patent 6,699,221 B2

3

construction of hub 11, cannula 12, introducer needle 14, and needle hub 13 as
“conventional.” (The ‘221 patent, col. 2, ll. 31-33 and col. 3, ll. 3-12.)
The catheter of the ‘221 patent also includes a seal 16 and tube 15
arrangement, as depicted in Figure 1 above (‘221 patent, col. 1, ll. 46-49, col. 2, ll.
34-36, col. 3, ll. 13-18).

REJECTIONS
The Examiner rejected the claims as follows:3
1. Claims 1-3, 6, 23, and 25 under 35 U.S.C § 102(b) as anticipated by Cox4
(see Rejections 1 and 31).
2. Claims 1-3, 6, 22, 23, and 25 under 35 U.S.C. § 103(a) as obvious over Cox
(see Rejections 2 and 30).
3. Claims 1-3, 6, 16, 24 and 26 under 35 U.S.C. § 103(a) as obvious over Cox
in view of Sylvanowicz5 (see Rejections 3 and 32).
4. Claim 17 under 35 U.S.C. § 103(a) as obvious over Cox in view of Fischell.6
5. Claims 1, 3, 6, 10-14, and 18 under 35 U.S.C § 102(b) as anticipated by
Luther.7

3 See Action Closing Prosecution, dated January 24, 2011, (hereinafter “ACP”) at
2-25 and Right of Appeal Notice, dated April 5, 2011, (hereinafter “RAN”) at 3
and 6-29.

4 Cox et al., US 4,935,010, issued June 19, 1990 (hereinafter “Cox”).

5 Sylvanowicz, et al., US 5,304,156, issued April 19, 1994 (hereinafter
“Sylvanowicz”).

6 Fischell et al., US 5,295,969, issued March 22, 1994 (hereinafter “Fischell”).

Appeal 2012-003151
Application 95/000,565
Patent 6,699,221 B2

4

6. Claims 1, 3, 6, 10-14, and 18 under 35 U.S.C. § 103(a) as obvious over
Luther.
7. Claims 1, 3, 6, 10-14, and 18 under 35 U.S.C. § 103(a) as obvious over
Luther in view of Cox.
8. Claims 1, 3, 6, 10-14, 16, and 18 under 35 U.S.C. § 103(a) as obvious over
Luther in view of Sylvanowicz.
9. Claim 17 under 35 U.S.C. § 103(a) as obvious over Luther in view of
Fischell.
12. Claims 1-3, 6, 13-16 under 35 U.S.C. § 103(a) as obvious over Van
Heugten8 in view of Sylvanowicz.
13. Claim 17 under 35 U.S.C. § 103(a) as obvious over Van Heugten in view of
Sylvanowicz and Fischell.
14. Claims 1-3, 6, 10-15, and 20 under 35 U.S.C. § 103(a) as obvious over Van
Heugten in view of Luther (see Rejection 14).
15. Claims 1-4, 6, 7, 9, 15, 19, 27, 29, and 30 under 35 U.S.C § 102(b) as
anticipated by Vaillancourt ‘7669 (see Rejections 15 and 33).

7 Luther, US 4,842,591, issued June 27, 1989 (hereinafter “Luther”).

8 Van Heugten, US 5,053,014, issued October 1, 1991 (hereinafter “Van
Heugten”).

9 Vailancourt, US 4,512,766, issued April 23, 1985. It is believed that the ‘766
patent misspelled the inventor’s name and that the inventor is, in fact, the same
Vincent L. Vaillancourt of Livingston, NJ, named in the ‘221 patent and other
references cited herein. Thus, hereinafter the ‘766 patent will be referred to as
“Vaillancourt ‘766”.

Appeal 2012-003151
Application 95/000,565
Patent 6,699,221 B2

5

16. Claims 1-4, 6-9, 15, 19, and 27-30 under 35 U.S.C. § 103(a) as obvious
over Vaillancourt ‘766 (see Rejections 16 and 34).
17. Claims 1-9, 15, and 19 under 35 U.S.C. § 103(a) as obvious over
Vaillancourt ‘766 in view of Vaillancourt ‘891.10
20. Claim 22 under 35 U.S.C. § 103(a) as obvious over Cox in view of
Vaillancourt ‘728.
21. Claim 21 under 35 U.S.C. § 103(a) as obvious over the other rejections of
claim 1 further in view of Vaillancourt ‘72811 (see Rejections 21-28).
33. Claim 27, 29, and 30 under 35 U.S.C § 102(b) as anticipated by or,
alternatively, under 35 U.S.C. § 103(a) as obvious over Vaillancourt ‘766
(see Rejections 33 and 34).
26. Claim 33 under 35 U.S.C. § 103(a) as obvious over Van Heugten in view of
Luther and Vaillancourt ‘728.
27. Claim 28 under 35 U.S.C. § 103(a) as obvious over Vaillancourt ‘766,
either alone or further in view of Vaillancourt ‘728 or Vaillancourt ‘891 and
Vaillancourt ‘728 (see Rejections 27, 28, and 34).
36. Claim 31 under 35 U.S.C. § 103(a) as obvious over Vaillancourt ‘766 in
view of Cox.
38. Claim 32 under 35 U.S.C. § 103(a) as obvious over Vaillancourt ‘766 in
view of Cox and Sylvanowicz.

10 Vaillancourt, US 5,669,891, issued September 23, 1997 (hereinafter
“Vaillancourt ‘891”).

11 Vaillancourt, US 5,487,728, issued January 30, 1996 (hereinafter “Vaillancourt
‘728”).
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Patent 6,699,221 B2

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40. Claims 34 and 36 under 35 U.S.C. § 103(a) as obvious over Van Heugten in
view of Luther and Cox.
41. Claim 35 under 35 U.S.C. § 103(a) as obvious over Van Heugten in view of
Luther and Sylvanowicz.
42. Claim 37 under 35 U.S.C. § 103(a) as obvious over Van Heugten in view of
Luther, Cox, and Sylvanowicz (see Rejection 42).
Claims 1, 19 and 20 are independent claims. Patent Owner presents arguments
with respect to each rejection separately. We have considered each of Patent
Owner’s arguments separately. We discuss in detail below Rejections 1-6, 14, 16,
17, 26, 30-32, 34, 36, 38, and 40-42, as enumerated by the Examiner. Based on
our decisions regarding these rejections, we find it unnecessary to address the
merits of the remaining Examiner’s rejections, namely Rejections 7-13, 15, 20-25,
27, 28 and 33, as enumerated by the Examiner. Moreover, we consolidate similar
issues in our analysis below, where appropriate.
REPRESENTATIVE CLAIM
Claim 1 is representative and reads as follows (App. Br., Claim App’x 1):
1. A bloodless catheter comprising
a first hub having a bore at a proximal end;
a cannula fixed in and extending from an opposite distal end of
said hub for invasive positioning in a blood vessel; and
a septum seal mounted in said bore of said hub in
circumferentially sealed relation to prevent a flow of fluid from said
cannula to said proximal end of said hub, said seal having a weakened
central section.
CLAIM INTERPRETATION
The meaning of the limitation “mounted in said bore of said hub in
circumferentially sealed relation” is in dispute in this appeal. During
reexamination, “claims . . . are to be given their broadest reasonable interpretation
Appeal 2012-003151
Application 95/000,565
Patent 6,699,221 B2

