Ex Parte Fritchie et al

Board of Patent Appeals and Interferences

Sep 14, 2011

11809256 (B.P.A.I. Sep. 14, 2011)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte PATRICK P. FRITCHIE and JOHN CURTIS JONES
__________

Appeal 2010-012460
Application 11/809,256
Technology Center 1600
__________

Before ERIC GRIMES, LORA M. GREEN, and JEFFREY N. FREDMAN,
Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the
Examiner‟s rejection of claims 1-6.
1
We have jurisdiction under 35 U.S.C.
§ 6(b).

1
Claims 7-30 are also pending, but stand withdrawn from consideration
(App. Br. 3; see also Ans. 2).
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Application 11/809,256

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STATEMENT OF THE CASE
Claim 1 is the only independent claim on appeal, and reads as follows:
1. A method for arranging assays in an order for execution in a system
that employs a plurality of clinical analyzers and carrying out said
assays after said assays are arranged in said order for execution, said
method comprising the steps of:
(a) prioritizing the order of execution of a number of individual assays in
a set of assays for a given sample in an original sample container, the
priority of an individual assay in the set of assays for the given sample
being specified by the sensitivity of the individual assay, wherein
there is at least one sample-to-sample carryover contribution from at
least one other sample, an assay of the at least one other sample
preceding the individual assay of the given sample;
(b) calculating the sum of the sample-to-sample carryover contribution(s)
from the at least one other sample for at least one assay of the at least
one other sample that precedes the individual assay of the given
sample;
(c) comparing the sum calculated in step (b) to the sensitivity threshold of
the individual assay of the given sample; and
(d) if the sum calculated in step (b) is less than the sensitivity threshold of
the individual assay of the given sample, establishing an order for
execution of assays for the given sample that includes the individual
assay of the given sample;
(e) carrying out the individual assays in the order established in step (d);
but
(f) if the sum calculated in step (b) is greater than the sensitivity
threshold of the individual assay of the given sample, aspirating at
least one portion of the given sample from the original sample
container and dispensing that at least one portion into at least one
additional sample container, the at least one portion of the given
sample dispensed into the at least one additional sample container to
be used to carry out the individual assay of the given sample;
(g) carrying out the individual assays in the order established in step (f).

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Application 11/809,256

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The following grounds of rejection are before us for review:
I. Claims 1-3 stand rejected under 35 U.S.C. § 103(a) as being
rendered obvious by the combination of Givens,
2
Haeckel,
3
and
Matsubara.
4

II. Claims 4-6 stand rejected under 35 U.S.C. § 103(a) as being
rendered obvious by the combination of Givens, Haeckel, and
Matsubara as further combined with Burns.
5

We reverse.
ISSUE
Has the Examiner established by a preponderance of the evidence that
the combination of Givens, Haeckel, and Matsubara renders obvious the
method of independent claim 1?

FINDINGS OF FACT
FF1. The Examiner‟s statement of Rejection I may be found at pages 4-7 of
the Answer.
FF2. The Examiner finds that Givens teaches steps (a) through (e) of claim
1 for minimizing reagent-to-reagent carryover (Ans. 4-5).
FF3. Specifically, as to step (b), the Examiner finds that Givens teaches:

2
Givens et al., WO 98/45679, published October 15, 1998
3
R. Haeckel, International Union of Pure and Applied Chemistry –
Proposals for the Description and Measurement of Carry-Over Effects in
Clinical Chemistry, 63 PURE & APPL. CHEM. 301-306 (1991).
4
Matsubara et al., EP 0 977 039 A2, published February 2, 2000.
5
Burns et al., US 5,576,215, issued November 19, 1996.
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calculating a “total random access penalty (TRAP)” (p. 5, lines
16-17; p. 18, clm 15) for a given order of assays, which is
clearly a sum (e.g. p. 10, line 2; the given TRAP is 1.15, the
sum of three exemplary penalties 1.0, 0.1, and 0.05 given on p.
9, lines 21-23); the penalties taught by Givens are arbitrary
numerical values, but can include values based on the precision
of the assays involved (p. 5, line 4; p. 18, clm 10).

(Ans. 5.)
FF4. Specifically, Givens teaches:
[I]t is an object of the present invention to provide a method to
minimize the additional time and cuvettes necessary for probe
washing to prevent cross-contamination. More particularly, it
is an object of the present invention to sequence assays in an
optimal way to minimize wasted time and cuvette wells.
These and other objects are provided by a method, and an
apparatus for performing the method, which comprises:
providing at least one sample to be tested;
identifying a plurality of assays to be run on the
sample(s);
providing a knowledge base of cross-contamination
issues and their penalties;
utilizing the knowledge base to search the state space for
an optimal sequence for the plurality of assays; and
performing the plurality of said assays in the optimal
sequence.

(Givens, p. 3.)
FF5. The Examiner notes that “Givens does not teach calculating the
penalty based on sample-to-sample carryover, nor does Givens teach
splitting the sample into at least one additional container and performing
assays on the divided sample” (Ans. 5).
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FF6. The Examiner cites Haeckel for teaching “that carryover occurs both
as a sample-to-sample („specimen-to-specimen‟) carryover and reagent-to-
reagent carryover” (Ans. 5).
FF7. The Examiner finds that Haeckel teaches that carryover effects are
dependent on the concentration of the sample or reagent, and that “assays
have a „carryover-safe range‟ . . ., which constitutes a maximal sensitivity
threshold of the assay” (id.).
FF8. The Examiner concludes that it would have been obvious to the
ordinary artisan at the time of invention to use assay-sequence penalty
calculations based on sample-to-sample carryover as taught by Haeckel for
the assay-sequence reagent-to-reagent carryover as taught by Givens to
minimize sample-to-sample carryover (Ans. 6).
FF9. The Examiner finds that Matsubara teaches:
c. determining whether the sample-to-sample carryover
threshold of an assay will be exceeded for a sample for a
sequence of assays (0030: “an analysis item needs to avoid the
affection of very small carry-over between the samples [sic]”)
f. dividing a sample “from a single sample bottle to a plurality
of receiving containers” (0024), with the object of avoiding the
effects of “carry-over between samples" (0019; also 0020-0022)
g. performing the assays on the divided sample (0024)

