Ex Parte Vreeke et al

Patent Trial and Appeal Board

Mar 10, 2014

10455012 (P.T.A.B. Mar. 10, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
10/455,012 06/06/2003 Mark S. Vreeke MSE #2653 5331
71331 7590 03/11/2014
NIXON PEABODY LLP
300 S. Riverside Plaza, 16th Floor
CHICAGO, IL 60606-6613
EXAMINER
FOREMAN, JONATHAN M
ART UNIT PAPER NUMBER
3736
MAIL DATE DELIVERY MODE
03/11/2014 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte MARK S. VREEKE, STEVEN C. CHARLTON,
ALAN R. McCLEARY, and BRUCE A. FLORA1
__________

Appeal 2012-001733
Application 10/455,012
Technology Center 3700
__________

Before MELANIE L. McCOLLUM, ERICA A. FRANKLIN, and
ULRIKE W. JENKS, Administrative Patent Judges.

McCOLLUM, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a fluid
collection apparatus. The Examiner has rejected the claims for obviousness
and for lacking written description. We have jurisdiction under 35 U.S.C.
§ 6(b). We affirm.

1 Appellants identify the real party in interest as Bayer Healthcare LLC
(App. Br. 2).
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STATEMENT OF THE CASE
Claims 1, 2, 4, 6-10, 12, 13, 51-60, 62-69, 71-80, and 82 are pending
and on appeal (App. Br. 2). The claims subject to each rejection have not
been argued separately and therefore stand or fall together. 37 C.F.R.
§ 41.37(c)(1)(vii). Claim 1 is representative and reads as follows (emphasis
added):
1. A fluid collection apparatus adapted to test a concentration of an
analyte in a fluid, comprising:
a lid having a lid surface;
a base having a substantially planar base surface, said base surface
and said lid surface facing each other;
a spacer disposed between said lid surface and said base surface;
a capillary channel defined between said lid surface and said base
surface by said spacer, said capillary channel having an opening for
receiving the fluid, said capillary channel being dimensioned to receive the
fluid along the entire length of said capillary channel by capillary action;
and
a lance having a piercing end, said lance being disposed between said
lid surface and said base surface and in said capillary channel, said lance
being movable relative to said base and parallel to said plane of said base
between a first position and a second position, said lance not moving
completely out of said capillary channel, wherein in said second position,
said piercing end of said lance extends beyond said lid and said base for
puncturing and is positioned adjacent said opening of said capillary channel.
Claims 1, 2, 4, 6-10, 12, 13, 51-60, 62-69, 71-80, and 82 stand
rejected under 35 U.S.C. § 112, first paragraph, as failing to comply with the
written description requirement (Ans. 4).
Claims 1, 2, 4, 6, 8-10, 51-56, 58-60, 73-76, 78-80, and 82 stand
rejected under 35 U.S.C. § 103(a) as obvious over Noda (JP 2000-258382 A,
Sept. 22, 2000) in view of Freeman et al. (US 5,938,679, Aug. 17, 1999)
(Ans. 5).
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Claims 7, 57, and 77 stand rejected under 35 U.S.C. § 103(a) as
obvious over Noda in view of Freeman and Smart et al. (US 5,801,057,
Sept. 1, 1998) (Ans. 7).
Claims 12 and 13 stand rejected under 35 U.S.C. § 103(a) as obvious
over Noda in view of Freeman, Smart, and Perez (US 7,264,627 B2, Sept. 4,
2007) (Ans. 8).
Claims 62-69, 71, and 72 stand rejected under 35 U.S.C. § 103(a) as
obvious over Noda in view of Freeman and Perez (Ans. 9).
Claims 1, 2, 4, 6, 8-10, 51-56, 58-60, 73-76, 78-80, and 82 stand
rejected under 35 U.S.C. § 103(a) as obvious over Noda in view of Ikeda et
al. (US 6,051,392, Apr. 18, 2000) (Ans. 12).
Claims 7, 57, and 77 stand rejected under 35 U.S.C. § 103(a) as
obvious over Noda in view of Ikeda and Yassinzadeh et al. (US 5,700,695,
Dec. 23, 1997) (Ans. 14).
Claims 12 and 13 stand rejected under 35 U.S.C. § 103(a) as obvious
over Noda in view of Ikeda, Yassinzadeh, and Perez (Ans. 14).
Claims 62-69, 71, and 72 stand rejected under 35 U.S.C. § 103(a) as
obvious over Noda in view of Ikeda and Perez (Ans. 15).
I
In rejecting the claims for lacking written description, the Examiner
finds:
The claims require a capillary channel being dimensioned to
receive fluid along the entire length of the capillary channel by
capillary action and a lance that does not move (or is prevented
from moving) completely out of the capillary channel.
However, the specification fails to disclose an embodiment
having a capillary channel dimensioned to receive fluid along
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the entire length of the capillary channel by capillary action and
a lance that does not move completely out of the capillary
channel.
(Ans. 5.)
Findings of Fact
1. The Specification discloses:
In the illustrated embodiment, the capillary channel 18 . . .
includes a reagent 19 that will react with the drawn blood in
order to create a measurable reaction. According to one
embodiment, the reagent 19 is disbursed throughout the entire
