Ex Parte Nagai et al

Patent Trial and Appeal Board

Mar 30, 2016

12408149 (P.T.A.B. Mar. 30, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/408,149
757 7590
BGL
P.O. BOX 10395
CHICAGO, IL 60610
0312012009
03/30/2016
FIRST NAMED INVENTOR
Takaaki Nagai
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
11333/272 8697
EXAMINER
NEGIN, RUSSELL SCOTT
ART UNIT PAPER NUMBER
1631
MAILDATE DELIVERY MODE
03/30/2016 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 TAKAAKI NAGAI, YUTAKA IKEDA,
and NORIYUKI NARISADA
Appeal 2013-003628
Application 12/408,149
Technology Center 1600
Before ERIC B. GRIMES, ULRIKE W. JENKS, and ROBERT A. POLLOCK,
Administrative Patent Judges.
PERCURIAM
DECISION ON APPEAL
This is a decision on appeal1under35 U.S.C. § 134 from the Examiner's
rejection of claims 1, 5, 6, 8-12, 15-17, 19, 21, and22. We have jurisdiction
under 35 U.S.C. § 6(b).
We affirm-in-part.
STATEMENT OF THE CASE
The Specification discloses "a biological sample analyzer and
computer program product for analyzing biological samples such as blood"
(Spec. 1, ,-i 2). The Specification also discloses that "the blood cells
1 Appellants identify the Real Party in Interest as Sysmex Corporation (App. Br. 2).
Appeal2013-003628
Application 12/408,149
contained in child blood have lower stainability than blood cell[ s] contained
in adult blood" (id. at 10, iJ 47). Thus, the values obtained for a given type
of blood cell from a sample of child blood will differ from the same type of
cell from a sample of adult blood, and the sampling values must be shifted in
order to improve the accuracy of the blood cell classification process (id. at
11, iii! 48--49).
Claims 1 and 10 are representative of the claims on appeal and read as
follows (emphasis added):
1. A blood sample analyzer, comprising:
a characteristic information obtainer for obtaining characteristic
information representing a characteristic of a blood cell contained in a blood
sample of a patient, wherein the characteristic obtainer comprises a sample
preparing section for preparing a measurement sample from the blood
sample and a staining solution, and a light detecting section for irradiating
the measurement sample with light and detecting at least fluorescent light
emitted from blood cells contained in the measurement sample;
a processor; and
a memory storing software instructions adapted to enable the
processor to perform operations comprising:
(a) determining whether the patient is an adult or a child;
(b) analyzing, when the patient is determined to be an adult, the
characteristic information based on a first condition for analyzing a blood
sample of the adult, wherein the analyzing in operation (b) comprises:
generatingfirst classification data suited for classifying blood cells in
the blood sample of the adult from the characteristic information obtained by
the characteristics information obtainer; and
classifying the blood cells in the blood sample into a plurality of types
based on a predetermined classification condition and the first classification
data; and
( c) analyzing, when the patient is determined to be a child, the
characteristic information based on a second condition for analyzing a blood
sample of the child, wherein the analyzing in operation ( c) comprises:
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Application 12/408,149
generating second classification data suited for classifying the blood
cells in the blood sample of the child from the characteristic information
obtained by the characteristics information obtainer; and
classifying the blood cells in the blood sample into a plurality of types
based on the predetermined classification condition and the second
classification data.
10. A blood sample analyzer, comprising:
a characteristic information obtainer which obtains characteristic
information representing a characteristic of a blood cell contained in a blood
sample of a patient based on a first obtaining condition suited for a blood
sample of an adult, and obtains characteristic information representing the
characteristic of the blood cell contained in the blood sample of the patient
based on a second obtaining condition suited for a blood sample of a child;
and
a processing section for executing an operation to analyze the
characteristic information obtained by the characteristic information
obtainer,
wherein the characteristic information obtainer comprises:
a sample preparing section for preparing a measurement sample
from the blood sample and a staining solution;
a fluorescent iight detecting section for irradiating the
measurement sample with light and detecting fluorescent light emitted from
the measurement sample; and
a controller for determining whether the patient is an adult or a
child, and for controlling the fluorescent light detecting section so as to
detect the fluorescent light at a detection sensitivity suited for a blood
sample of an adult when the patient has been determined to be an adult, and
detect the fluorescent light at a detection sensitivity suited for a blood
sample of a child when the patient has been determined to be a child.