7

consistent with the specification, and . . . claim language should be read in light of
the specification as it would be interpreted by one of ordinary skill in the art.” In
re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004) (quoting In
re Bond, 910 F.2d 831, 833 (Fed. Cir. 1990)).
We begin by interpreting the term “mounted” as it appears in the phrase “a
septum seal mounted in said bore of said hub.” Patent Owner directs us to features
described as “mounted” in the ‘221 patent that are designed to be movable (App.
Br. 10-11). However, the term “mounted” is used in the ‘221 patent alone and
with the qualifiers “slidably” and “telescopically” (see e.g., ‘221 patent, col. 2, ll.
1-3, col. 2, ll. 19-22, and col. 3, ll. 12-15). Therefore, the term “mounted” is not
expressly defined in the ‘221 patent. “Absent an express definition in their
specification, the fact that appellants can point to definitions or usages that
conform to their interpretation does not make the PTO’s definition unreasonable
when the PTO can point to other sources that support its interpretation.” In re
Morris, 127 F.3d 1048, 1056 (Fed. Cir. 1997); see also In re Bigio, 381 F.3d 1320,
1324-25 (Fed. Cir. 2004) (Absent claim language carrying a narrow meaning, we
only limit the claim based on the specification when those sources expressly
disclaim the broader definition.); In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir.
1994) (An inventor may choose to be his own lexicographer if he defines the
specific terms used to describe the invention “with reasonable clarity,
deliberateness, and precision.”).
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The ordinary meaning of the word “mounted” is placed or fixed on or in an
appropriate support, or, more generally, “supported.”12 Thus, in addition to
embodiments where the septum seal is movable, as described in certain preferred
embodiments in the ‘221 patent, the term “mounted,” recited in the claim also
clearly encompasses septum seals that are supported in any manner, including a
permanent or fixed manner.
The claim also has “a first hub having a bore at a proximal end.” Patent
Owner contends that the “bore” of the “hub” is precluded from having a recess,
which is absent in the figures of the ‘221 patent (App. Br. 10-11). However, the
term “bore” is not defined in the ‘221 patent, and we decline to limit the meaning
to the particular examples in the ‘221 patent. Phillips v. AWH Corp., 415 F.3d
1303, 1323 (Fed. Cir. 2005) (“[A]lthough the specification often describes very
specific embodiments of the invention, we have repeatedly warned against
confining the claims to those embodiments.”). The term “bore” generally means a
hollow chamber or barrel or the inner surface thereof that is “usually” cylindrical.13
Thus, a “bore” need not necessarily be cylindrical and recesses formed within a

12 See e.g., http://www.thefreedictionary.com/mount, sense 6a and 6b, accessed
May 31, 2012 (sense 6a “to fix securely to a support” and sense 6b “to place or fix
on or in the appropriate support or setting for display or study”);
http://www.merriam-webster.com/dictionary/mount, sense 6a, accessed May 31,
2012 (“to attach to a support”).

13 See e.g., http://www.thefreedictionary.com/bore, sense 2 and 3, accessed May
31, 2012 (“a hollow, usually cylindrical chamber or barrel, as of a firearm” and
“the interior diameter of a hole, tube, or cylinder”); http://www.merriam-
webster.com/medical/bore, sense 1 and 2, accessed May 31, 2012 (“the long
usually cylindrical hollow part of something (as a tube or artery)” and “the internal
diameter of a tube (as a hypodermic needle, catheter or sound)”).
Appeal 2012-003151
Application 95/000,565
Patent 6,699,221 B2

9

hollow chamber or barrel are not precluded from constituting a portion of the
“bore.”
The phrase “circumferentially sealed relation,” defining the relationship
between the seal and bore, is also not defined in the ‘221 patent. On its face, the
phrase means that the septum seal and the bore are related such that a seal is
formed around a circumference of the seal. The ‘221 patent describes an
“interference fit” as an example of a “circumferentially sealed relation” (‘221
patent, col. 3, ll. 41-46), but the ‘221 patent does not expressly limit the type of
seal to an interference fit. The broad claim language does not limit the type of seal
or how the seal is formed, and we decline to read any limitations into the claim
from the specification when there is no express teaching to do so. See Phillips, 415
F.3d at 1323.
1. ANTICIPATION BASED ON COX (Rejections 1 and 31)
The Examiner rejects claims 1-3, 6, 23, and 25 as anticipated by Cox. Patent
Owner presents arguments with respect to claims 1-3 and 6 as a group and presents
no separate argument with respect to claim 25 over that of claim 1 (App. Br. 6-9
and 44). Patent Owner presents separate arguments with respect to claim 23 (App.
Br. 43-44). Accordingly, we select claims 1 and 23 as representative claims.
Claims 1-3, 6, and 25
The Examiner rejects claim 1 as anticipated by Cox. Figure 7 of Cox is
reproduced below.
Appeal
Applica
Patent 6

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intraven
(not lab
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the claim
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The issu
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2012-0031
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cannula d
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Cox depic
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ate a claim
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Cir. 1997)
recited in
s is: Unde
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“hub” (i.e
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col. 5, ll. 3
are not pe
oes not rea
as the Exa
” (App. Br
ts a sectio
nnula 61 t
x, col. 2, l
, a prior ar
explicitly
. Patent O
claim 1 ar
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e Examine
an opposit
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at cannula
., housing
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7-39 and
rsuaded b
d on the “
miner clea
. 7-8; ACP
10
nal elevati
hat is inte
l. 50-51 an
t referenc
or inheren
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e disclose
interpreta
r finding t
e distal en
e answer t
61 of Co
2) (ACP 2
ousing 2
Fig. 7).
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trocar 66”
rly does n
2).

on view of
grally form
d col. 5, l
e must dis
tly.” In r
ests the Ex
d in Cox (
tion of the
hat Cox d
d of said h
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). In addi
and comm
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and “conn
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ed with a
l. 34-45).
close every
e Schreibe
aminer’s f
App. Br. 6
language
iscloses “a
ub” and “
n in the a
r is “fixed
tion, Cox’
unicating
guments th
ection me
these elem
for use in
housing 2
limitatio
r, 128 F.3
inding tha
-9 and 44)
of claim 1
cannula
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ffirmative.
in and
s catheter
with the fi
at the
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.
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has
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e
Appeal 2012-003151
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Patent 6,699,221 B2

11

Patent Owner further argues that the Specification of the ‘221 patent requires
that the hub and cannula be “two separate parts,” citing portions of the
Specification referring to the cannula as “fixed in and extending from” the hub and
stating generally that the Figures show “the cannula 12 being made separate from
and of a different material from hub 11” (App. Br. 8) (citing col. 1, ll. 50-53 and
col. 3, ll. 3-9).
To the extent that Patent Owner is arguing that the claimed invention does
not read on Cox’s catheter because cannula 61 is not a separate part from housing 2
(which is not labeled in Figure 7 above), we see no reason to conclude that the
phrase “fixed in and extending from” would necessarily require that the cannula
and the hub be “separate” as suggested by the Patent Owner. The term “fixed”
commonly means “securely placed or fastened.”14 We are not persuaded that the
Specification expressly requires that the term “fixed” precludes an integral
structure merely because the Figures of the ‘221 patent illustrate a separable
structure. We decline to strictly limit the scope of the claims to the embodiments
in the figures of the ‘221 patent. See Phillips, 415 F.3d at 1323.
The Examiner finds that membrane 4 is a septum seal “mounted in said bore
of said hub in circumferentially sealed relation” (ACP 2-3). Patent Owner
contends that membrane 4 is not “mounted in said bore of said hub” because it is
“held in a shoulder recess of one housing part by a second housing part” and “is
not capable of being moved as the membrane is fixed in place” (App. Br. 9).
Based on the claim interpretation discussed above, the phrase “mounted in said
bore of said hub” does not preclude the septum seal from being permanently fixed

14 http://www.merriam-webster.com/dictionary/fixed, sense 1a, accessed June 14,
2012.
Appeal 2012-003151
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Patent 6,699,221 B2

12

or disposed in a recess that defines a portion of a bore. To the extent that Patent
Owner is arguing that a bore cannot be defined by more than one housing part,
Patent Owners have provided no persuasive evidence that the term “bore” should
be so limited.
Accordingly, considering the broadest reasonable interpretation of the terms
recited in claim 1, we agree with the Examiner’s finding that that claim 1 reads on
the device structure described in Cox.