capillary channel. A lance 24 is disposed in the capillary
channel 18. The lance 24 is moveable through the capillary
channel 18 in a direction parallel to the length of the capillary
channel 18.
(Spec. 5: 31 to 6: 6.)
2. The Specification also discloses:
The operation of the device 10 illustrated in the embodiments
of FIGS. 3-4b will now be described. A user will position the
apparatus such that the second end 22 of the capillary
channel 18 is pressed against the skin. The lance 24 is in a first
position, shown in FIG. 4a, extending out from the first end 20
of the capillary channel 18. The user then pushes the lance 24
downward to a second position shown in FIG. 4b, such that the
lance 24 extends past the second opening 22 of the capillary
channel 18 and enters the skin. The lance 24 is pushed
downward with enough force to create a puncture wound
sufficient to draw blood. . . . Once the lance 24 has punctured
the skin, the user pulls lance 24 out of the skin and up the
capillary channel 18, at least past the reaction area 26. Blood is
drawn into the capillary channel 18 via capillary action. The
reagent 19 in the capillary channel 18 reacts with the blood to
create a reaction that can be measured . . . . In some
embodiments, the capillary channel 18 includes stops (not
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shown) that prevent the lance 24 from being completely pulled
out of the capillary channel 18.
(Id. at 7: 13-28.)
Principles of Law
“An assertion of what seems to follow from common experience is
just attorney argument and not the kind of factual evidence that is required to
rebut a prima facie case of [unpatentability].” In re Geisler, 116 F.3d 1465,
1470 (Fed. Cir. 1997).
Analysis
Representative claim 1 recites a “capillary channel being dimensioned
to receive . . . fluid along the entire length of said capillary channel by
capillary action.” We interpret this language to require a capillary channel
that has the necessary length and width such that, under appropriate
conditions, capillary action could be used to draw at least one fluid along its
entire length.
As noted by the Examiner (Ans. 5), the Specification discloses that
“capillary channel 18 includes stops . . . that prevent the lance 24 from being
completely pulled out of the capillary channel 18” (Finding of Fact (FF) 2).
The question is whether the Specification discloses that capillary channel 18
is dimensioned to receive fluid along its entire length by capillary action.
As noted by Appellants (App. Br. 11), the Specification discloses that
“reagent 19 is disbursed throughout the entire capillary channel” (FF 1).
However, we do not agree that Appellants have adequately shown that the
presence of reagent along the entire capillary channel indicates that “the
capillary channel 18 must be dimensioned to receive fluid along the entire
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length of the capillary channel 18 by capillary action” (App. Br. 11
(emphasis added)).
As also noted by Appellants, “the capillary channel 18 generally has
uniform dimensions along its entire length,” as shown in Specification
Figure 4a (App. Br. 11). However, we conclude that Appellants have not
provided sufficient evidence to support the position that, as a result, capillary
channel 18 is dimensioned to receive fluid along its entire length by
capillary action.
Conclusion
The evidence supports the Examiner’s position that the Specification
fails to describe a capillary channel being dimensioned to receive fluid along
the entire length of the capillary channel by capillary action. We therefore
affirm the written description rejection.
II
In rejecting the claims over Noda and Freeman, alone or in view of
additional references, the Examiner relies on Noda for disclosing many
features of the claimed apparatus (Ans. 5-6). However, the Examiner
acknowledges that “Noda fails to disclose the lance not moving completely
out of the capillary channel” (id. at 6).
The Examiner relies on Freeman for disclosing “a fluid collection
apparatus having a lance (128) movable within a capillary channel (130 . . . )
from a first position (Figure 3A) to a second position (Figure 3C) for
puncturing, wherein the lance does not move completely out of the capillary
channel (Figures 3A - 3E),” and that the “capillary channel is dimensioned
to receive the fluid along the entire length of the capillary channel by
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capillary action in that the capillary channel has a size which receives fluid
by capillary action” (id.). The Examiner concludes that it would have been
obvious “to modify the lance disclosed by Noda to not move completely out
of the capillary channel as taught by Freeman et al. to create a disposable
cartridge to aid in avoiding sanitary problems and danger of infection” (id. at
6-7).
Findings of Fact
3. Freeman Figure 3 is reproduced below:

