Ex Parte Diby et al

Patent Trial and Appeal Board

Feb 9, 2015

12874324 (P.T.A.B. Feb. 9, 2015)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte KOUAKOU DIBY, LAWRENCE BAKER, JUDITH BANTA,
JAMES FREEMAN, and PAULA MALLON

Appeal 2013-004384
Application 12/874,324
Technology Center 1700
____________

Before BRADLEY R. GARRIS, CHUNG K. PAK, and
N. WHITNEY WILSON, Administrative Patent Judges.

WILSON, Administrative Patent Judge.

DECISION ON APPEAL
Appellants1 appeal under 35 U.S.C. § 134 from the April 17, 2012
decision of the Primary Examiner finally rejecting claims 7–10, 12, and 16–
18. We have jurisdiction over the appeal under 35 U.S.C. § 6(b).
We affirm.

1 Appellants identify the Real Party in Interest as Siemens Healthcare
Diagnostics Inc. (Appeal Br. 3).
Appeal 2013-004384
Application 12/874,324

2
CLAIMED SUBJECT MATTER
Appellants’ invention is directed to a method for testing a sample of
biological organism material. Claim 7 is representative of the claims on
appeal and is reproduced below from the Claims Appendix to the Brief:
7. A method for testing a sample of biological organism material
comprising:
(a) testing a first control sample having known properties and
characteristics with testing means to analyze the known properties
and characteristics of said first control sample to obtain first
control test results;
(b) comparing the first control test results with the known
properties and characteristics of the first control sample to confirm
the accuracy of the testing means;
(c) after confirming the accuracy of the testing means on the first
control sample, testing a sample of biological organism material with
the testing means to analyze its properties and characteristics of the
biological organism material and to obtain test results, and storing the
test results while refraining from a disclosure of the test results;
(d) after storing the test results, testing a second control sample
having known properties and characteristics with the testing means
to analyze the properties and characteristics of the second control
sample to obtain second control test results;
(e) comparing the second control test results with the known
properties and characteristics of the second control sample to again
confirm the accuracy of the testing means;
(f) after confirming the accuracy of the testing means on the
second control sample, disclosing the test results of the sample of
biological organism material, wherein the control test results for each
control sample are characterized by an index representing a
numerical value, and wherein an unacceptable index is represented
by a numerical value that is outside a range of acceptable indices; and
(g) automatically discarding the test results for the organism
sample and initiating new testing of first and second control
samples to bracket a new test of the organism sample of biological
material when an unacceptable index occurs for the control sample
that is tested immediately following the test results of the sample
of organism biological material.
Appeal 2013-004384
Application 12/874,324

3
REJECTIONS
(1) Claims 7–9, 12, and 16–18 are rejected under 35 U.S.C. § 103(a)
as being unpatentable over Wardlaw2 in view of Clark.3
(2) Claim 10 is rejected under 35 U.S.C. § 103(a) as being
unpatentable over Wardlaw in view of Clark, and further in view of
Christen.4
Appellants do not separately argue the patentability of claims 8, 9, 12,
and 16–18 (Appeal Br. 13), nor do they make separate arguments in favor of
the patentability of claim 10 (Appeal Br. 14). Accordingly, our discussion
will focus on the rejection of independent claim 7 as being unpatentable over
Wardlaw and Clark.

DISCUSSION
The Examiner finds that Wardlaw discloses a method and apparatus
for providing quality control in an instrument for medical analysis (Ans. 3).
The Examiner further finds that Wardlaw discloses each of the steps recited
in claim 7, including that Wardlaw teaches the use of control samples for
determining the operability of its system, except that Wardlaw does not
disclose using them in a “bracketing” fashion, immediately before and after
testing the patient sample (Ans. 4). The Examiner also finds that Clark
discloses an automated blood analysis system which is calibrated
immediately before and after the testing of blood samples, so that the blood

2 Wardlaw et al., U.S. Patent Application Pub. 2002/0133255 A1, published
September 19, 2002.
3 Clark et al., U.S. Patent No. 4,109,505, issued August 29, 1978.
4 Christen et al., U.S. Patent No. 3,954,012, issued May 4, 1976.
Appeal 2013-004384
Application 12/874,324