Claim 23
Claim 23 depends from claim 1 and further requires that the “seal is sealed
in an interference fit manner to said bore of said hub, said interference fit
determining the maximum pressure allowable in said catheter before leakage into
said proximal end of said hub occurs” (App. Br., Claim App’x 4-5).
Cox teaches that membrane 4 is retained under “radial compression” which
is “achieved by making the membrane a force fit with the recess 5” (Cox, col. 5, ll.
23-24). Patent Owner contends that Cox does not disclose any relation between
the radial compression and the maximum pressure allowable in the catheter before
leakage into the proximal end of the hub occurs (App. Br. 44). The Examiner finds
that a force fit is an “interference fit that would determine the maximum pressure
allowable prior to leakage” (ACP 21-22).
We agree with Patent Owner that Cox does not expressly disclose a
relationship between the “force fit” of the membrane and the maximum pressure
allowable before leakage. However, “a prior art reference without express
reference to a claim limitation may nonetheless anticipate by inherency.” In re
Omeprazole Patent Litigation, 483 F.3d 1364, 1373 (Fed. Cir. 2007). “Under the
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13

principles of inherency, if a structure in the prior art necessarily functions in
accordance with the limitations of a process or method claim of an application, the
claim is anticipated.” In re King, 801 F.2d 1324, 1326 (Fed. Cir. 1986).
Thus, the issue before us is: does the evidence support the Examiner’s view
that an interference fit would necessarily function to determine the maximum
pressure allowable prior to leakage? We answer this question in the affirmative.
Cox teaches that blood spillage is prevented by the self-sealing action of
membrane 4, which “by virtue of its elastomeric properties is assisted by radial
compression within the annular recess 5 so that the valve means returns to its
closed condition in which the first and second chamber 6 and 7 respectively are
isolated from one another” (Cox, col. 6, ll. 3-5 and col. 5, ll. 7-12). In other words,
Cox teaches that the radial compression of the membrane 4 is what prevents blood
leaking from the distal first chamber 6 to the second proximal chamber 7. We
agree with the Examiner that the interference fit taught by Cox necessarily dictates
the maximum pressure at which blood would leak around the membrane 4. Patent
Owner has not directed us to sufficient rationale or evidence to undermine this
reasoning.
2. OBVIOUSNESS BASED ON COX (Rejections 2 and 30)
Claims 1-3, 6, 22, 23, and 25
The Examiner further rejects claims 1-3 and 6 as obvious over the teachings
of Cox (ACP 3). We need not go into the merits of Patent Owner’s arguments with
respect to the rejection based on our affirmance of the Examiner’s anticipation
rejection above. After all, it is well established that lack of novelty is the ultimate
or epitome of obviousness. In re Fracalossi, 681 F.2d 792, 794 (CCPA 1982)
(“Though the composition might have been obvious, though not anticipated, it
Appeal
Applica
Patent 6

cannot h
establish
obvious
P
and 25 (
Accordi
under 3
Claims
P
and pre
of claim
represen
F
F
element
formed
thicknes
2012-0031
tion 95/00
,699,221 B
ave been
ing lack o
ness.”).
atent Own
Rejection
ngly, we a
5 U.S.C. §
3. OB
1-3 and 6,
atent Own
sents no se
1 (App. B
tative clai
igure 2 of
igure 2 de
14 of the
with a cen
s of the ga
51
0,565
2
anticipated
f all nove
er does no
30), which
ffirm the E
103.
VIOUSNE
16, 24, an
er present
parate arg
r. 14 and
m.
Sylvanow
picts an en
invention
tral apertu
sket 14 (S
and not h
lty in the c
t present a
depend f
xaminer’
SS BASE
(Reject
d 26
s argumen
ument wit
44). Acco
icz is repr
larged sec
of Sylvano
re 46 whic
ylvanowic
14
ave been o
laimed inv
ny argume
rom claim
s rejection
D ON CO
ions 3 and
ts with res
h respect t
rdingly, w
oduced be
tional view
wicz in w
h extends
z, col. 2, l

bvious. T
ention ne
nts with r
1 (see gen
of claims
X AND S
32)
pect to cla
o claims 1
e select cl
low.

of a one-
hich an ou
only to a d
l. 43-45 an
hus evide
cessarily e
espect to c
erally Ap
1-3, 6, 22
YLVANO
ims 1-3 an
6, 24, and
aim 1 as a
piece self
ter half th
epth of ab
d col. 3, l
nce
vidences
laims 22,
p. Br. 43).
, 23, and 2
WICZ
d 6 as a gr
26 over th

-sealing va
ickness 42
out the ha
l. 36-39).
23,

5
oup
at
lve
is
lf
The
Appeal 2012-003151
Application 95/000,565
Patent 6,699,221 B2

15

Examiner concludes that it would have been obvious for one of ordinary skill in
the art to have combined the central aperture of the seal of Sylvanowicz with the
device and membrane of Cox to meet the limitation of a seal with a weakened
central section (ACP 4).
Patent Owner contends that one of ordinary skill in the art would not have
combined the teachings of Cox and Sylvanowicz because the membrane of Cox
does not require a seal against objects directed therethrough, but the seal of
Sylvanowicz teaches a valve capable of sealing against a guidewire or catheter
directed therethrough (App. Br. 13; see Sylvanowicz, col. 4, ll. 7-30). A reference
“teaches away” when it suggests that the developments flowing from its
disclosures are unlikely to produce the objective of the Appellants’ invention. See
In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). We do not agree that the teaching
in Cox directs one of ordinary skill in the art against adding a central aperture that
would seal against objects directed therethrough. To the contrary, Sylvanowicz
discloses that the valve is capable of sealing against an object directed
therethrough, which is an advantage that would have directed the skilled artisan to
make the modification proposed by the Examiner. “[I]f a technique has been used
to improve one device, and a person of ordinary skill in the art would recognize
that it would improve similar devices in the same way, using the technique is
obvious unless its actual application is beyond his or her skill.” KSR, 550 U.S. at
417.
Patent Owner also contends that the aperture of Sylvanowicz would
“pucker” and not come together in a sealed manner due to the radial compression
on the membrane 4 taught by Cox (App. Br. 13-14). Although a combination of
references would be non-obvious when the combination would produce an
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Patent 6,699,221 B2

