Ex Parte Wardlaw

Board of Patent Appeals and Interferences

Jul 31, 2003

09256486 (B.P.A.I. Jul. 31, 2003)

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The opinion in support of the decision being entered
today was not written for publication in a law journal
and is not binding precedent of the Board.
Paper No. 32
UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES

Ex parte STEPHEN C. WARDLAW

Appeal No. 2003-1489
Application No. 09/256,486

ON BRIEF

Before KIMLIN, GARRIS and KRATZ, Administrative Patent Judges.
KIMLIN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal from the final rejection of claims 1-15,
17-20, 22, 23, 28, 29, 31, 33 and 40-44. Claims 21 and 24-27,
the other claims remaining in the present application, have been
allowed by the examiner. Claim 1 is illustrative:
1. A container for holding a biologic fluid sample for
analysis, said container comprising:
a chamber having a first wall and a transparent second wall,
wherein a fluid sample quiescently residing within said chamber
is imageable through said second wall;
Appeal No. 2003-1489
Application No. 09/256,486
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at least one feature operable to enable the analysis of the
biologic fluid, said feature located within said chamber at a
known spatial location; and
a label attached to said container, said label containing
information having utility in said analysis, said information
including said known spatial location.
The examiner relies upon the following references as
evidence of obviousness:
Van Deusen et al. 5,132,097 Jul. 21, 1992
(Van Deusen)
Gavin et al. 5,591,403 Jan. 07, 1997
(Gavin)
O'Bryan et al. 5,623,415 Apr. 22, 1997
(O'Bryan)
Appellant's claimed invention is directed to a container for
holding a biologic fluid sample for the purpose of analyzing the
sample. The container comprises a chamber in which a fluid
sample quiescently resides and is imageable through a transparent
wall. The container also comprises at least one feature, which
is located within the chamber at a known spatial location, that
enables analysis of the biologic fluid. The feature may be a
reagent which reacts with the fluid sample in the chamber
(claim 15), and may further include a through-plane thickness
located at or adjacent the known spatial location (claim 17). In
addition, the container comprises a label containing information
that is useful regarding the analysis, including the spatial
location of the feature.
Appeal No. 2003-1489
Application No. 09/256,486
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Appealed claims 1-6, 8-15, 17-20, 22, 23, 28, 29, 31, 33 and
40-44 stand rejected under 35 U.S.C. § 103 as being unpatentable
over Gavin in view of Van Deusen. Claim 7 also stands rejected
under 35 U.S.C. § 103 as being unpatentable over Gavin in view of
Van Deusen and O'Bryan.
In accordance with the grouping of claims set forth at
page 8 of appellant's principal brief, the following groups of
claims stand or fall together:
(A) claims 1-10, 12-15, 22, 23, 28 and 29;
(B) claim 11;
(C) claim 31;
(D) claim 33; and
(E) claims 17-20 and 40-44.
We have thoroughly reviewed each of appellant's arguments
for patentability. However, we are in complete agreement with
the examiner that the claimed subject matter would have been
obvious to one of ordinary skill in the art within the meaning of
§ 103 in view of the applied prior art. Accordingly, we will
sustain the examiner's rejections for essentially those reasons
expressed in the Answer, and we add the following primarily for
emphasis.
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Application No. 09/256,486
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We concur with the examiner that Gavin, like appellant,
discloses a container for holding a biologic fluid sample for
analysis comprising a chamber having a transparent wall which
contains the sample that is imageable through the transparent
wall. The container of Gavin also comprises the claimed "at
least one feature operable to enable the analysis of the biologic
fluid" (claim 1), such as a reagent disposed in the chamber which
reacts with the sample, and a through-plane thickness located at
the known spatial location that is substantially less than the
lateral expanse of that region of the chamber. In addition, the
container of Gavin comprises a label, or bar code, which contains
useful information for the analysis. While the information on
Gavin's label is not described as including the spatial location
of the reagent, Van Deusen evidences that it was known in the art
to include the spatial location of a reagent on the label of a
testing device. Accordingly, we find no error in the examiner's
legal conclusion that it would have been obvious for one of
ordinary skill in the art to provide such information with a
label on a testing device of the type disclosed by Gavin.
Manifestly, it would be a matter of obviousness for one of
ordinary skill in the art to include all the information on such
Appeal No. 2003-1489
Application No. 09/256,486
1 Page 12 of principal brief, second paragraph.
2 Sentence bridging pages 11 and 12 of principal brief.
3 Page 8 of Answer, first paragraph.
4 Page 12 of principal brief, first paragraph.
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a label that is physically practical and useful for the intended
test.
While appellant acknowledges that "[t]he Examiner correctly
observes that there is no recitation of a means to image the
container within the claim,"1 appellant nonetheless argues that
no imaging is performed by Gavin, "[n]or is it disclosed or
suggested that the container within Gavin includes a chamber
having a wall through which a fluid quiescently residing within
the chamber is imageable."2 We agree with the examiner, however,
that the transparency of Gavin's container renders it "fully
capable of performing the imaging function."3 Appellant, in
response, offers only the conclusion that the examiner's finding
"is unfounded and appears to be the product of impermissible
