Ex Parte Kawate et al

Patent Trial and Appeal Board

Jul 28, 2015

11029279 (P.T.A.B. Jul. 28, 2015)

UNITED STATES PATENT AND TRADEMARK OFFICE
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
11/029,279 01/05/2005 Yasunori Kawate 11333/64 1981
757 7590 07/28/2015
BGL
P.O. BOX 10395
CHICAGO, IL 60610
EXAMINER
BROWN, MELANIE YU
ART UNIT PAPER NUMBER
1677
MAIL DATE DELIVERY MODE
07/28/2015 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 YASUNORI KAWATE, TERUYA MATSUMOTO, and
KAYOKO OTSUBO1
__________

Appeal 2012-011002
Application 11/029,279
Technology Center 1600
__________

Before DONALD E. ADAMS, ROBERT A. POLLOCK, and
JACQUELINE T. HARLOW, Administrative Patent Judges.

POLLOCK, Administrative Patent Judge.

DECISION ON APPEAL
Appellants appeal under 35 U.S.C. § 134(a) from the Final Rejection
of claims 1–12 and 23–32. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
Appellants’ invention relates to an apparatus “for detecting and
analyzing an analyte contained in a specimen such as blood or urine by
immunological aggregation reaction using carrier particles.” Spec. ¶ 2.

1 Appellants identify the Real Party in Interest as Sysmex Corporation. App.
Br. 2.
Appeal 2012-011002
Application 11/029,279

2
According to Appellants, “[t]he present invention uses internal information
and size information to count [aggregated and non-aggregated] carrier
particles discriminatorily from spurious particles,” such as erythrocytes,
platelets, and fat particles. App. Br. 4. “Internal information” may be
obtained from measurements of side scattered light intensity and provides an
indication of particle density. Id.; Spec. ¶ 39. “Size information” may be
obtained from measurements of forward scattered light and provides
information regarding the size and, therefore, aggregation state of particles.
App. Br. 4; Spec. ¶ 40.
Claims 1–12 and 23–32 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Nakashima2 and Nagai.3 Appellants
do not provide substantive arguments specific for claims 2–12 and 23–32.
See App. Br. 26. Accordingly, we focus on representative claim 1, which
reads as follows:
1. An immunoassay apparatus comprising:
(a) a sample preparing section configured to prepare a sample
by mixing a specimen with carrier particles on which an
antibody or an antigen is immobilized which reacts with an
analyte in the specimen;
(b) a detector configured to detect internal information and
size information on particles, including the carrier particles,
contained in the sample; and
(c) a central processing unit and a memory section storing
program steps executed by the central processing unit to:
(i) identify the carrier particles in the particles
contained in the sample by analyzing at least the
obtained internal information of the particles against
threshold information; and

2 Nakashima et al., US 2003/0082662 Al, published May 1, 2003.
3 Nagai, US 6,365,106 B1, issued Apr. 2, 2002.
Appeal 2012-011002
Application 11/029,279

3
(ii) calculate a degree of aggregation of the identified
carrier particles, using the obtained size information,
based on which aggregated carrier particles and non-
aggregated carrier particles are distinguishable in the
identified carrier particles.

FACTUAL FINDINGS
FF1. The Examiner finds that Nakashima teaches an immunoassay
apparatus comprising “a detector for detecting internal information and
size information from particles contained in [a] sample (side and forward
light scattering detected . . . )” and “a central processing unit . . . for
identifying the carrier particles . . . and for calculating a degree of
aggregation of the carrier particles” from the scattered light. Ans. 5; see
also id. at 7 (“Nakashima et al. teach identification and detecting a degree
of aggregation based on forward and side scattered light.”).
FF2. Nakashima discloses that “[f]or the detection of the scattered light
from the agglutination reaction mixture including agglutinated particles
and unagglutinated particles, the reaction mixture is first diluted to adjust
the concentration of the particles . . . so that the particles pass through the
center of the flow cell one by one in line . . . [and] are irradiated with a
laser beam.” Nakashima ¶ 60. “The scattered light detected may be
forward scattered light, side scattered light or both of them.” Id.
(emphasis added).
FF3. Nakashima further discloses that “[t]he unagglutinated particles,
agglutinated particles and blood cells have different intensities of forward
scattered light because of their different particle sizes, and therefore, they
can be distinguished[ ]from each other. Id. ¶ 62. “The particles suitably
have such a size that allows the particles to be distinguished from blood
Appeal 2012-011002
Application 11/029,279