(Id.)
FF10. Matsubara is drawn to a “handling method of a body fluid sample and
an analysis apparatus using the handling method which can sample the body
fluid samples using a plurality of pipetting devices” (Matsubara, ¶1).
FF11. Specifically, Matsubara teaches:
The present invention is characterized by an analysis
apparatus in which a sample is sampled from a single sample
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bottle to a plurality of receiving containers using a plurality of
sample pipetting devices, and the each sample received in each
of the receiving containers is analyzed, wherein the plurality of
sample pipetting devices include first pipetting devices using a
disposable nozzle tip and second pipetting devices using a
repetitive used pipette nozzle, and operation of sampling the
sample from the single sample bottle is executed by the second
pipetting devices after executed by the first pipetting devices.

(Id. at ¶24.)
FF12. Matsubara notes that in an apparatus that automatically analyzes fluid
samples, “many samples are successfully pipetted usually using one pipette
nozzle,” which may lead to “a contamination problem of the following
samples caused by residue of the preceding sample on the pipette nozzle”
(id. at ¶6).
FF13. Matsubara teaches that it is an object of the invention “to avoid the
carry-over between samples by using both of a pipetting device of a type
which samples a sample using a repetitively used pipette nozzle and a
pipetting device of a type which samples a sample using a disposable
nozzle” (id. at ¶21).
FF14. Matsubara teaches for immune or DNA analysis “whenever the
samples are changed, the nozzle tips are changed, and the analysis measured
value of the immune analysis item or the DNA analysis item is not affected
by the carry-over between samples” (id. at ¶¶27-28).
FF15. Matsubara teaches further that “the analysis measured value of the
biochemical analysis item does not receive the affection by the carry-over
between samples by washing the pipette nozzle repetitively used for
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sampling the sample relating to the biochemical analysis item by a well-
known washing method whenever the samples are changed” (id. at ¶29).
FF16. The Examiner concludes that it would have been further obvious to
the ordinary artisan to modify the assay ordering method taught by the
combination of Givens and Haeckel and divide the sample and assay
sequences if the sample-to-sample carryover would be exceeded given the
teachings of Matsubara (Ans. 7).

PRINCIPLES OF LAW
While the analysis under 35 U.S.C. § 103 allows flexibility in
determining whether a claimed invention would have been obvious, KSR
Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007), it still requires showing
that “there was an apparent reason to combine the known elements in the
fashion claimed by the patent at issue.” Id. “We must still be careful not to
allow hindsight reconstruction of references to reach the claimed invention
without any explanation as to how or why the references would be combined
to produce the claimed invention.” Innogenetics, N.V. v. Abbott Labs., 512
F.3d 1363, 1374 n.3 (Fed. Cir. 2008).

ANALYSIS
Appellants argue that the combination of Givens, Haeckel, and
Matsubara is “piecemeal reconstruction of the prior art, which is
impermissible” (Reply Br. 6). Specifically, as to Givens, Appellants argue
that the Examiner picked and chose only those parts of the reference that
supported the combination, “to the exclusion of other parts necessary to the
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full appreciation of what such reference fairly suggests to one of ordinary
skill in the art” (id.). As to Matsubara, Appellants assert that Matsubara
“merely discloses that more than one sample container can be used,” but
does not disclose anything that is relevant to the method of claim 1 (id. at 5).
We agree with Appellants that the Examiner has failed to set forth a
prima facie case of obviousness. Specifically, we agree with Appellants that
none of Givens, Haeckel, and Matsubara, either alone or in combination,
suggest the method of independent claim 1. Givens searches state space to
determine the best assay order to minimize reagent-to-reagent crossover
effects. Thus, even if the ordinary artisan were to combine Haeckel with
Givens to optimize assay order to minimize specimen-to-specimen cross-
over, the combination would suggest using state space search strategy taught
by Givens. There is nothing in the combination that teaches or suggests
steps (f) and (g) of claim 1.
Matsubara does not remedy that deficiency. Matsubara portions a
sample into a plurality of receiving containers for analysis (FF11).
Matsubara teaches that when one is worried about sample-to-sample
carryover, a new nozzle is used or the nozzle is washed (see FF14 and 15).
Thus, contrary to the findings of the Examiner, Matsubara does not teach or
suggest steps (f) and (g) of claim 1. We are thus compelled to reverse the
rejection.
As to the addition of Burns, the Examiner relies on Burns for teaching
a method of scheduling assays based on timing factors (Ans. 8). Thus,
Burns does not remedy the deficiencies set forth above with respect to the
combination of Givens, Haeckel, and Matsubara.
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CONCLUSION OF LAW
We conclude that the Examiner has not established by a
preponderance of the evidence that the combination of Givens, Haeckel, and
Matsubara renders obvious the method of independent claim 1. We thus
reverse the rejection of claims 1-3 under 35 U.S.C. § 103(a) as being
rendered obvious by the combination of Givens, Haeckel, and Matsubara.
As Burns does not remedy the deficiencies of that combination, we also
reverse the rejection of claims 4-6 under 35 U.S.C. § 103(a) as being
rendered obvious by the combination of Givens, Haeckel, and Matsubara as
further combined with Burns.

REVERSED

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