hindsight,"4 but appellant advances no substantive argument which
provides a rationale why the fluid sample in the transparent
container of Gavin is not capable of imaging. Appellant only
repeats what is acknowledged by the examiner, namely, that
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Application No. 09/256,486
5 Page 12 of principal brief, last sentence.
6 Page 14 of principal brief, first paragraph.
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"[t]here is no disclosure or suggestion that imaging is performed
within Gavin regardless of the type of light source."5
Appellant also maintains that there is no disclosure in
Gavin regarding the known spatial location of the "feature"
(clot-promoting agent 28). However, appellant acknowledges that
Gavin discloses that agent 28 is located between the restricted
areas 42 and the drive apertures 35 of the conduits, and such
disclosure meets the claimed requirement of a feature located
within the chamber at a known spatial location. Also, inasmuch
as appellant's specification defines "feature" as including
physical and geometric characteristics of the chamber, Gavin's
disclosure of restricted area 42 meets the claimed requirement
for such feature.
We are also not persuaded by appellant's argument that
"[n]either Gavin nor Van Deusen disclose [sic, discloses] or
suggest [sic, suggests] a container having a chamber for
quiescently holding a biologic sample, wherein the sample can be
imaged within the chamber."6 Again, appellant has not refuted
the examiner's reasonable finding that the chambers of Gavin are
fully capable of quiescently holding a sample which can be
Appeal No. 2003-1489
Application No. 09/256,486
7 Page 14 of principal brief, last sentence.
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imaged. Whereas appellant goes to great lengths to emphasize
that the "wherein" clause of the claim "describes a
characteristic of the second wall,"7 appellant does not explain
why the transparent wall of Gavin's chamber does not possess this
characteristic.
Regarding the separately argued requirement of claim 11 for
the label containing information for accessing information stored
remotely from the label, we find, as set forth above, that it
would have been obvious for one of ordinary skill in the art to
include all information on the label that is useful in the
process in which the container is used. Certainly, one cannot
patentably distinguish an article from a prior art article by
labeling it with instructions for using the article in a manner
not disclosed by the prior art.
Separately argued claim 31 calls for "at least one feature
includes physical characteristics located at known spatial
locations within a plurality of regions of said chamber, and said
physical characteristics enable the performance of a plurality of
different tests on the biologic fluid sample." We agree with the
examiner that this requirement is met by "Figures 2 and 5 of
Gavin et al. for the teaching of different regions on either side
Appeal No. 2003-1489
Application No. 09/256,486
8 Page 12 of Answer, second paragraph.
9 Id.
10 Page 20 of principal brief, third paragraph.
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of the restriction 42, in the chambers 30-34, which can contain
different reagents 28, 29, 39."8 As explained by the examiner,
"Gavin et al. shows a chamber that includes a plurality of
regions, each region having through-plane thickness that enables
the performance of a plurality of different tests on the
biological sample."9 The examiner's analysis rebuts appellant's
argument that "[t]here is no disclosure of any physical
characteristics within any of the conduits 30-34 that enable the
performance of a plurality of different tests."10 As for
separately argued claim 33, appellant has advanced no reason why
the structure of Gavin's container does not allow for the claimed
iterative performance of a test. The fact that Gavin discloses,
as urged by appellant, that the cuvette 12 can be disposed once a
PT test has been completed does not mean that iterative tests
cannot be performed before disposal. Indeed, as noted by the
examiner, appellant's specification teaches that a distinct
advantage of the claimed container is that it is disposable.
Concerning the recitation in claims 17 and 40 pertaining to
the relative size of the through-plane thickness versus the
Appeal No. 2003-1489
Application No. 09/256,486
11 Sentence bridging pages 23 and 24 of principal brief.
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lateral expanse of a first region of the chamber, we agree with
the examiner's reasoning set forth at pages 14 and 15 of the
Answer. Although appellant submits that "[i]nherency does not
obviate the Examiner's burden of providing a basis in fact and/or
technical reasoning to reasonably support the determination that
the allegedly inherent characteristic necessarily flows from the
teachings of the applied prior art,"11 appellant has failed to
address just such reasoning provided by the examiner. Nor has
appellant provided any reasoning or evidence which demonstrates
that the chambers of Gavin do not meet the claimed relationship
between through-plane thickness and lateral expanse.
As a final point, we note that appellant bases no argument
upon objective evidence of nonobviousness, such as unexpected
results.
In conclusion, based on the foregoing and the reasons well-
stated by the examiner, the examiner's decision rejecting the
appealed claims is affirmed.
Appeal No. 2003-1489
Application No. 09/256,486
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No time period for taking any subsequent action in
connection with this appeal may be extended under 37 CFR
§ 1.136(a).
AFFIRMED
EDWARD C. KIMLIN )
Administrative Patent Judge )
)
)
)
)
BRADLEY R. GARRIS ) BOARD OF PATENT
Administrative Patent Judge ) APPEALS AND
) INTERFERENCES
)
)
)
PETER F. KRATZ )
Administrative Patent Judge )
ECK:clm
Appeal No. 2003-1489
Application No. 09/256,486
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