4
cells, especially, erythrocytes. Since the size of erythrocytes is about 7 to
8 μm in average particle diameter in plan view and about 2.2 μm in
thickness, the insoluble carrier particles suitably have a diameter of about
0.1 to 1.0 μm.” Id. ¶ 41; see id. Fig. 3.
FF4. The Examiner finds that although Nakashima “identifies particles on
the basis of the side scattered light and forward scattered light” (Ans. 6;
see id. at 7), it “differ[s] from the instant claims by not specifically
teaching the central processing unit identifying the carrier particles on the
basis of the obtained internal information (side scattered light)” (id. at 5;
see id. at 6).
FF5. The Examiner finds that “Nagai teaches a central processing unit and
memory storage for analyzing both forward scattered light and side
scattered light from a sample” (Ans. 9) and, thus, relies on Nagai for
teaching “the central processing unit and a memory section storing the
appropriate program steps” (id. at 12). According to the Examiner, “the
central processing unit, memory storage, and analysis steps taught by
Nagai are commonly known prior art analysis methods for analyzing
forward and side scattered light, and can be applied to the central
processing unit in the apparatus of Nakashima.” Id. at 9.
FF6. Nagai discloses a blood analyzer suitable for analyzing blood
components including leukocytes, erythrocytes, and platelets. Nagai
Abstract, Title; 6:60–67. Nagai teaches the differentiation of blood
components using forward and side scattered light. Id. 9:40–47, see id.
Figs 9–12.
FF7. The Examiner concludes that it would have been obvious “to use as
the processing steps in the apparatus of Nakashima et al., a central
processing unit that identifies sample components on the basis of
Appeal 2012-011002
Application 11/029,279

5
obtained internal information and calculates the size of the sample
components on the basis of size information as taught by Nagai, in order
to accurately detect and differentiate between particles in a sample.”
Ans. 7. “[O]ne having ordinary skill in the art would have a reasonable
expectation of success in using a central processing unit to analyze
forward and side scattered light as taught by Nagai to identify particles
and calculate a degree of aggregation” (id.) because “both references are
drawn to processing forward and side scattered light” (id. at 8, 12). In
particular, Nakashima “teach[es] identification and detecting a degree of
aggregation based on forward and side scattered light” (id. at 7) and,
though “Nakashima is not specific to how processing occurs when
measurement of both forward and side scattered light is performed” (id.
at 10), “Nagai provides guidance as to how the particles are identified
and aggregation is calculated using forward and side scattered light” (id.
at 5, 7).
ANALYSIS
Appellants contend that the Examiner errs in failing to provide
“reasons as to why one of ordinary skill in the art having knowledge of
Nakashima would have had to look out for prior art, such as Nagai” (Reply
Br. 3). In particular, Appellants argue that “Nakashima teaches against
being combined with Nagai” (App. Br. 26) because “[b]y carefully choosing
the carrier particles having sizes smaller than spurious blood particles,
Nakashima dispenses with the screening process using the side scattered
light such as recited in claim 1” (Reply Br. 3; see App. Br. 20–22, 26).
“Therefore, there is no need at all in Nakashima to perform carrier particles
screening processing using the internal [side scatter] information. Analysis
of only the size information suffices to discriminate the carrier particles from
Appeal 2012-011002
Application 11/029,279

6
the blood cells in the size distribution histogram.” App. Br. 24. Appellants
further assert that “[t]here is nothing in Nakashima that discloses or teaches
using the side scattered light information for identification of the carrier
particles,” arguing that the statement at paragraph 60 of Nakashima that
“[t]he scattered light detected may be forward scattered light, side scattered
light or both of them,” merely refers to a detector “capable of detecting side
scattered light.” App. Br. 24; see FF 2.
We do not find Appellants arguments persuasive. “The combination
of familiar elements according to known methods is likely to be obvious
when it does no more than yield predictable results.” KSR Int’l Co. v.
Teleflex Inc., 550 U.S. 398, 416 (2007). “[T]he [obviousness] analysis need
not seek out precise teachings directed to the specific subject matter of the
challenged claim, for a court can take account of the inferences and creative
steps that a person of ordinary skill in the art would employ.” Id. at 418. “If
a person of ordinary skill can implement a predictable variation, § 103 likely
bars its patentability.” Id. at 417. In determining obviousness, “the test is
what the combined teachings of the references would have suggested to
those of ordinary skill in the art.” In re Keller, 642 F.2d 413, 425 (CCPA
1981).
In order to establish a prima facie case of obviousness, the Examiner
must show that each and every limitation of the claim is described or
suggested by the combination of prior art references or would have been
obvious based on the knowledge of those of ordinary skill in the art. In re
Fine, 837 F.2d 1071, 1074 (Fed. Cir. 1988). The Examiner can satisfy this
burden by showing “‘some articulated reasoning with some rational
underpinning to support the legal conclusion of obviousness.”’ KSR Int'l
Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) (quoting Kahn, 441 F.3d at
Appeal 2012-011002
Application 11/029,279

7
988). In the present case, we do not disturb the Examiner’s finding that
paragraphs 60 and 62 of Nakashima “teach that both forward scattered light
and side scattered light may be detected, but do not provide any teaching
regarding how analysis is performed with both forward and side scattered
light data.” Ans. 8. We further agree with the Examiner that one of
ordinary skill in the art would look to Nagai for guidance on the detection
and identification of particles using both forward and side scattered light “in
order to accurately detect and differentiate between particles in a sample.”
Id. at 7; see FF 7.
For the reasons set forth above, and as set forth in the Examiner’s
Answer, we affirm.
SUMMARY
We affirm the rejection of claim 1 under § 35 U.S.C. 103(a) as
unpatentable over the combination of Nakashima and Nagai. Claims 2–12
and 23–32 fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii).

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. § 1.136(a).

AFFIRMED
sl