Ex Parte Tohma

Patent Trial and Appeal Board

Dec 8, 2016

10703935 (P.T.A.B. Dec. 8, 2016)

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.
10/703,935 11/07/2003 Ryuichi Tohma 11333/30 3115
757 7590 12/08/2016
BGL
P.O. BOX 10395
CHICAGO, IL 60610
EXAMINER
RAJ, RAJIV J
ART UNIT PAPER NUMBER
3626
MAIL DATE DELIVERY MODE
12/08/2016 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 RYUICHI TOHMA
____________________

Appeal 2014-0038741
Application 10/703,9352
Technology Center 3600
____________________

Before JOSEPH A. FISCHETTI, PHILIP J. HOFFMANN, and
MATTHEW S. MEYERS, Administrative Patent Judges.

MEYERS, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Appellant appeals under 35 U.S.C. § 134(a) from the Examiner’s final
rejection of claims 52–81. We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

1 Our decision references Appellant’s Appeal Brief (“Appeal Br.,” filed
October 11, 2013) and Reply Brief (“Reply Br.,” filed January 21, 2014), the
Examiner’s Answer (“Ans.,” mailed November 20, 2013), and Final Office
Action (“Final Act.,” mailed September 12, 2012).
2 Appellant identifies Sysmex Corporation as the real party in interest
(Appeal Br. 2).
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CLAIMED INVENTION
Appellant’s claimed invention relates generally “to clinical laboratory
systems connecting computers and analyzers through a network for
managing examination information relating to clinical examinations”
(Spec. 2, ll. 6–9).
Claims 52, 62, and 72 are the independent claims on appeal.
Claim 52, reproduced below with added bracketed notations, is illustrative
of the subject matter on appeal:
52. A non-transitory storage medium that stores
programs executable by at least one computer of a plurality of
computers forming a clinical laboratory system to:
[a] create, in a database, an entry which comprises an
identification of a patient, a type of analysis requested on a
sample from the patient and an identification of analyzer capable
of performing the requested type of analysis;
[b] each time a workflow for analyzing the sample
advances to respective workflow points, which comprise at least
some of (i) a point at which the sample is received, (ii) a point at
which the sample is arrived, (iii) a point at which the required
type of analysis is completed on the sample, (iv) a point at which
a result of the analysis is verified, and (v) a point at which a report
is sent regarding the result of the analysis, update the entry by
adding to the entry a time stamp indicating a chronology of
progress to a respective point;
[c] select entries in the database which meet at least one of
a first set of screening conditions, which comprise (a) a condition
for selecting all entries in the database, (b) a condition for
selecting an entry in which a particular type of sample is
analyzed and (c) a condition for selecting an entry in which a
particular analyzer is used;
[d] extract entries from among the selected entries which
meet at least one of a second sets of screening conditions
comprising time conditions each for extracting an entry that does
not advance to one of the workflow points within a
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predetermined time expected to take to advance to the one
workflow point; and
[e] prepare a notice for display for notifying the extracted
entries, at least some of which are each marked with an elapsed
time measured from the time stamp of one of preceding
workflow points.

REJECTIONS
Claims 52–57, 61–67, 71–77, and 81 are rejected under 35 U.S.C.
§ 103(a) as unpatentable over Kahn (US 2003/0065669 A1, pub. Apr. 3,
2003) and Hendrickson (US 5,740,800, iss. Apr. 21, 1998).
Claims 58–60, 68–70, and 78–80 are rejected under 35 U.S.C.
§ 103(a) as unpatentable over Kahn, Hendrickson, and Dettinger
(US 7,089,235 B2, iss. Aug. 8, 2006).