The other independent claims are claims 17, 19, and 22. Claim 17 is
similar to claim 1 but is directed to a computer program product for carrying
out the analysis recited in claim 1. Claims 19 and 22, like claim 10, require
controlling the detection sensitivity of a fluorescent light detector based on
whether the sample is from an adult or a child.
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Application 12/408,149
Issue
The Examiner has rejected claims 1, 5, 6, 8, 10-12, 15-17, 19, 21, and
22 under 35 U.S.C. § 103(a) as obvious in view of Oosterwijk,2 Ravkin,3
Torre-Bueno,4 and Osugi5 (Ans. 3-7). The Examiner has also rejected claim
9 under 35 U.S.C. § 103(a) as obvious in view of Oosterwijk, Ravkin, Torre-
Bueno, Osugi, and Herzenberg6 (Ans. 7-8). Appellants have waived
arguments directed to claim 9, so we will consider these rejections together.
The issues presented are: Has the Examiner established by a
preponderance of the evidence that Oosterwijk, Ravkin, Torre-Bueno, and
Osugi would have made obvious
(i) a blood analyzer that comprises a memory comprising
instructions to determine whether a patient is a child or an adult, and to
classify blood cells into plural types based on either first or second
classification data for adult or child blood samples, respectively, as recited in
claim 1 ; or
2 Oosterwijk et al., Strategies for Rare-Event Detection: An Approach for
Automated Fetal Cell Detection in Maternal Blood, 63 American Journal of
Human Genetics 1783-1792 (1998).
3 Ravkin et al., Automated Microscopy System for Detection and Genetic
Characterization of Fetal Nucleated Red Blood Cells on Slides, 3260 SPIE
180-191 (1998).
4 Torre-Bueno, US 2004/0009098 Al, January 15, 2004.
5 Osugi et al., Age-related Changes in Surface Antigens on Peripheral
Lymphocytes of Healthy Children, 100 Clinical and Experimental
Immunology 543-548 (1995).
6 Herzenberg et al., Fetal cells in the blood of pregnant women: Detection
and enrichment by fluorescence-activated cell sorting, 76 Proc. Natl. Acad.
Sci. USA 1453-1455 (1979).
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Application 12/408,149
(ii) a blood analyzer comprising a controller for controlling
fluorescent light detection sensitivity based on whether the patient is an adult
or a child, as recited in claim 1 O?
Findings of Fact
1. The Examiner finds that Oosterwijk discloses "an automated
microscopy and image analysis system comprising a computer, a memory
with instructions (algorithm) and [a] microscope (an information obtainer)"
(Ans. 3 (citing Oosterwijk 1785, col. 1 )). "[T]he algorithm executes steps in
which the characteristic information or image is analyzed based on a first
condition and second condition; i.e. the absence or presence of fetal
hemoglobin" (id. at 3 (citing Oosterwijk 1785, col. 1 )). "Oosterwijk et al.
teaches differentiating (classifying) between maternal and fetal cells based
on markers in the blood" (id. at 4 (citing Oosterwijk 1784, col. 1 )).
2. Oosterwijk discloses "the use of automated microscopy and
image analysis to detect the presence of rare fetal nucleated red blood cells
(NRBCs) circulating in maternal blood ... by immunocytochemical staining
for fetal hemoglobin (HbF)" (Oosterwijk 1783, Abstract).
3. Oosterwijk discloses that "[s]taining for HbF was performed
... by a Cadenza automated immunostainer" (Oosterwijk 1785).
4. The Examiner finds that "Ravkin ... illustrates recognition of
(i.e. classifying) fetal blood cells into a plurality of types based on the
predetermined classification conditions" (id. (citing Ravkin 184, Fig. 4)).
5. Ravkin discloses that the "Applied Imaging has developed ... a
system for semiautomatic detection of fetal nucleated red blood cells"
(Ravkin 180, Abstract).
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Application 12/408,149
6. The Examiner finds that Oosterwijk and Ravkin "do not teach
determining whether the patient is an adult or a child" (Ans. 5).
7. The Examiner finds that Torre-Bueno discloses "an automated
microscopy system with an auto-staining function ... [which] identifies a
staining characteristic of the biological sample and dispenses a reagent on to
the region to be stained based upon the staining characteristic" (Ans. 5
(citing Torre Bueno iJ 7)). "Torre-Bueno shows [a] sample preparation
section ... [and] a fluorescent light section" (id. (citing Torre-Bueno, Fig.