16

inoperative device, see McGinley v. Franklin Sports, Inc., 262 F.3d 1339, 1354
(Fed. Cir. 2001), Patent Owner has provided no more than mere speculation,
without evidence, that the radial compression of Cox would not function with the
central aperture of Sylvanowicz. Appellants’ attorney arguments do not take the
place of evidence in the record. In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974).
4. OBVIOUSNESS BASED ON COX AND FISCHELL (Rejection 4)
Claim 17
Claim 17 depends from claim 1 and further recites “a stylet extending
through said weakened section of said seal and said cannula” (App. Br., Claim
App’x 3). The Examiner finds that Fischell evinces that using a stylet with
catheters was well known in the art (ACP 5). According to the Examiner, it would
have been obvious to use a stylet with the catheter of Cox because to do so would
have been no more than the predictable use of a known element according to its
established function (id.)
Patent Owner alleges that “the devices of Cox and Fischell are distinctly
different devices” in that Cox discloses a device for sampling or infusion of liquids
and Fischell discloses a vascular access device (App. Br. 14). Although Patent
Owner identifies that the catheter devices of Cox and Fischell are different, Patent
Owner does not address the Examiner’s specific reasoning articulated in the
rejection or explain why the Examiner’s position is deficient.
To the extent that the Patent Owner is arguing that Cox and Fischell are non-
analogous art, we disagree. “Two criteria have evolved for determining whether
prior art is analogous: (1) whether the art is from the same field of endeavor,
regardless of the problems addressed, and (2) if the reference is not within the field
of the inventor’s endeavor, whether the reference still is reasonably pertinent to the
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17

particular problem with which the inventor is involved.” In re Clay, 966 F.2d 656,
658-59 (Fed. Cir. 1992).
Cox and Fischell both teach catheter devices for intravenous access.
Fischell teaches that its “stylet” is a needle used to penetrate the skin and the
femoral artery so as to allow the device 10 to enter the artery (Fischell, col. 2, l. 60
to col. 3, l. 5). Similarly, Cox teaches “a needle or catheter may be passed through
the duct 11, the membrane 4 and hence through the cannula into the patient” (Cox,
col. 5, ll. 28-33). Thus, Cox and Fischell appear to be from the same field of
endeavor in that they are both directed to passing objects into and out of the vessels
of a patient via a cannula or catheter.

5. ANTICIPATION AND OBVIOUSNESS BASED ON LUTHER
(Rejections 5 and 6)
The Examiner rejects claims 1, 3, 6, 10-14, and 18 as anticipated by, and as
obvious over, the teachings of Luther. For both rejections, Patent Owner presents
arguments with respect to claim 1 and presents no separate argument with respect
to claims 2, 3, 6, 13 and 14 over that of claim 1 (App. Br. 15-20). Patent Owner
presents separate arguments with respect to claim 10 and presents no separate
arguments with respect to claims 11 and 12 over that of claim 10 (App. Br. 17-18
and 20). Accordingly, we select claims 1 and 10 as representative claims.
Claims 1, 3, 6, 13, 14, 18
Figure 3 of Luther is reproduced below.
Appeal
Applica
Patent 6

F
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2012-0031
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Patent 6,699,221 B2

19

claim interpretation discussed above, the phrase “mounted in said bore of said hub”
does not preclude the septum seal from being permanently fixed or disposed in a
recess that defines a portion of a bore. Therefore, Patent Owner’s argument is not
persuasive.
Regarding the septum seal being in circumferentially sealed relation to the
bore and having a weakened central section, Patent Owner merely asserts that these
claim features are not taught by Luther (App. Br. 16). A general allegation that the
art does not teach the claim limitations is no more than merely pointing out the
claim limitations. 37 C.F.R. § 41.67(c)(1)(vii) (“A statement which merely points
out what a claim recites will not be considered an argument for separate
patentability of the claim.”). In any event, such statements do not address the
Examiner’s specific findings and support therefore (see ACP 5, citing Luther, col.
1, ll. 58-61, col. 2, ll. 19-49, and Figures 1-3) articulated in the rejections or
explain why these findings are not supported by the evidence.
Patent Owner also contends that a hub cannot be defined by more than one
fitting part (i.e. proximal end fitting 11 (not shown in Fig. 3 reproduced above) and
distal fitting 20 of Luther), citing portions of the Specification referring to “hub
11” and stating generally that “Figures 1 and 3 illustrate hub 11 as a one piece
member” (App. Br. 16-17) (citing ‘221 patent, col. 1, ll. 50-53, col. 3, ll. 3-9, and
col. 4, ll. 1-5). We discern no reason to conclude that the term “hub” would
necessarily require a structure formed from only one part or fitting, as suggested by
the Patent Owner. The term “hub” commonly is a base by which a needle is
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Patent 6,699,221 B2

20

attached to a device.15 We are not persuaded that the Specification expressly
requires that the term “hub” precludes the two piece structure taught by Luther.
We decline to strictly limit the scope of the claims to the embodiments in the
figures of the ‘221 patent. See Phillips, 415 F.3d at 1323. Patent Owner has
provided no persuasive evidence that the term “hub” should be so limited.
Accordingly, considering the broadest reasonable interpretation of the terms
recited in claim 1, we agree with the Examiner’s findings that that claim 1 of the
‘221 patent reads on the device structure described in Luther. Thus, we affirm the
rejection of claims 1, 3, 6, 13, 14, and 18 as both anticipated by and as obvious in
view of Luther. See Fracalossi, 681 F.2d at 794.
Claims 10-12
Claim 10 depends from claim 1 via claim 6 and further recites “a piercing
ring mounted on said seal for pushing through said weakened section of said seal
in a direction towards said cannula to define a flow path through said seal” (App.
Br., Claim App’x 2). The Examiner finds that Luther teaches a piercing ring 35b
mounted on the seal that functions as recited in claim 10 because Luther teaches
that “a typical plug spacing is about 0-10 mils from the septum” (ACP 7; Luther,
col. 2, ll. 30-34). Patent Owner contends that Luther does not teach that the
piercing ring 35b is mounted on the seal but rather that the plug is “spaced” from
the seal, and, even if spaced 0 mils from the seal, the plug would be contacting but
not “mounted on” the septum 33 (App. Br. 17-18).

15 http://www.merriam-webster.com/medical/hub, accessed June 19, 2012 (“the
enlarged base by which a hollow needle may be attached to a device (as a
syringe)”).
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Patent 6,699,221 B2

21

Based on the interpretation of the term “mounted” discussed above as
generally meaning “supported,” we agree with the Patent Owner that a teaching of
the plug merely contacting the septum seal is not a teaching that the plug is
supported by the seal.
However, the Examiner alternatively concludes that it would have been
obvious to mount the plug 35b on the septum seal 33 so that the plug will remain in
contact with the septum (ACP 7). Patent Owner contends that there would be no
rationale to mount the plug on the septum seal because Luther teaches that the plug
is spaced from the seal (App. Br. 20).
The Examiner has provided a sufficient reasoning as to why the skilled
artisan would use the seal to support the plug taught by Luther, namely, to provide
that the plug remains in contact with the seal (ACP 7). Patent Owner has not
addressed the Examiner’s reasoning nor directed us to any rationale or evidence by
which we would determine the Examiner’s reasoning to be unsound.
Patent Owner’s further arguments directed to the obviousness rejection of
claim 10 based on Luther discuss “membrane opener 120” and “membrane 110,”
which appears to be arguments directed to prior art other than Luther.
Accordingly, we reverse the Examiner’s rejection of claims 10-12 based on
anticipation by Luther, but we affirm the Examiner’s rejection of claims 10-12
based on obviousness in view of Luther.