ANALYSIS
Independent claim 52 and dependent claim 53–61
We are persuaded by Appellant’s argument that the Examiner erred in
rejecting independent claim 52 under 35 U.S.C. § 103(a) because Kahn,
upon which the Examiner relies, fails to disclose or suggest limitation [d] of
independent claim 52 which recites:
extract entries from among the selected entries which meet at
least one of a second sets of screening conditions comprising
time conditions each for extracting an entry that does not advance
to one of the workflow points within a predetermined time
expected to take to advance to the one workflow point.
(See Appeal Br. 23; see also Reply Br. 3).
The Examiner maintains that the rejection is proper, and cites
paragraphs 147–149, 194–196, and 199, as well as Figures 34–38 and
claims 1–13, of Kahn as disclosing the argued limitation (see Final Act. 4;
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see also Ans. 6). However, we agree with Appellant that there is nothing in
the cited portions that discloses or suggests the argued limitation.
Kahn is directed “to a system and method using medical informatics
primarily to predict study progress timelines based on easily modifiable
assumptions” (Kahn ¶ 2). More particularly, Kahn discloses
clinical trials are defined, managed and evaluated according to
an overall end-to-end system solution which covers both the
protocol design and the actual conduct of trials by clinical sites.
A protocol designer chooses a meta-model and preliminary
eligibility criteria list appropriate for the relevant disease
category, and encodes the clinical trial protocol, including
eligibility and patient workflow, into a machine-readable
protocol database. This protocol database then drives most
subsequent aspects of the trial.
(Id. ¶ 78; see also id. ¶¶ 147–148). Kahn further discloses that
[o]nce a patient is enrolled into a study, the protocol database
indicates to the clinician exactly what tasks are to be performed
at each patient visit. The workflow graph embedded in the
protocol database advantageously also instructs the proper time
for the clinician to obtain informed consent from a patient during
the eligibility screening process, and when to perform future
tasks, such as the acceptable date range for the next patient visit.
(Id. ¶ 79). Kahn discloses “[t]he use of a machine-readable protocol
database to store most significant aspects of a clinical trial protocol enables
the development of automated tools to analyze the protocol and provide
timely information to the protocol designer and the sponsor” (id. ¶ 81).
Kahn still further discloses that
[o]nce these time indications are embedded into a machine-
readable protocol database, a problem-solving method is used to
automatically extract the time duration expected or predicted for
a patient to traverse each separate phase of the protocol. Such
durations are provided to a simulation engine, which
automatically generates timeline forecasts of patient progress
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through at least part of the workflow tasks prescribed by the
protocol.
(Id. ¶ 82; see also id. ¶¶ 194–195). Kahn also discloses “[t]he ability to re-
run the simulation quickly is also highly desirable for study sponsors
keeping track of actual study progress” to “learn not only how far off the
forecasted number of patients in each protocol phase are from the actual
number at that point in time, but also how the difference will impact the
study completion date” (id. ¶ 196).
The difficulty with the Examiner’s analysis, as Appellant points out, is
that
[p]aragraphs 147–149 discuss development of criteria for
selecting patients eligible for clinical trials and have nothing to
do with claim limitation [d], which requires a second selection of
already selected entries based on whether or not an entry has
advanced to a point as scheduled. Paragraphs 194–196 discuss
simulation of timeline which indicates an expected patient
progress through a clinical trial and again have nothing to do with
claim limitation [[d]].
(Appeal Br. 23). In this regard, we note the cited portions of Kahn
relate to selecting a meta-model for a clinical trial protocol under
development (Kahn ¶¶ 147–149) and to “the output of the simulation
engine 3410 [which] indicates a timeline of expected patient progress
through a clinical trial conducted according to a clinical trial protocol
represented in a machine readable iCP database” (id. ¶ 194; see also id.
¶¶ 92, 195–196, 199; Figs. 34–38), but do not disclose or suggest “extracting
an entry that does not advance to one of the workflow points within a
predetermined time expected to take to advance to the one workflow point,”
as limitation [d] of independent claim 52 requires.
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Responding to Appellant’s argument in the Response to Argument
section of the Answer, the Examiner takes the position that
the cited prior art discloses the feature stating “ . . . extracting the
required information from the electronically stored iCP database
and writing it to a file for subsequent importation into the
simulation engine 3410, an Application Programming Interface
(API) can be provided for the simulation engine 3410 to extract
the information directly, as needed, from the iCP. In an
embodiment, instead of extracting duration information from the
iCP for the three coarse stages (screening, treatment[,] and
follow-up).”
(Ans. 6 (citing Kahn ¶ 199)). However, as discussed above, the cited
portion of Kahn is directed to timeline forecasting, i.e., “the output of the
simulation engine 3410 indicates a timeline of expected patient progress
through a clinical trial conducted according to a clinical trial protocol”
(Kahn ¶ 194; see also id. ¶¶ 194–196, 199; Figs. 34–38). We fail to see, and
the Examiner does not adequately explain, how Kahn’s disclosure regarding
timeline forecasting discloses or suggests “extracting an entry that does not
advance to one of the workflow points within a predetermined time expected
to take to advance to the one workflow point,” as called for by limitation [d]
of independent claim 52. The Examiner does not rely on Hendrickson to
address the argued limitation (see Final Act. 4).
In view of the foregoing, we do not sustain the Examiner’s rejection
of independent claim 52 under 35 U.S.C. § 103(a). For the same reasons, we
also do not sustain the Examiner’s rejections of claims 53–61, which depend
therefrom.

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Independent claims 62 and 72, and dependent claims 63–71 and 73–81
Each of independent claims 62 and 72 includes a limitation similar to
limitation [d] in independent claim 52, and is rejected based on the same
rationale applied with respect to independent claim 52 (see Final Act. 6–7,
8–9). Thus, for the same reasons, we also do not sustain the Examiner’s
rejection of independent claims 62 and 72 under 35 U.S.C. § 103(a). For the
same reasons, we also do not sustain the Examiner’s rejections of claims 63–
71 and 73–81, which depend therefrom.

DECISION
The Examiner’s rejections of claims 52–81 under 35 U.S.C. § 103(a)
are reversed.

REVERSED