2)). "Torre-Bueno suggests [that] the system can identify rare cells ... [and]
shows [that] different cells can be stained with distinct stains" (id. (citing
Torre-Bueno iJ 90)). "[T]he system includes a controller that determines
which patient the sample is from and makes a determination how the sample
should be treated/stained, which parameters to measure and how to measure
those parameters by looking up the information in pre-created database" (id.
(citing Torre-Bueno iii! 43, 97, and 122)).
8. Torre-Bueno discloses a "method for automated staining of a
biological sample on a substrate" (Torre-Bueno, iJ 7). "[T]he method further
comprises identifying a staining characteristic of the biological sample and
dispensing the reagent on to the region to be stained based upon the staining
characteristic" (id.).
9. Torre-Bueno discloses that a "camera can be used to read a bar
code, or other identifier, on a slide or slide rack ... [to] identify what stain
should be used on the slide, or it could be a unique code used to look up the
desired stain in a pre-created database" (Torre-Bueno, iJ 43).
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Application 12/408,149
10. Torre-Bueno discloses an apparatus for "the automatic scanning
of prepared microscope slides for the detection of candidate objects of
interest such as normal and abnormal cells, e.g., tumor cells" (Torre-Bueno,
ii 90).
11. Torre-Bueno discloses that the imaging apparatus detects "the
fluorescence or luminescence of the molecule when exposed to a wavelength
that excites a fluorescent indicator attached to the fluorescent agent or
exposed to conditions that allow for luminescence" (Torre-Bueno, ii 97).
12. The Examiner finds that Oosterwijk, Ravkin, and Torre-Bueno
"do not teach determining whether the patient i[ s] an adult or a child" (Ans.
6).
13. The Examiner finds that Osugi discloses that "human blood
undergoes age related changes ... [and discloses] that the surface antigens
on peripheral lymphocytes in children change as they mature" (Ans. 6
(citing Osugi, Abstract)).
14. Osugi states that "age-related changes in proportion of various
subsets within lymphocytes were investigated in cord blood and peripheral
blood from healthy children and adults" (Osugi 543, Abstract).
15. Osugi states that there are "significant age-related changes in
the proportions of CD45RA + and CD45Ro+ T cells, S6F 1 +cng+ T cells, yo
T cells, CDS+ B cells and NK cells" (Osugi 547). "When evaluating the
immune status of children, consideration of age-related changes is essential"
(id.).
16. The Examiner concludes that it would have been obvious to one
of ordinary skill in the art to:
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Application 12/408,149
(i) modify Oosterwijk's system "with the distribution and
classification plot of Ravkin et al. for classifying cells because Ravkin et al.
shows the plot aids the review, classification, and analysis processes" (Ans.
6 (citing Ravkin, Fig. 4));
(ii) modify the system of Oosterwijk and Ravkin "with the auto-
stainer of Torre-Bueno because Torre-Bueno shows auto-stainers provide
the advantages of introducing cost savings, uniform slide preparation, and
reduction in errors" (id. (citing Torre-Bueno, iJ 6)), and
(iii) modify the system of Oosterwijk, Ravkin, and Torre-Bueno by
distinguishing blood samples of "adults versus children as suggested by
Osugi ... [because] "differentiating adult versus child blood samples ...
leads to an understanding of how the immune system changes in a body as a
function of age" (id. at 6-7 (citing Osugi, 543) ).
Analysis
With regard to claims 1 and 17, we agree with the findings and
conclusions set out in the Final Rejection and in the Answer. We address
below Appellants' arguments regarding these claims.
Appellants argue that the cited references "fail to disclose the claimed
determination of an adult/child patient and its effect on the claimed blood
analysis" (Appeal Br. 6). Appellants argue that claims 1 and 17 recite using
the determination of whether the patient is an adult or a child "for generating
different classification data suited for classifying blood cells in the blood
sample," but these "elements are not addressed by the Final Office Action or
the Advisory Action" (id. at 7). Appellants argue that although Osugi
discloses that "certain cells changed with age ... [this] is not a disclosure of
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Application 12/408,149
the claimed adult/child determination and resulting classification data
generation .... [T]he claims recite a different analysis of characteristic
information depending on whether the sample is from an adult or a child"
(id. at 8).
Appellants' arguments are not persuasive. Claims 1 and 1 7 require
instructions that allow a processor to determine whether a patient is a child
or adult. No specific criteria for the determination are recited, and therefore
this step encompasses, for example, determining that the patient is a child or
adult based on an input (such as a bar code) that indicates the age of the
patient.
Osugi discloses a study of lymphocytes in children and adults (FF 14 ).
