Ex Parte Houriet et al

Patent Trial and Appeal Board

Nov 30, 2016

12692897 (P.T.A.B. Nov. 30, 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.
12/692,897 01/25/2010 John W. HOURIET JR. 10001-33U2 2989
570 7590 12/02/2016
PANITCH SCHWARZE BELISARIO & NADEL LLP
ONE COMMERCE SQUARE
2005 MARKET STREET, SUITE 2200
PHILADELPHIA, PA 19103
EXAMINER
LONG, FONYA M
ART UNIT PAPER NUMBER
3626
NOTIFICATION DATE DELIVERY MODE
12/02/2016 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
u sptomail @ panitchlaw. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JOHN W. HOURIET, JR. and JIANBO PENG
Appeal 2014-006860
Application 12/692,897
Technology Center 3600
Before BIBHU R. MOHANTY, NINA L. MEDLOCK, and
TARA L. HUTCHINGS, Administrative Patent Judges.
MOHANTY, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
The Appellants seek our review under 35 U.S.C. § 134 of the final
rejection of claims 1—36, which are all the claims pending in the application.
We have jurisdiction under 35 U.S.C. § 6(b).
SUMMARY OF THE DECISION
We REVERSE.
Appeal 2014-006860
Application 12/692,897
THE INVENTION
The Appellants’ claimed invention is directed to managing a database
lock for a clinical trial study (Spec., page 3, lines 8—9). Claim 1, reproduced
below, is representative of the subject matter on appeal.
1. An automated method of generating summary data regarding
task items that must occur to achieve a database lock for a clinical
trial study that is performed based on a previously defined
clinical trial protocol, the clinical trial study being managed using (i) a
processor, and (ii) a database in communication with the processor,
the database including clinical trial data and the status of the data for a
plurality of patients participating in the clinical trial study, the method
comprising:
(a) defining, using the processor, at least one clinical database
lock criterion for the study from at least a plurality of user-selected
subsets of the clinical trial data, wherein the clinical database
lock criterion is defined using the previously defined clinical trial
protocol;
(b) inputting into the processor:
(i) the at least one clinical database lock criterion for the
study, and
(ii) the clinical trial data and the status of the data, as
retrieved from the database, for the plurality of patients
participating in the clinical trial study as defined by the clinical
database lock criteria; and
(c) automatically and programmatically generating, using the
processor, summary data regarding task items that must occur to
achieve the database lock as defined by the at least one clinical
database lock criterion, using the clinical trial data and the status of
the data, wherein different summary data will be generated for
different clinical database lock criteria.
THE REJECTIONS
The following rejections are before us for review:
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Application 12/692,897
1. Claims 1—14, 16, 19-32, and 34 are rejected under 35 U.S.C.
§ 103(a) as unpatentable over Briegs et al. (US 7,054,823 Bl, issued May
30, 2006) (“Briegs”).
2. Claims 15 and 33 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Briegs and Shah (US 2004/0093240 Al, issued May 13,
2004).
3. Claims 17 and 35 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Briegs and Omni Comm’s TrialMaster (TrialMaster
brochure, Omni Comm Systems, Inc. (2007).
4. Claims 18 and 36 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Briegs and Rosenberg (US 2008/0270181 Al, published
Oct. 30, 2008.
FINDINGS OF FACT
We have determined that the findings of fact in the Analysis section
below are supported at least by a preponderance of the evidence.1
ANALYSIS
The Appellants argue that the rejection of claim 1 is improper because
the cited prior art fails to disclose elements of claim limitation (a) identified
above (App. Br. 9—13; Reply Br. 2—5).
In contrast, the Examiner has determined that the cited claim
limitation would have been obvious in view of the following portions of
1 See Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427 (Fed. Cir. 1988)
(explaining the general evidentiary standard for proceedings before the
Patent Office).
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Application 12/692,897
Briegs: the Abstract, col. 2:11—14, col. 2:35—43, col. 9:39-40, col. 24:12—
19, col. 25:11-12, and col. 31:24—34 (Ans. 2, 3, 9).
We agree with the Appellants. Claim limitation (a) requires:
(a) defining, using the processor, at least one clinical database
lock criterion for the study from at least a plurality of user-
selected subsets of the clinical trial data, wherein the clinical
database lock criterion is defined using the previously defined
clinical trial protocol.
(Claim 1, emphasis added). Initially we note the claimed distinction
between a “clinical trial study” and a “previously defined clinical trial
protocol” that is set forth in both the preamble and body of the claim. The
cited claim limitation requires “defining . . . at least one clinical database
lock criterion for the study from at least a plurality of user-selected subsets
of the clinical trial data . . . defined using the previously defined clinical
trial protocol.” Here, the above citations to Briegs do disclose disparate
elements of the claim limitation, but not in the specific manner claimed. For
example, the Abstract does disclose designing and monitoring clinical trials
and that protocols of prior clinical trials are stored in a database. However,
the Abstract fails to disclose a “database lock criterion for the study from at
least a plurality of user-selected subsets of the clinical trial data.” Briegs at
col. 15:10-22 does disclose changing the status from “‘Concept to Finalize’”
(locking from further change), but this also fails to disclose a “database lock
criterion for the study from at least a plurality of user-selected subsets of the
clinical trial data.” Even assuming arguendo that the cited portions of
Briegs describe the discrete elements of the argued claim limitation, the
rejection nonetheless lacks the requirements to show obviousness. Here,
there is no articulated reasoning with rational underpinnings for modifying
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Appeal 2014-006860
Application 12/692,897
the cited portions of Briegs to meet the argued claim limitation in the
specific manner claimed without impermissible hindsight. For these
reasons, the rejections of claim 1 and its dependent claims are not sustained.
The remaining independent claims contain limitations similar to the
one discussed above, and the rejections of these claims and their dependent
claims are not sustained for these same reasons.
CONCLUSIONS OF LAW
We conclude that Appellants have shown that the Examiner erred in
rejecting the claims as listed in the Rejections section above.
DECISION
The Examiner’s rejections of claims 1—36 are reversed.
REVERSED
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