Ex Parte Hudak

Board of Patent Appeals and Interferences

Jan 31, 2007

09915494 (B.P.A.I. Jan. 31, 2007)

The opinion in support of the decision being entered today was not written
for publication and is not binding precedent of the Board.

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte ROBERT T. HUDAK
__________

Appeal 2006-2699
Application 09/915,494
Technology Center 1600
__________

ON BRIEF
__________

Before SCHEINER, GRIMES, and LINCK, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This appeal involves claims to a specimen collection device. The
Examiner has rejected the claims for anticipation or obviousness and
provisionally rejected for obviousness-type double patenting. We have
jurisdiction under 35 U.S.C. § 134. We affirm the provisional double
patenting rejection, but reverse the anticipation and obviousness rejections.
BACKGROUND
The specification describes “a specimen collection device that
includes a chamber . . . capable of collecting a specimen. The device also
Appeal No. 2006-2699
Application No. 09/915,494

includes a reservoir . . . capable of receiving a portion of the specimen from
the chamber and optionally . . . capable of receiving a test device. The
device optionally includes a valve functionally interposed between the
chamber and the reservoir that is capable of transferring at least a portion of
the specimen from the chamber to the reservoir.” (Specification 1.)
The valve “functions so as [to] acquire a measured portion of a
specimen . . . collected in the chamber”; to “physically separate[] the
measured portion of the specimen from the specimen remaining in the
chamber”; and “to deliver and dispense the measured portion of the
specimen into the reservoir.” (Id. at 17-18.) The specification describes
embodiments in which “the means . . . for transferring a portion of the
specimen in the valve . . . cannot be . . . actuated more than once.” (Id. at
20.)
DISCUSSION
1. CLAIMS
Claims 74-102 are on appeal. We will focus on claim 74, which is
representative and reads as follows:
74. A specimen collection device, comprising:

(a) a chamber for collecting a specimen;

(b) a reservoir for receiving an aliquot of specimen from the
chamber and for receiving a test device;

(c) a valve functionally interposed between the chamber and
the reservoir and having a compartment for holding an aliquot
of specimen and transporting the aliquot from the chamber to
the reservoir, the valve having first, second and third positions,

2
Appeal No. 2006-2699
Application No. 09/915,494

wherein

when the valve is in the first position, the valve compartment is
in fluid communication with the chamber and is not in fluid
communication with the reservoir;

when the valve is in the second position, the valve compartment
is not in fluid communication with the chamber nor the
reservoir;

when the valve is in the third position, the valve compartment is
in fluid communication with the reservoir and is not in fluid
communication with the chamber; and

the valve being inoperable after a first actuation.

Thus, claim 74 is directed to a specimen collection device comprising
a specimen-collection chamber, a reservoir, and a valve having a
compartment for transporting an aliquot of specimen from the chamber to
the reservoir. The valve has a first position in which the valve compartment
is in fluid communication with the chamber and not the reservoir, a second
position in which the valve compartment is not in fluid communication with
the chamber or the reservoir, and a third position in which the valve
compartment is in fluid communication with the reservoir and not the
chamber.
Claim 74 also states that the valve is “inoperable after a first
actuation.” We interpret this limitation to mean that once the valve is moved
from the first position to the second position, the valve becomes inoperable,
such that it cannot transport a second aliquot of specimen from the chamber
to the reservoir.
3
Appeal No. 2006-2699
Application No. 09/915,494

2. ANTICIPATION
Claims 74, 75, 79, 85-92, and 94-102 stand rejected under 35 U.S.C.
§ 102(e) as anticipated by Cui.1 The Examiner states that Cui describes a
device for collecting and testing a fluid specimen, the device having “a first
compartment (chamber) for fluid collection”; “a second compartment
(reservoir) for receiving a portion of the fluid”; and “a valve interposed
between the first compartment and the second compartment (Fig. 1 and Fig.
9).” (Answer 3-4.) The Examiner argues that the “valve comprises a well
(22) (compartment) for holding an aliquot of the specimen” and that “the
second compartment (reservoir) is spaced to allow receipt of a test device
such as a test strip (col 5).” (Answer 4.)
The Examiner also argues that, in Figure 2, Cui depicts a valve
comprising “a well (valve compartment) in fluid communication with the
chamber. One skilled in the art would recognize that when the valve is
actuated that the well will be horizontal at the 3:00 . . . position (second
position) (would not be in fluid communication with the chamber or the
reservoir) and then proceed to the 6:00 . . . position in which the well (valve
compartment) would be in fluid communication with the reservoir and not
the chamber.” (Id.)
In addition, the Examiner states that the recitation “‘the valve being
inoperable after a first actuation’ . . . is not given patentable weight because
it is [the] intended use of the valve.” (Id.) The Examiner also argues that,
because Cui discloses “structurally the same device and valve as recited in