6. OBVIOUSNESS BASED ON VAN HEUGTEN AND LUTHER
(Rejection 14)
The Examiner rejects claims 1-3, 6, 10-15, and 20 as obvious over Van
Heugten and Luther. Patent Owner presents with arguments respect to claim 1 and
Appeal
Applica
Patent 6

presents
claim 1
to claim
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2012-0031
tion 95/00
,699,221 B
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Appeal 2012-003151
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23

describes “a septum seal mounted in said bore of said hub in a circumferentially
sealed relation” and does the evidence support the Examiner’s conclusion that one
of ordinary skill in the art would have modified the membrane 110 of Van Heugten
with the weakened central section of Luther? We answer both of these questions
in the affirmative.
The Examiner finds that membrane 110 is “mounted in said bore of said hub
in circumferentially sealed relation” (ACP 12). Patent Owner contends that
membrane 110 is not “mounted in said bore of said hub” because it is “has an outer
periphery sandwiched between the catheter hub 52 and a proximal portion 56”
(App. Br. 24 and 27). Based on the claim interpretation discussed above, the
phrase “mounted in said bore of said hub” does not preclude the septum seal from
being permanently fixed, disposed in a recess that defines a portion of a bore, or
sandwiched between two pieces that define a hub. Accordingly, we are not
persuaded by Patent Owner’s argument.
Regarding the septum seal being in circumferentially sealed relation to the
bore, Patent Owner merely asserts that these claim features are not taught by Van
Heugten (id.). A general allegation that the art does not teach the claim limitations
is no more than merely pointing out the claim limitations. See 37 C.F.R. §
41.67(c)(1)(vii). In any event, such statements do not address the Examiner’s
specific findings and support therefore (see ACP 12, citing Van Heugten, col. 1, ll.
4-27, col. 2, ll. 45-50, col. 3, l. 59-col. 4, l. 49, and Figures 2, 3, and 4a-4c)
articulated in the rejections or explain why the Examiner’s findings are not
supported by the evidence.
Patent Owner contends that the Y-shaped slit 34 of Luther would
compromise the sealability of membrane 110 of Van Heugten. According to
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24

Patent Owner, Luther does not require the Y-shaped slit 34 to be sealable against
objects directed therethrough, as Luther does not disclose an object that passes
through gasket 33 or to seal against the introducer needle (see generally Luther),
and Van Heugten discloses that the seal is sealed prior to piercing by an introducer
needle (see Van Heugten, col. 4, ll. 7-30). (App. Br. 27-28).
We do not agree that Van Heugten directs one of ordinary skill in the art
against adding the Y-shaped slits of Luther merely because the central portion of
Luther does not require an initial piercing by a needle. Both Luther and Van
Heugten teach that the seal must be resealable and one-directional to prevent the
flow of blood out of the catheter (see Van Heugten, col. 4, ll. 6-29; Luther, col. 1,
ll. 32-44). We agree with the Examiner that the use of the Y-shaped slits 34 of
Luther would be a predictable use of a known resealable one-way valve according
to its established function of preventing backflow of blood from a catheter. See
KSR, 550 U.S. at 417 (The question to be asked is “whether the improvement is
more than the predictable use of prior art elements according to their established
functions.”).
Further, Patent Owner argues that, because Luther does not teach gasket 33
seals against an element passing therethrough, one skilled in the art would find no
teaching in Luther “to place an inverted Y-shaped slit in the membrane 110 of Van
Heugten that is to seal against an introducer needle 24” (App. Br. 27-28). Patent
Owner’s argument presupposes that Van Heugten requires a membrane 110 to seal
against introducer 24. However, Patent Owner directs us to no persuasive
evidence that Van Heugten requires a seal against the introducer needle 24, and we
find no such requirement in the teachings of Van Heugten. Rather, we find that
Van Heugten teaches against a tight seal against the needle in that it teaches a
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25

‘“duck-bill’ valve or valve of similar configuration” as an example of a valve that
provides “no frictional drag on needle 24 during its retraction from the catheter 50”
(Van Heugten, col. 4, ll. 19-27).

Claim 10-12
In addition to those arguments discussed above with respect to the
anticipation and obviousness rejections of claim 10 based on Luther, Patent Owner
contends (a) that neither plug 35b of Luther nor membrane opener 120 of Van
Heugten “pass through” the respective seals and (b) that if membrane opener 120
were mounted on membrane 110, the opener 120 would not be able to deform
member 110 because the membrane 110 needs to slide relative to the membrane
opener 110 in order to be opened (App. Br. 28).
Patent Owner equates the phrase “for pushing through” with “pass through,”
suggesting that claim 10 requires an express teaching that the piercing ring is
pushed so as to fully pass through the seal. Patent Owner’s interpretation of claim
10 does not comport with the broadest reasonable interpretation of claim 10.
Claim 10 recites “a piercing ring mounted on said seal for pushing through said
weakened section of said seal in a direction towards said cannula to define a flow
path through said seal” (App. Br., Claim App’x 2) (emphasis added).
We conclude that the express language of claim 10 requires that the piercing
ring “push through” the seal only to the extent that it defines a flow path through
said seal. Patent Owner has directed us to no evidence or reasoning for us to
import a requirement for the piercing ring to fully “pass through” the seal. We
agree with the Examiner that piercing ring 35 of Luther functions to push through
the seal far enough that such a flow path is defined (see Figure 1).
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Further, Patent Owner has directed us to no evidence in support of the
contention that the plug 35b or opener 120 would not function if “mounted,” or
supported, by the respective seals of Luther and Van Heugten. Attorney arguments
do not take the place of evidence in the record. Pearson, 494 F.2d at 1405.

Claim 15
Claim 15 depends from claim 1 and further requires “a needle hub
telescopically mounted in said bore of said first hub and an introducer needle fixed
in said needle hub and extending through said seal in a sealed relation and through
said cannula” (App. Br., Claim App’x 3).
The Examiner finds that Van Heugten teaches a needle hub 20 telescopically
mounted in the bore of the first hub with an introducer needle 24 fixed therein
(ACP 13). Patent Owner disagrees and contends that Van Heugten does not teach
a needle hub mounted in hub 52 nor an introducer needle fixed in a needle hub
(App. Br. 29). Once again we turn to the broadest reasonable interpretation of the
term “mounted.” As discussed above, we interpreted “mounted” as generally
meaning “supported.” There is no requirement that the needle hub be directly
supported by the hub. As such, Van Heugten teaches that the needle hub 20 (i.e.,
the portion which holds the needle 24 in place) is indirectly supported by hub 52
via the telescopic contact of needle guard tip 60 and hub 52 (see e.g., Van Heugten,
col. 2, ll. 50-55 and Figure 2). Patent Owner has failed to explain why the
Examiner’s finding would not meet the requirements of claim 15.
Alternatively, the Examiner concludes that it would have been obvious to
the skilled artisan to design needle hub 20 and needle guard tip 60 in one unit or so
that the needle guard tip 60 and needle hub 20 are mounted in the hub 52 (ACP
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14). Patent Owner argues that making the structure unitary would be contrary to
the teachings of Van Heugten, which discloses a separate needle guard tip 60.
However, Patent Owner directs us to no teaching in Van Heugten that would deter
the skilled artisan from combining the tip guard 60 and needle hub 20 into a single
structure, as Patent Owner has directed us to no persuasive evidence to indicate
that these two components are required to be separate. The reasons for the skilled
artisan to combine separate structures into a single structure may include, for
example, the reduced cost of forming a one piece structure rather than two. See In
re Thompson, 545 F.2d 1290, 1294 (CCPA 1976) (motivation may be found in
economic factors alone).