Freeman Figure 3 depicts a blood sampling device 124 “with an actuator 126
for driving the cutting motion of a blade structure 128, i.e., for penetration
into a tissue such as skin,” and a “housing 130 . . . enclos[ing] the blade
structure 128, except at its distal end, which has an opening 132 for
receiving blood from the patient’s skin” (Freeman, col. 5, ll. 53-61).
4. Freeman discloses that an “optional tube-like stabilizer 140
with a lumen 143 is connected to the housing 130 to confine the blade
structure 128 and limit its lateral movement. The stabilizer 140 can be just
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slightly larger than the support 142 of the blade structure 128, to enable it to
fit therein.” (Id. at col. 6, ll. 5-9.)
5. Freeman also discloses that “capillary action can provide the
primary force to draw the blood up into the housing 130” (id. at col. 6, ll. 29-
30).
6. Freeman Figure 4 is reproduced below:

[Freeman] FIGS. 4A, 4B, 4C, 4D, 4E show the actuation of the
blade structure 128 in a manner similar to that shown in FIG. 3,
including extension and retraction of the blade structure. After
skin penetration (FIG. 4C), the retraction of the blade
structure 128 and plunger 148 creates a suction to draw
blood 150 into the chamber 144 (FIGS. 4D and 4E).
(Id. at col. 6, ll. 35-40.)
Analysis
Appellants argue that “Noda and Freeman, alone or in combination,
fail to teach or suggest a lance that does not move completely out of the
capillary channel, where the capillary channel is dimensioned to receive the
fluid along the entire length of the capillary channel by capillary action”
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(App. Br. 14). We agree that the Examiner has not set forth a prima facie
case of obviousness.
The Examiner relies on Freeman’s housing 130 for being a capillary
channel (Ans. 6). Freeman discloses not moving lance 128 completely out
of housing 130 (FF 3 & 6). However, we agree with Appellants that the
Examiner has not adequately shown that housing 130 is dimensioned to
receive fluid along its entire length by capillary action (App. Br. 15).
Conclusion
The Examiner has not set forth a prima facie case that Noda and
Freeman suggest a lance that does not move completely out of the capillary
channel, where the capillary channel is dimensioned to receive the fluid
along the entire length of the capillary channel by capillary action. We
therefore reverse the obviousness rejections over Noda and Freeman, alone
and in view of additional references.
III
In rejecting the claims over Noda and Ikeda, alone or in view of
additional references, the Examiner relies on Noda as discussed above
(Ans. 12-13). In particular, the Examiner acknowledges that “Noda fails to
disclose the lance not moving completely out of the capillary channel” (id. at
13).
The Examiner relies on Ikeda for disclosing “a fluid collection
apparatus having a lance (25) movable within a capillary channel (26) from
a first position (Figure 3) to a second position (Figure 4a) for puncturing,
wherein the lance does not move completely out of the capillary channel
(Figures 3, 4a[,] 4b),” and that the “capillary channel is dimensioned to
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receive the fluid along the entire length of the capillary channel by capillary
action in that the capillary channel has a size which receives fluid by
capillary action” (id.). The Examiner concludes that it would have been
obvious “to modify the lance disclosed by Noda to not move completely out
of the capillary channel as taught by Ikeda et al. so as to use the lance as a
working electrode and/or for aiding in the collection of the sample by
sticking to the surface of the lance” (id.).
Findings of Fact
7. Ikeda Figure 3 is reproduced below:

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Ikeda Figure 3 depicts a measurement device comprising a main body 20,
wherein a “cylinder 21 of the main body 20 accommodates a cylindrical
needle holder 24,” “has a cap 23 being screwed into one end thereof,” and
“has a cylindrical member 26 detachably fitted at the other end thereof”
(Ikeda, col. 6, ll. 14-23).
8. Ikeda discloses that a needle 25, which “doubles as a working
electrode,” is mounted at a tip of the needle holder 24 and “should be
detached after unscrewing the cap 23 from the main body 20 and taking out
the needle holder 24” (id. at col. 6, ll. 30-34).
9. Ikeda Figures 4a and 4b are reproduced below:

