Ex Parte Tkaczyk et al

Board of Patent Appeals and Interferences

Aug 9, 2010

10065159 (B.P.A.I. Aug. 9, 2010)

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.
10/065,159 09/23/2002 John Eric Tkaczyk RD-28334 4870
41838 7590 08/09/2010
GENERAL ELECTRIC COMPANY (PCPI)
C/O FLETCHER YODER
P. O. BOX 692289
HOUSTON, TX 77269-2289
EXAMINER
NGUYEN, TRAN N
ART UNIT PAPER NUMBER
3626
MAIL DATE DELIVERY MODE
08/09/2010 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte JOHN ERIC TKACZYK, MARIA LATROU,
and NARESH KESAVAN RAO
____________

Appeal 2009-009112
Application 10/065,159
Technology Center 3600
____________

Before: MURRIEL E. CRAWFORD, ANTON W. FETTING and
JOSEPH A. FISCHETTI, Administrative Patent Judges.

CRAWFORD, Administrative Patent Judge.

DECISION ON APPEAL1

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.

Appeal 2009-009112
Application 10/065,159

2
STATEMENT OF THE CASE
This is an appeal from the final rejection of claims 1-40. We have
jurisdiction to review the case under 35 U.S.C. §§ 134 and 6 (2002).
The claimed invention is directed to network-based systems and
methods for managing clinical research information (Spec. para. [0001]).
Claim 1, reproduced below, is further illustrative of the claimed subject
matter.
1. A method for managing clinical study (CS) information
for a clinical research entity via a server system coupled to a
centralized database and at least one client system, said method
comprising:
receiving at the server system CS information relating to at
least one patient involved in a clinical study, the CS information being
entered through a user selected template displayed on the client
system, wherein the user selected template is selected from a plurality
of templates stored in a centralized database, each of the plurality of
templates configured to correspond to specific clinical studies;
storing CS information received at the server system in the
centralized database;
tracking CS information stored in the centralized database;
updating the centralized database periodically with newly
received information to maintain CS information; and
providing CS information in response to an inquiry.
The references of record relied upon by the Examiner as evidence of
obviousness are:
Goldwasser US 4,737,921 Apr. 12, 1988
Brown US 6,196,970 B1 Mar. 06, 2001
Rice US 2002/0042723 A1 Apr. 11, 2002
Appellants Admitted Prior Art (hereinafter “AAPA”).
Claims 1-16 stand rejected under 35 U.S.C. § 112, second paragraph,
for indefiniteness; claims 1-3, 6-9, 13-14, 16-19, 22-25, 29-30, 32-33, and
36-38 stand rejected under 35 U.S.C. § 102(b) as being anticipated by
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Brown; claims 4-5, 15, 20-21, 31, and 34-35 stand rejected under 35 U.S.C.
§ 102(b) as anticipated by Brown, or, in the alternative, under 35 U.S.C. §
103(a) as unpatentable over Brown in view of Goldwasser; claims 10-11,
26-27, and 39-40 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over Brown in view of Rice; and claims 12 and 28 stand rejected under 35
U.S.C. § 103(a) as unpatentable over Brown in view of AAPA.
We REVERSE.

ISSUES
Did the Examiner err in asserting that the term “tracking,” as recited
in independent claim 1, is indefinite?
Did the Examiner err in asserting that Brown anticipates “each of [a]
plurality of templates configured to correspond to specific clinical studies,”
as recited in independent claims 1, 14, 17, 30, and 33?

FINDINGS OF FACT
Specification
The Specification discloses that CRCS utilizes a plurality of
standardized templates for inputting CS data for a clinical study. CRCS
enables a supervisor to manage at least one clinical study (para. [0015]).
Tracking component 66 tracks and cross-references data, including
modifying existing data (para. [0028]).
In one embodiment, when a user creates a new clinical study, the user
selects a create a new clinical study button within system 10. System 10
then displays a standardized template wherein all the fields within the
template are available for use. Additionally, specific fields common to
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many clinical studies can be selected from a drop down list, check boxes, or
other manner for entering data could be used. Data is then entered by a user
in other fields within the standardized template. In another embodiment,
certain fields within a standardized template may be automatically filled
based on the type of medical application or type of treatment being utilized
to treat a patient (para. [0036]).

Brown
Brown discloses a system 100 to collect and analyze data from human
subjects engaged in medical research using a protocol or other intelligent
message, which acts in place of a researcher, investigator, clinician, or other
medical expert (col. 4, ll. 63-67).
At a step 206 the set of research subjects 111 view some portion of the
protocol 131 that was sent to the set of research subject devices 110 by
looking at a presentation screen or other output element 112 contained in the
research subject device 110 (col. 6, ll. 19-23).
At a step 216, the medical research expert 121 review the updated
information and protocol 131 and the other information input by the set of
research subjects 111 and either leave the updated research information and
protocol unchanged or modify it as necessary (col. 7, ll. 1-6).

ANALYSIS
Tracking and Updating
We are persuaded that the Examiner erred in asserting that the term
“tracking,” as recited in independent claim 1, is indefinite (App. Br. 10-14;
Reply Br. 5-6). While we agree with the Examiner that Appellants do not
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provide an explicit definition for either tracking or updating, it is a canon of
claim construction that two distinct claim elements should be given full
effect. See Unique Concepts, Inc. v. Brown, 939 F.2d 1558, 1563 (Fed. Cir.
1991). When interpreted in such a light, and in view of tracking component
66 set forth in the Specification, one of ordinary skill would understand that
“tracking” denotes a passive observation of data in the centralized database,
while “updating” denotes actively changing the data in the centralized
database. While we again agree with the Examiner that the disclosure of
tracking component 66 is a bit confusing in that it performs all of tracking,
cross-referencing, and modifying data (para. [0028]), the fact that tracking
component 66 performs both tracking and updating functions does not
conflict with the fact that the two functions are discrete.

Plurality of Templates Configured to Correspond to Specific Clinical
Studies
We are persuaded that the Examiner erred in asserting that Brown
anticipates “each of [a] plurality of templates configured to correspond to
specific clinical studies,” as recited in independent claims 1, 14, 17, 30, and
33 (App. Br. 30-32). We disagree that successive updates of the same
protocol 131 correspond to a plurality of templates. Most prominently, the
Examiner has not shown where Brown discloses that previous versions of
protocol 131 are stored.
Moreover, even assuming arguendo that successive updates of the
same protocol 131 correspond to a plurality of templates, and that the
automatic selection of the “latest version” of protocol 131 corresponds to a
“user selected template,” all versions of protocol 131 are for the same
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specific clinical study, and not “studies” as claimed. While we acknowledge
the Examiner’s point that “different, separate, and distinct clinical studies,”
is not explicitly recited (Exam’r’s Ans. 47-48) (emphasis omitted), a
combination of the context of “specific clinical studies” is set forth in
Appellants’ Specification (paras. [0015], [0036]) and the use of the plural
“studies” in the claim requires a claim construction that the “specific clinical
studies” are different, separate, and distinct.

REVERSED

hh

GENERAL ELECTRIC COMPANY (PCPI)
C/O FLETCHER YODER
P.O. BOX 692289
HOUSTON, TX 77269-2289