Claim 20
Independent claim 20 requires a male luer adaptor “being sized to engage
and push said piercing ring through said slit in said seal to communicate said
adaptor with said cannula” (App. Br., Claim App’x 4). Based on this language,
Patent Owner presents substantially the same arguments discussed above with
respect to claim 10 (App. Br. 29-30).
We do not find Patent Owner’s arguments persuasive for the reasons
discussed above. Moreover, we note that the quoted language of claim 20 is
directed only to the size of the male luer adaptor, not to any structural requirements
of the piercing ring or the seal. Accordingly, we agree with the Examiner that both
Van Heugten and Luther teach male luer adaptor of a size capable of performing
the claimed function. Patent Owner presents no arguments regarding the described
size of the male luer adaptors of Van Heugten and Luther.

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28

7. OBVIOUSNESS BASED ON VAN HEUGTEN, LUTHER, AND
VAILLANCOURT ‘728 (Rejection 26)
The Examiner rejects claims 21 and 33 as obvious over Van Heugten,
Luther, and Vaillancourt ‘728. Patent Owner presents arguments with respect to
claim 21, but presents no separate argument with respect to claim 33 over that of
claim 20 (App. Br. 42). Accordingly, we address claim 21, but affirm the rejection
of claim 33 for the reasons discussed above with respect to claim 20.
Claim 21
Claim 21 depends from claim 1 and further requires that the “seal is
compressed approximately 6% to provide a leakage pressure exceeding 10 psi”
(App. Br., Claim App’x 4).
Vaillancourt ‘728 teaches that a seal with “an initial compression of 5% to
10% of its outer diameter and made of a thickness of 0.050 inches may be pierced
over twenty five times with no leakage once subjected to 30 psig air pressure”
(Vaillancourt ‘728, col. 2, ll. 60-64). Further, Van Heugten teaches that blood
flowing out of the body has an approximate pressure of 2 psi and that “membrane
110 is configured so that it withstands outwardly directional flow of blood greater
than about 3 psi or well above the normal human limit” (Van Heugten, col. 4, ll.
14-18). The Examiner concludes that it would have been obvious to one of
ordinary skill in the art that a radial compression of the seal should be at least 6%
to predictably result in a desirable leakage pressure over 10 psi (ACP 20).
Patent Owner argues that Van Heugten does not teach that valve membrane
110 is or can be radially compressed or that such a compression results in a desired
leakage pressure over 10 psi (App. Br. 41-42). Additionally, Patent Owner
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29

contends that the Examiner presents no evidence to support this position. (App.
Br. 41.)
We are not persuaded by Patent Owner’s arguments. “[I]f a technique has
been used to improve one device, and a person of ordinary skill in the art would
recognize that it would improve similar devices in the same way, using the
technique is obvious unless its actual application is beyond his or her skill.” KSR,
550 U.S. at 417. Van Heugten teaches a desire to provide a seal that can withstand
pressures “well above the normal human limit” of 2 psi. Vaillancourt ‘728 teaches
that one way to achieve a seal that can withstand pressures up to 30 psi is to
provide radial compression of 5-10%. Accordingly, the Examiner’s position is
supported by the evidence of record. In contrast, Patent Owner has not provided
sufficient evidence or reasoning that modifying the seal of Van Heugten by
applying a radial compression of up to 10%, as taught by Vaillancourt ‘728, is
beyond the skill of an ordinary artisan.

8. OBVIOUSNESS BASED ON VAN HEUGTEN, LUTHER, AND COX
(Rejections 40 and 42)
The Examiner rejects claims 34 and 36 as obvious over Van Heugten,
Luther, and Cox. The Examiner further rejects claim 37 as obvious over Van
Heugten, Luther, Cox, and Sylvanowicz.
With respect to claim 34, Patent Owner relies on the same arguments
discussed above with respect to the rejection of claim 23 as anticipated by Cox,
i.e., that an interference fit would determine the maximum pressure allowable prior
to leakage (App. Br. 47).
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With respect to claims 36 and 37, Patent Owner presents no arguments over
those presented above with respect to claim 20 as obvious over Van Heugten in
view of Luther (App. Br. 47-48).
For the reasons discussed above with respect to claims 23 and 20, we affirm
the Examiner’s rejection of claims 34, 36, and 37.

9. OBVIOUSNESS BASED ON VAN HEUGTEN, LUTHER, AND
SYLVANOWICZ (Rejection 41)
Claim 35
Claim 35 depends from claim 20 and further recites that the seal “has an
internal recess defining a weakened central section” (App. Br., Claim App’x 4).
Patent Owner contends that one of ordinary skill in the art would not have
combined the teachings of Van Heugten or Luther and Sylvanowicz because the
membrane of Luther and Van Heugten do not require a seal against objects
directed therethrough, whereas the seal of Sylvanowicz includes a valve capable of
sealing against a guidewire or catheter directed therethrough (App. Br. 22, 25, and
47-48). We do not agree that Luther or Van Heugten directs one of ordinary skill
in the art against adding a central aperture that would seal against objects directed
therethrough. To the contrary, Sylvanowicz’s disclosure that the valve is capable
of sealing against an object directed therethrough is an advantage that would have
directed the skilled artisan to make the modification proposed by the Examiner.
See KSR, 550 U.S. at 417.
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31

10. OBVIOUSNESS REJECTIONS BASED ON VAILLANCOURT ‘766
(Rejections 16, 17, 34, 36, and 38)
The Examiner rejects claims 1-4, 6-9, 15, 19, and 27-30 as obvious over
Vaillancourt ‘766. Patent Owner presents arguments with respect to claim 1 and
presents no separate argument with respect to claims 2, 3, 6, 9 and 15 over that of
claim 1 (App. Br. 36-37). Patent Owner presents separate arguments with respect
to claims 4, 7, 8, 19, 27 and 29 (App. Br. 28-30, 32-33, and 45-46). Patent Owner
presents no separate arguments with respect to claims 28 and 30 over that of claim
19 (App. Br. 45-46). Accordingly, we select claims 1, 4, 7, 8, 19, 27 and 29 as
representative claims.
The Examiner further rejects claims 1-9, 15, and 19 as obvious over
Vaillancourt ‘766 in view of Vaillancourt ‘891. Patent Owner makes substantially
identical arguments with respect to claims 1, 4, 7, 8, and 19, and presents no
arguments with respect to claim 5 over those presented with respect to claim 1.
Accordingly, claim 5 stands or falls with claim 1.
The Examiner further rejects claim 31 as obvious over Vaillancourt ‘766 in
view of Cox and claim 32 as obvious over Vaillancourt ‘766 in view of Cox and
Sylvanowicz. For both of these rejections, the Patent Owner presents no
arguments over those presented with respect to claim 19. Accordingly, claims 31
and 32 stand or fall with claim 19.