Osugi discloses that, due to age-related changes in the proportions of
lymphocyte subsets, age must be taken into consideration in evaluating the
immune status of patients (FF 15). In view of this disclosure in Osugi, we
agree with the Examiner that it would have been obvious to one of ordinary
skill in the art to configure a blood sample analyzer suggested by the
combination of Oosterwijk, Rav kin, and Torre-Bueno to comprise a memory
and processor adapted to determine whether a patient is an adult or a child
(based, e.g., on age) and then generate classification data based on whether
the patient is an adult or child, and classify cells in patient sample according
to the generated classification data. Such a blood sample analyzer would
allow for the accurate analysis of immune status of adult and child patients.
Appellants also argue, in response to the Answer, that "[t]he
first/second classification data is based on the adult/child determination and
therefore 'classifying the blood cells in the blood sample into a plurality of
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Application 12/408,149
types based on a predetermined classification condition and the [first or
second] classification data' is clearly a connection between the classification
and the determination" (Reply Br. 3).
We agree with the Examiner (Ans. 10), however, that claims 1 and 17
do not require using the adult/child determination in classifying the types of
blood cells in the sample being analyzed. The claim language, in fact, does
not even require the "first classification data" and "second classification
data" to be different; thus, the same classification data could be used to
classify cells in a sample regardless of whether it was from an adult or a
child.
Thus, we affirm the rejection of independent claims 1 and 1 7 as being
obvious in view of Oosterwijk, Ravkin, Torre-Bueno, and Osugi. Claims 5,
6, and 8 have not been argued separately from claim 1 and therefore fall with
that claim. See 37 C.F.R. § 41.37(c)(l)(iv).
We also affirm the rejection of claim 9 based on Oosterwijk, Ravkin,
Torre-Bueno, Osugi, and Herzenberg because, as noted above, Appellants
have waived arguments directed to claim 9.
With regard to claims 10, 19, and 22, however, we agree with
Appellants that the Examiner has not shown that the cited references
disclose "changing the detection sensitivity based on an adult/child
determination" (Appeal Br. 9). 7 Appellants argue that a "barcode affixed to
the slides in Torre-Bueno ... is not a disclosure of controlling detection
7 Appellants also apply this argument to claim 17 (Appeal Br. 9), but claim
17 does not include the relevant limitation.
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Application 12/408,149
sensitivity based on whether a sample is from a child or an adult as claimed"
(id.).
The Examiner responds that "Torre-Bueno teaches a fluorescence
detector (cover figure) that detects a wide range of cells. Absent a limiting
teaching with regard to fluorescent ranges that exclude child vs. adult cells,
it is interpreted that the broad range of cells ... detected includes
fluorescence emitted from both child and adult cells" (Ans. 9).
We do not agree with the Examiner's reasoning. The fact that Torre-
Bueno' s system could be used with both adult and child cell types and blood
samples is not persuasive because the claims specifically require software or
a controller to control detection sensitivity based on whether the patient is an
adult or a child.
Thus, we reverse the rejection of independent claims 10, 19, and 22,
and dependent claims 11, 12, 15, 16, and 21 as being obvious in view of
Oosterwijk, Ravkin, Torre-Bueno, and Osugi.
Conclusion of Law
A preponderance of the evidence supports the Examiner's conclusion
that Oosterwijk, Ravkin, Torre-Bueno, and Osugi would have made obvious
a blood analyzer that comprises a memory comprising instructions to
determine whether a patient is a child or an adult, and to classify blood cells
into plural types based on either first or second classification data for adult
or child blood samples, respectively, as recited in claim 1.
However, the Examiner has not adequately explained how the
combination of the cited references would have made obvious a blood
analyzer comprising a controller for controlling fluorescent light detection
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Application 12/408,149
sensitivity based on whether the patient is an adult or a child, as recited in
claim 10.
SUMMARY
We affirm the rejection of claims 1, 5, 6, 8, 9, and 17 under 35 U.S.C.
§ 103(a). We reverse the rejection of claims 10-12, 15, 16, 19, 21, and 22
under 35 U.S.C. § 103(a).
Claims 1, 5, 6, 8, 10-12, 15-17, and 19 have also been provisionally
rejected on the ground of nonstatutory obviousness-type double patenting as
being unpatentable over (i) claims 1-20 of copending Application No.
12/408,127 (Ans. 8) and (ii) claims 1-3, 6-10, 12, and 19 of copending
Application No. 12/408,181 (Ans. 8-9). Appellants do not argue these
rejections, so we affirm them.
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. § l.136(a).
AFFIRMED-IN-PART
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