1 Cui, U.S. Patent No. 6,576,193 B1, issued June 10, 2003.
4
Appeal No. 2006-2699
Application No. 09/915,494

the instant claims, it is inherent that the device and valve would be capable
of being inoperable after a first actuation.” (Id. at 10.)
Appellant argues that Cui does not disclose a device comprising a
valve that is “inoperable after a first actuation.” (Br. 7. In particular,
Appellant argues that “this limitation is not a mere recitation of intended use
. . . , but represents a specific characteristic of the claimed invention and a
genuine required limitation of the claim that must be evaluated with every
other limitation – the claim requires that the valve be inoperable after a first
actuation.” (Br. 7.)
We agree with Appellant that the recitation that the valve is
“inoperable after a first actuation” is not merely a recitation of intended use.
Instead, this recitation limits the valve to one having a structure that cannot
transport a second aliquot of specimen from the chamber to the reservoir. In
addition, we agree with Appellant that the Examiner has not set forth a
prima facie case that Cui describes a device having such a valve. Thus, the
Examiner has not demonstrated that Cui anticipates claim 74. We therefore
reverse the § 102(e) rejection of claims 74, 75, 79, 85-92, and 94-102.
3. OBVIOUSNESS
Claims 76-78, 80-84, and 93 stand rejected under 35 U.S.C. § 103 as
follows: claim 76 as obvious over Cui in view of Nelson,2 claims 77 and 78
as obvious over Cui in view of Alley,3 claims 80 and 84 as obvious over Cui

2 Nelson, U.S. Patent No. 5,115,934, issued May 26, 1992.
3 Alley, U.S. Patent Publication No. 2002/0046614 A1, published April 25,
2002.
5
Appeal No. 2006-2699
Application No. 09/915,494

in view of Mitsumaki4 and Pampinella,5 claims 81-83 as obvious over Cui in
view of Carter,6 and claim 93 as obvious over Cui in view of Ehrenkranz.7
Claims 76-78, 80-84, and 93 depend from claim 74. We have already
concluded that the Examiner has not set forth a prima facie case that Cui
anticipates claim 74. In addition, the Examiner has not adequately shown
that claim 74 would have been obvious over Cui. The Examiner relies on
Nelson, Alley, Mitsumaki, Pampinella, Carter, and Ehrenkranz for
limitations recited in dependent claims, and has not pointed to any disclosure
in these references that would make up for the deficiencies discussed above.
Thus, we conclude that the Examiner has not set forth a prima facie case that
claims 76-78, 80-84, and 93 would have been obvious. We therefore reverse
the obviousness rejections of these claims.
4. DOUBLE-PATENTING
The Examiner has provisionally rejected claims 74-102 under the
judicially created doctrine of obviousness-type double patenting over
claims 1-62 of U.S. Patent Application No. 10/211,199. Appellant does not
traverse this rejection; therefore, we affirm it.

4 Mitsumaki, U.S. Patent No. 4,680,270, issued July 14, 1987.
5 Pampinella, U.S. Patent Publication No. 2002/0023482 A1, published
February 28, 2002.
6 Carter, U.S. Patent No. 4,909,933, issued March 20, 1990.
7 Ehrenkranz, U.S. Patent No. 4,769,215, issued September 6, 1988.
6
Appeal No. 2006-2699
Application No. 09/915,494

SUMMARY
The Examiner has not adequately shown that the claims are
anticipated or obvious over the applied prior art. We therefore reverse the
anticipation and obviousness rejections. However, we affirm the provisional
double patenting rejection.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 CFR § 1.136(a).

AFFIRMED

Toni R. Scheiner )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
Eric Grimes )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
Nancy J. Linck )
Administrative Patent Judge )

EG/MLM/jlb
7
Appeal No. 2006-2699
Application No. 09/915,494

Fish & Richardson, P.C.
P.O. Box 1022
Minneapolis, MN 55440-1022
8