Claims 1, 2, 3, 5, 6, 9 and 15
Figure 3 of Vaillancourt ‘766 is reproduced below.
Appeal
Applica
Patent 6

F
having a
engages
col. 3, l
P
in claim
“septum
member
relation
T
claim 1
describe
sealed r
P
a “septu
is also n
Specific
describi
tubular
2012-0031
tion 95/00
,699,221 B
igure 3 of
valve me
the wall i
l. 32-33 an
atent Own
1 are disc
seal” as p
55 is spac
” (App. Br
he issue b
, does the e
s “a septu
elation”?
atent Own
m seal” w
ot express
ation refer
ng the sep
portion 17
51
0,565
2
Vaillancou
mber 55 w
n chamber
d col. 6, ll
er contests
losed in V
ostulated
ed from th
. 31).
efore us is
vidence s
m seal mo
We answe
er contend
ithout prov
ly defined
ring to the
tum seal 1
which fits
rt ‘766 de
ith an out
section 16
. 51-68).
the Exam
aillancour
by the Exa
e hub wal
: Under a
upport the
unted in sa
r this ques
s that the
iding a de
in the ‘22
septum s
6 as “of ge
over the t
32
picts a sec
wardly ext
in an inte
iner’s find
t ‘766, nam
miner and
l 15 and th
proper int
Examiner
id bore of
tion in the
valve mem
finition of
1 patent. P
eal and inc
nerally T-
ube 15 in

tional view
ending an
rference f
ing that c
ely that v
that the v
us not “in
erpretation
finding th
said hub
affirmativ
ber 55 of
the term.
atent Ow
luding ref
shaped co
a stretch-f
of a cath
nular flang
it (Vaillan
ertain limi
alve mem
alve end 3
a circumf
of the lan
at Vaillan
in a circum
e.
Vaillancou
The term
ner cites p
erences to
nstruction
it manner”

eter assem
e 52 that
court ‘766
tations rec
ber 55 is n
1 of valve
erentially
guage of
court ‘766
ferentially
rt ‘766 is
“septum s
ortions of
Figure 2
having a
and “a ca
bly
,
ited
ot a

not
eal”
the
p
Appeal 2012-003151
Application 95/000,565
Patent 6,699,221 B2

33

15 integral with the tubular portion” (App. Br. 31-32) (citing col. 1, ll. 54-56, col.
2, ll. 32-36, and col. 3, ll. 12-16, 19-22, and 35-37).
We discern no reason to conclude that the phrase “septum seal” would
necessarily require a seal having the particular shape illustrated in the Figures of
the ‘221 patent, as suggested by the Patent Owner. The term “septum” commonly
means “a dividing wall separating two spaces.”16 We are not persuaded that the
Specification of the ‘221 patent excludes a seal of the shape described in
Vaillancourt ‘766, which similarly functions as a wall that divides hub 10 into a
proximal chamber 11 and a distal chamber. We decline to strictly limit the scope
of the claims to the embodiments in the figures of the ‘221 patent. See Phillips,
415 F.3d at 1323.
The Examiner finds that valve member 55 is “mounted in said bore of said
hub in circumferentially sealed relation” (ACP 15). While admitting that valve
member 55 “has an enlarged support end 56 that contacts a chamber wall 15 in a
friction fit” (App. Br. 30-31), Patent Owner contends that valve member 55 is not
“mounted in said bore of said hub in a circumferentially sealed relation” because
near end 31 is spaced from the hub wall 15 (App. Br. 32). Based on the claim
interpretation discussed above, the phrase “mounted in said bore of said hub” does
not preclude the septum seal from being supported circumferentially at one end
and extended freely into space at another end. Vaillancourt ‘766 teaches that the
“outer periphery [i.e., circumference] of the support end of valve member 55

16 http://www.merriam-webster.com/medical/septum, accessed June 24, 2012 (“a
dividing wall or membrane especially between bodily spaces or masses of soft
tissue”).
Appeal
Applica
Patent 6

contacts
col. 6, l
A
“mount
1 of the

Claim 4
C
mounte
member
member
between
Vaillanc
RAN 17
F
valve m
and axia
‘766, co
2012-0031
tion 95/00
,699,221 B
chamber
l. 64-66).
ccordingly
ed” recited
‘221 paten

laim 4 dep
d in said b
55 is slid
55 axially
the thicke
ourt ‘776
-18) (citin
igure 2 de
ember 30
lly collap
l. 3, ll. 29
51
0,565
2
wall in a f

, consider
in claim
t reads on
ends from
ore” (App
ably moun
collapses
r end sect
reproduce
g Vaillanc
picts a sec
shown wit
sing the va
-31 and co
riction fit
ing the br
1, we agree
the devic
claim 1 a
. Br., Claim
ted in that
along the
ions of the
d below w
ourt ‘766,
tional view
h a male lu
lve memb
l. 5, ll. 47-
34
[i.e., sealed
oadest reas
with the
e structure
nd further
App’x 1
Vaillanco
relatively
valve me
ith respect
col. 6, l. 6
of a cath
er adapte
er 30 arou
51). Vaill

relation]
onable int
Examiner’
described
requires th
). The Ex
urt ‘766 te
thin-walle
mber, as il
to valve m
8 to col. 7
eter assem
r 40 insert
nd insert m
ancourt ‘7
” (Vaillanc
erpretatio
s finding t
in Vaillan
at the “se
aminer fin
aches that
d section
lustrated i
ember 30
, l. 4).
bly having
ed into the
ember 20
66 teaches
ourt ‘766
n of the ter
hat that cl
court ‘766
al is slidab
ds that val
valve
54 existing
n Figure 2
(ACP 15

a similar
catheter h
(Vaillanc
that valv
,
m
aim
.
ly
ve

of
;
ub
ourt
e
Appeal 2012-003151
Application 95/000,565
Patent 6,699,221 B2

35

member 55 of the embodiment of Figure 3 (above) axially collapses similar to
valve member 30 in Figure 2 (Vaillancourt ‘766, col. 6, l. 68 to col. 7, l. 3).
Patent Owner’s arguments focus on the fact that the valve end 31 of valve
member 30 in Figure 2 (or 55 in Figure 3) is not mounted in the bore and that
support end 56 (Figure 3) is not described as slidably mounted, but rather is fixed
in place (App. Br. 33). Patent Owner further states “[l]ikewise, the collapsible
thin-walled section 54 of the valve member 55 [or 30 in Figure 2] cannot be read
as slidably mounted in the hub 10” (id.). Patent Owner’s arguments focus on the
fact that the various portions of valve member 55, i.e., support end 56, valve end
31, and the thin-walled section 54, individually cannot meet the requirements of
claim 4. However, Patent Owner fails to address the fact that the Examiner finds
the mounting and axial movement of valve member 55, as a whole, meets the
requirements of the claim 4. Accordingly, we are unconvinced that the Examiner’s
position, which is based on sufficient rational underpinnings, is improper.

Claim 7
Claim 7 depends from claim 1 via claim 6 and further requires “a tube
mounted in said weakened section of said seal and extending into said cannula”
(App. Br., Claim App’x 2). The Examiner finds that insert member (tube) 20
disclosed in Vaillancourt ‘766 is mounted in the weakened section 37 of valve end
31 of valve member 30 in Figure 2 and extends into the cannula 19 (ACP 15; RAN
18).
Patent Owner, referencing Figure 1, contends that valve member 30 is
axially and radially spaced from insert member 20 and, thus, cannot be mounted
thereon (App. Br. 33-34).
Appeal 2012-003151
Application 95/000,565
Patent 6,699,221 B2

36

The Examiner reasonably finds that the claim 7 reads on the valve member
when the luer adaptor 40 is inserted into hub 10, as illustrated in Figure 2, when
valve member 55/30 is axially collapsed onto, and thus supported by, tube 20. We
see no reason to read the requirements of claim 7 to exist only when no luer
adaptor is present, and Patent Owner has provided no evidence or reasoning for us
to do so.