Ikeda “FIG. 4a illustrates a longitudinal cross-sectional view of the . . .
measurement device [in Figure 3] at puncture of the skin, and FIG. 4b
illustrates a longitudinal cross-sectional view of the same measurement
device at measurement” (id. at col. 4, ll. 12-16).
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10. To use the device, Ikeda discloses:
A user presses an opening of the cylindrical member 26 against
the skin of a subject to be examined and pushes a switch 28. As
a result, . . . the needle holder 24 moves toward a downward
direction as shown FIG. 4a . . . . Then, the needle 25 mounted
at the tip of the needle holder 24 is projected from the opening
of the cylindrical member 26 and punctures the skin of the
subject as shown in FIG. 4a. Upon puncture of the skin by the
needle 25, body fluids leak out from the punctured skin.
(Id. at col. 6, ll. 39-49.)
11. Ikeda also discloses that the “body fluids leaking from the skin
penetrate throughout inside the cylindrical member 26 by sticking to the
needle 25 or via the capillary phenomenon” (id. at col. 6, ll. 55-57).
Analysis
With regard to the obviousness rejection over Noda and Ikeda,
Appellants argue that “Noda and Ikeda, alone or in combination, fail to teach
or suggest a lance that does not move completely out of a capillary channel,
where the capillary channel is dimensioned to receive the fluid along the
entire length of said capillary channel by capillary action” (App. Br. 22).
However, Appellants do not dispute the Examiner’s finding that Ikeda
discloses a capillary channel “dimensioned to receive the fluid along the
entire length of the capillary channel by capillary action” (Ans. 16). Instead,
Appellants argue that, “contrary to the claimed invention, Ikeda teaches that
the needle should be completely moved from the main body, and from the
capillary channel in particular” (App. Br. 21-22). We are not persuaded.
Representative claim 1 recites a “lance being movable . . . between a
first position and a second position, said lance not moving completely out of
said capillary channel.” We interpret this language to require that the lance
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be capable of moving from a first to a second position without moving
completely out of the capillary channel. As noted by the Examiner, Ikeda
discloses “a fluid collection apparatus having a lance (25) movable within a
capillary channel (26) from a first position (Figure 3) to a second position
(Figure 4a) for puncturing, wherein the lance does not move completely out
of the capillary channel (Figures 3, 4a[,] 4b)” (Ans. 13; FF 7-10). While we
understand that Ikeda discloses that the needle holder and needle can be
taken out of the device (FF 8), we do not agree with Appellants that claim 1
requires that the lance be incapable of being removed from the capillary
channel. We additionally note that Ikeda discloses that the “body fluids
leaking from the skin penetrate throughout inside the cylindrical member 26
. . . via the capillary phenomenon” (FF 11).
With regard to the obviousness rejections of claims 7, 12, 13, 57, 62-
69, 71, 72, and 77 over Noda and Ikeda in view of Yassinzadeh and/or
Perez, Appellants argue that Noda and Ikeda in view of Yassinzadeh and/or
Perez fail “to teach or suggest a lance that does not move completely out of
the capillary channel, where the capillary channel is dimensioned to receive
the fluid along the entire length of said capillary channel by capillary action”
(App. Br. 23-25). However, for the same reasons we are not persuaded by
Appellants’ argument that Noda and Ikeda fail to suggest this, we are also
not persuaded that Noda and Ikeda in view of Yassinzadeh and/or Perez fail
to suggest this.
Conclusion
The evidence supports the Examiner’s position that Noda and Ikeda
suggest a lance that does not move completely out of a capillary channel,
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where the capillary channel is dimensioned to receive the fluid along the
entire length of the capillary channel by capillary action. We therefore
affirm the obviousness rejections over Noda and Ikeda, alone and in view of
additional references.
SUMMARY
We affirm the written description rejection of claims 1, 2, 4, 6-10, 12,
13, 51-60, 62-69, 71-80, and 82.
We also affirm the obviousness rejections of claims 1, 2, 4, 6, 8-10,
51-56, 58-60, 73-76, 78-80, and 82 over Noda in view of Ikeda, of claims 7,
57, and 77 over Noda in view of Ikeda and Yassinzadeh, of claims 12 and 13
over Noda in view of Ikeda, Yassinzadeh, and Perez, and of claims 62-69,
71, and 72 over Noda in view of Ikeda and Perez.
However, we reverse the obviousness rejections of claims 1, 2, 4, 6, 8-
10, 51-56, 58-60, 73-76, 78-80, and 82 over Noda in view of Freeman, of
claims 7, 57, and 77 over Noda in view of Freeman and Smart, of claims 12
and 13 over Noda in view of Freeman, Smart, and Perez, and of claims 62-
69, 71, and 72 over Noda in view of Freeman and Perez.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

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