4
tests results may be discarded if the before and after calibration readings
differ (id.).
The Examiner concludes that it would have been obvious to modify
Wardlaw’s method to perform the testing of the control samples in a
bracketing fashion as disclosed by Clark, in order to “provid[e] more
frequent quality control of the immunoassays system and verifying the
quality of the test performed on the patient samples” (id.).
Appellants make five principal arguments urging us to find error in
the rejection: (1) Wardlaw does not disclose automatically discarding test
results for an organism sample (Appeal Br. 7); (2) Clark uses bracketed
calibration tests, which are different from the control tests used by Wardlaw
and does not include automated retesting if calibration tests differ; therefore
combining Clark’s teachings with those of Wardlaw would not yield the
claimed method (Appeal Br. 8–9); (3) the references do not teach the use of
an index representing a numerical value to determine whether the testing
means is accurate (Appeal Br. 9–11); (4) the Examiner has not provided a
reason why Clark makes the claimed invention obvious (Appeal Br. 11), and
(5) the Examiner has not shown that the references teach or suggest
initiating new testing of first and second control samples to bracket a new
test (Appeal Br. 11–12).
We have carefully reviewed all of the arguments and evidence of
record as set forth in the Appeal Brief, the Answer, and the Reply Brief, and
determine that Appellants have not demonstrated reversible error in the
rejection.
With regards to Argument (1) – that Wardlaw does not disclose
automatically discarding test results for an organism sample – the Examiner
Appeal 2013-004384
Application 12/874,324

5
correctly finds that Wardlaw explicitly teaches that its instrument can be
programmed not to release test results (which is functionally equivalent to
discarding them) if the control tests show that the machine is in a partially or
completely inoperable mode (Ans. 5–6; Wardlaw ¶ 24).
With regards to Argument (2) – that Wardlaw relates to operability (or
control), while Clark relates to calibration – the Examiner finds that both
performance testing (i.e., the control testing recited in the claims and the
operability testing disclosed by Wardlaw) and calibration testing (disclosed
by Clark) were conventional operations in automated assays (Ans. 6). The
Examiner also finds that using the timing of Clark’s calibration tests (which
bracket the blood analysis) to bracket the control tests of Wardlaw would
have been obvious because each reference uses its testing to determine
whether to keep or discard the analysis results (Ans. 6). Appellants have not
persuasively refuted this finding.
With respect to Argument (3) – that the references do not teach the
use of an index representing a numerical value to determine whether the
testing means is accurate –the Examiner finds that Appellants’ Specification
provides only a very general description of the index as a number that is
assigned to the test results (id., Spec. ¶¶ 10, 11), and that the use of an index
to describe test results is very conventional for any automated system (id.).
Appellants argue that “neither of the conventional automated systems of
Wardlaw and Clark bothers to disclose” the use of an index, as set forth in
the claims, but do not assert that the Examiner’s finding that use of an index
in this matter is conventional for automated systems is incorrect (Reply Br.
6). Therefore, Appellants have not provided persuasive evidence to show
error in the Examiner’s findings regarding the use of an index.
Appeal 2013-004384
Application 12/874,324

6
Regarding Argument (4) – that the Examiner has not provided a
reason why Clark makes the claimed invention obvious – the Examiner has
explicitly provided a reason why a person of skill in the art would have
combined the teachings of Clark and Wardlaw, and why combining Clark’s
bracketing of calibration/control tests into Wardlaw’s method would yield
the claimed invention (see Ans. 4).
Finally, with respect to Argument (5) – that the Examiner has not
shown that the references teach or suggest automatically initiating new
testing of first and second control samples to bracket a new test – we agree
with the Examiner (Ans. 5–6) that Wardlaw ¶ 245 fairly suggests initiating a
new test following a finding that the control sample shows that the analytical
instrument is inoperable. In response, Appellants merely assert that this
limitation is not shown by the art:
[T]he cited references do not disclose “automatically discarding
the test results for the organism sample and initiating new
testing of first and second control samples to bracket a new test
of the organism sample of biological material when an
unacceptable index occurs for the control sample that is tested
immediately following the test results of the sample of
organism biological material (emphasis added),” as well as
other claimed features and combination thereof.

(Reply Br. 5, emphasis in original.) Such a bare assertion, without
additional explanation, is not sufficient to rebut the Examiner’s findings.
37 C.F.R. § 41.37(c)(1)(iv) (“The arguments shall explain why the examiner
erred as to each ground of rejection contested by appellant”).

5 The Examiner does not explicitly refer to ¶ 24, but quotes language from
that paragraph.
Appeal 2013-004384
Application 12/874,324

7
In view of the arguments and evidence of record, we determine that
Appellants have not shown reversible error in the rejections.
CONCLUSION
We AFFIRM the rejection of claims 7–9, 12, and 16–18 under
35 U.S.C. § 103(a) as being unpatentable over Wardlaw in view of Clark.
We AFFIRM the rejection of claim 10 under 35 U.S.C. § 103(a) as
being unpatentable over Wardlaw in view of Clark, and further in view of
Christen.

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See
37 C.F.R. § 1.136(a) (1) (iv).

AFFIRMED

cdc