Claim 8
Claim 8 depends from claim 1 via claims 6 and 7 and further requires the
seal to have “a tubular portion receiving said tube in a stretch fit manner” (App.
Br., Claim App’x 2). As shown in Figure 2, weakened section 37 of the valve end
31 of valve member 30, is tubular and provided in a stretch fit manner over inner
tube 20 (see Figure 2).
As with claim 7 above, Patent Owner’s arguments are based on Figures 1
and 3 in which the luer adaptor 40 has not yet been applied (App. Br. 36).
Again, the Examiner reasonably finds that the claim 8 reads on the valve
member when the luer adaptor 40 is inserted into hub 10, as illustrated in Figure 2,
when a tubular portion of valve member 55 receives tube 20 in a stretch fit manner.
We discern no reason to read the requirements of claim 8 to exist only when no
luer adaptor is present, and Patent Owner has provided no evidence or reasoning
for us to do so.

Claim 19, 28 and 30-32
With respect to independent claim 19, Patent Owner provides an additional
argument that Vaillancourt ‘766 does not teach a “bloodless” catheter because
Appeal 2012-003151
Application 95/000,565
Patent 6,699,221 B2

37

blood would be allowed to pass into the space between insert member tube 20 and
the valve member 30/55 and would be retained even in the axially collapsed state
of Figure 2 (App. Br. 34). According to the Patent Owner, an advantage of the
structure of the catheter of claim 19 is that the blood may only travel in tube 15 to
the seal and never enters hub 11 even after the seal is opened by the luer connector
21 (id.).
Patent Owner’s interpretation contrasts the language of claim 19, which does
not recite the term “bloodless” and expressly requires a sealed relation “to prevent
a flow of fluid from said cannula to said proximal end of said hub” (App. Br.,
Claim App’x 3) (emphasis added). We note that claim 19 does not expressly recite
that fluid be prevented from leaving the tube or cannula. We find that Vaillancourt
‘766’s valve member 55 prevents fluid from reaching the proximal end of the hub,
and Patent Owner does not argue otherwise.

Claim 27
Claim 27 depends from claim 1 via claims 6 and further states that a “first
means [i.e., a tube] extends from said cannula to said seal” (App. Br., Claim App’x
5). The Examiner finds that, as shown in Figure 2, when axially collapsed, inner
tube 20 extends from valve member 55 to cannula 19 (ACP 22).
As with claim 7 and 8 above, Patent Owner’s arguments are based on
Figures 1 and 3 in which the luer adaptor 40 has not yet been applied (App. Br.
36).
Again, it is reasonable to find that the claim 27 reads on the valve member
when the luer adaptor 40 is inserted into hub 10, as illustrated in Figure 2, when a
tubular portion of valve member 55 receives tube 20. We discern no reason to
Appeal 2012-003151
Application 95/000,565
Patent 6,699,221 B2

38

interpret the requirements of claim 27 to exist only when no luer adaptor is present,
and Patent Owner has provided no evidence or reasoning for us to do so.

Claim 29
Claim 29 depends from claim 19 and further requires that the “seal is sealed
in an interference fit manner to said bore of said hub, said interference fit
determining the maximum pressure allowable in said catheter before leakage into
said proximal end of said hub occurs” (App. Br., Claim App’x 5).
Patent Owner contends that Vaillancourt ‘766 does not disclose that there is
any interference fit that determines the maximum pressure allowable in the catheter
before leakage into the proximal end of the hub occurs (App. Br. 45). The
Examiner finds that Vaillancourt ‘766 teaches an “interference fit that would
determine the maximum pressure allowable prior to leakage” (ACP 22-23).
We agree with Patent Owner that Vaillancourt ‘766 does not expressly
disclose a relationship between the “interference fit” of the valve member 55 and
the maximum pressure allowable before leakage. However, we agree with the
Examiner that the relationship is inherently disclosed in Vaillancourt ‘766.
Vaillancourt ‘766 teaches that blood spillage is prevented by the open
support end of valve member 55 engaging the side wall of the catheter hub, which
“seals off the insert inlet end from the entrance to the catheter hub” (Vaillancourt
‘766, col. 2, ll. 53-56). In other words, Vaillancourt ‘766 teaches that the
interference fit is what prevents blood leaking from the distal chamber 33 to the
proximal chamber 11. We agree with the Examiner that the interference fit taught
by Vaillancourt ‘766 necessarily dictates the maximum pressure at which blood
Appeal 2012-003151
Application 95/000,565
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39

would leak around the valve member 55. Patent Owner has directed us to no
persuasive rationale or evidence to undermine this reasoning.

SUMMARY
We affirm the following rejections:
1. Claims 1-3, 6, 23, and 25 under 35 U.S.C § 102(b) as
anticipated by Cox (see Rejections 1 and 31).
2. Claims 1-3, 6, 22, 23, and 25 under 35 U.S.C. § 103(a) as
obvious over Cox (see Rejections 2 and 30)
3. Claims 1-3, 6, 16, 24 and 26 under 35 U.S.C. § 103(a) as
obvious over Cox in view of Sylvanowicz (see Rejections 3 and 32).
4. Claim 17 under 35 U.S.C. § 103(a) as obvious over Cox in view
of Fischell.
5. Claims 1, 3, 6, 13, 14, and 18 under 35 U.S.C § 102(b) as
anticipated by Luther.
6. Claims 1, 3, 6, 10-13, 14, and 18 under 35 U.S.C. § 103(a) as
obvious over Luther.
14. Claims 1-3, 6, 10-15, and 20 under 35 U.S.C. § 103(a) as
obvious over Van Heugten in view of Luther.
16. Claims 1-4, 6- 9, 15, 19, 27-30 under 35 U.S.C. § 103(a) as
obvious over Vaillancourt ‘766 (see Rejections 16 and 34).
17. Claims 1-9, 15, and 19under 35 U.S.C. § 103(a) as obvious over
Vaillancourt ‘766 in view of Vaillancourt ‘891.
26. Claim 21 and 33 under 35 U.S.C. § 103(a) as obvious over Van
Heugten in view of Luther and Vaillancourt ‘728.
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Patent 6,699,221 B2

40

36. Claim 31 under 35 U.S.C. § 103(a) as obvious over
Vaillancourt ‘766 in view of Cox.
38. Claim 32 under 35 U.S.C. § 103(a) as obvious over
Vaillancourt ‘766 in view of Cox and Sylvanowicz.
40. Claims 34 and 36 under 35 U.S.C. § 103(a) as obvious over
Van Heugten in view of Luther and Cox.
41. Claim 35 under 35 U.S.C. § 103(a) as obvious over Van
Heugten in view of Luther and Sylvanowicz.
42. Claim 37 under 35 U.S.C. § 103(a) as obvious over Van
Heugten in view of Luther, Cox, and Sylvanowicz.
We reverse the rejection of claims 10-12 under 35 U.S.C § 102(b) as
anticipated by Luther (see Rejection 5). We do not address the merits of the
remaining Examiner’s rejections, namely Rejections 7-13, 15, 20-25, 27, 28, and
33.
TIME PERIOD FOR RESPONSE
Requests for extensions of time in this inter partes reexamination
proceeding are governed by 37 C.F.R. § 1.956. See also 37 C.F.R. § 41.79.

AFFIRMED

cu