Ex Parte Ikeguchi et al

Patent Trial and Appeal Board

Apr 26, 2016

12817458 (P.T.A.B. Apr. 26, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/817,458 06/17/2010
23869 7590
Hoffmann & Baron LLP
6900 Jericho Turnpike
Syosset, NY 11791
04/27/2016
FIRST NAMED INVENTOR
Edward F. Ikeguchi
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.
1851-17 CIP/RCE/CON 5599
EXAMINER
RAJ,RAJIV J
ART UNIT PAPER NUMBER
3626
MAILDATE DELIVERY MODE
04/27/2016 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 EDWARD F. IKEGUCHI, GLEN M. De VRIES,
TAREK A. SHERIF, and EDWIN GOODMAN
Appeal2014-000364
Application 12/817 ,458 1
Technology Center 3600
Before HUBERT C. LORIN, BIBHU R. MOHANTY, and
BRADLEY B. BAY AT, Administrative Patent Judges.
LORIN, 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 1-30.2 We have jurisdiction under 35 U.S.C. § 6(b)
(2002).
SUMMARY OF DECISION
We REVERSE.
1 The Appellants identify Medidata Solutions, Inc. as the real party in
interest. App. Br. 2.
2 Although claims 31-36 are included in the statement of the rejection, the
Examiner did not provide a rejection for these claims. See Final Act. 3-16.
Therefore, claims 31-36 are not before us on appeal.
Appeal2014-000364
Application 12/817,458
THE INVENTION
Claim 1, reproduced below, is illustrative of the subject matter on
appeal.
1. A computer readable storage medium comprising computer
executable instructions to analyze data in an ongoing clinical
trial, the instructions when executed by a processor, cause the
processer to:
group trial data associated with the ongoing blinded
clinical trial into groups according to study arms associated with
subjects in the ongoing blinded clinical trial without identifying
the subjects associated with the trial data in the groups;
calculate a statistical term of interest associated with a
parameter in the trial data among the groups in the ongoing
clinical trial; and
determine whether the statistical term of interest indicates
an occurrence of a statistically significant event in the ongoing
clinical trial.
THE REJECTION
The Examiner relies upon the following as evidence of
unpatentability:
Becker I
Becker II
US 2004/0267570 Al
US 2003/0088365 Al
Dec. 30, 2004
May 8, 2003
Claims 1-30 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Becker I and Becker II.
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Appeal2014-000364
Application 12/817,458
ISSUE
Did the Examiner err in rejecting claims 1-36 under 35 U.S.C.
§ 103(a) as being unpatentable over Becker I and Becker II?
ANALYSIS
Independent claim 1 includes the limitation
group trial data associated with the ongoing blinded clinical trial
into groups according to study arms associated with subjects in
the ongoing blinded clinical trial without identifying the subjects
associated with the trial data in the groups.
The Examiner found said claim limitation disclosed in the Abstract,
paragraphs 2-26, 47-51, 57----66, 89-96, 116, 125, and claims 1-3 of Becker
II. See Final Act. 3; Ans. 4. According to the Examiner, Becker II
"discloses & teaches utilization for a plurality or group of subjects, as well
as individuals." Ans. 4.
The Appellants contend that the cited prior art does not disclose the
above limitation. App. Br. 4--9; Reply Br. 1-5. According to the
Appellants, the disclosure in Becker II of randomization of subjects does not
disclose or suggest the grouping of trial data without identifying the
subjects. Appellants argue, inter alia, that "randomization data is not trial
data." Reply Br. 2.
We agree with the Appellants.
Although the cited passages disclose double-blind clinical trials
having multiple patients in both placebo and drug treatment arms, we do not
see where the disputed limitation is disclosed. For example, paragraph 2 of
Becker II discloses the use of "randomized assigned subjects in double-
blind, placebo-controlled, clinical trials ('CTs')" as evidence to predict the
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Appeal2014-000364
Application 12/817,458
efficacy and safety of medical treatments or drugs in individual patients.
Although Becker II discloses the existence of study arms in blinded clinical
trials, there is no teaching of grouping trial data associated with an ongoing
blinded clinical trial into groups according to study arms without identifying
the subjects associated with the trial data in the groups as required by the
claims. Thus, the Examiner's conclusion that Becker II discloses the
disputed limitation does not follow from the evidence.
Independent claims 11 and 21 contain a similar limitation as claim 1
and were rejected based on the same findings. See Final Act. 7, 11.
Accordingly, for the same reasons, we find that a prima facie case of
obviousness has not been made out in the first instance for the subject matter
of claims 11 and 21.
CONCLUSION
The rejection of independent claims 1, 11, and 21under35 U.S.C.
§ 103(a) as unpatentable over Becker I and Becker II is not sustained. The
rejection of dependent claims 2-10, 12-20, and 22-30 is not sustained for
the same reasons given because independent claim 1, 11, and 21 from which
they depend is nonobvious ..
DECISION
The decision of the Examiner to reject claims 1-30 is reversed.
REVERSED
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