Ex Parte Bobasheva et al

Patent Trial and Appeal Board

Apr 28, 2016

12938735 (P.T.A.B. Apr. 28, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/938,735 11/03/2010
22878 7590 05/02/2016
Agilent Technologies, Inc, in care of:
CPA Global
P. 0. Box 52050
Minneapolis, MN 55402
FIRST NAMED INVENTOR
Anna Bobasheva
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.
20100217-01 4030
EXAMINER
BARBEE, MANUELL
ART UNIT PAPER NUMBER
2864
NOTIFICATION DATE DELIVERY MODE
05/02/2016 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):
IPOPS.LEGAL@agilent.com
Agilentdocketing@cpaglobal.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ANNA BOBASHEVA, DEON SMIT, and
GEORGE BRYAN CRIST
Appeal2014-007497
Application 12/938,735
Technology Center 2800
Before MARK NAGUMO, N. WHITNEY WILSON, and
MONTE T. SQUIRE, Administrative Patent Judges.
WILSON, Administrative Patent Judge.
DECISION ON APPEAL
Appellants 1 appeal under 35 U.S.C. § 134(a) from the Examiner's
August 28, 2013 decision finally rejecting claims 1-23 ("Final Act."). We
have jurisdiction over the appeal under 35 U.S.C. § 6(b ).
We affirm.
1 Appellants identify the Real Party in Interest as Agilent Technologies, Inc.
(Appeal Br. 3).
Appeal2014-007497
Application 12/938,735
CLAHvIED SUBJECT ivIATTER
Appellants' invention is directed to a method for acquiring and
managing measurement data relating to the operating parameters of a
dissolution tester (Abstract). The Specification states that dissolution testing
is often performed as part of preparing and evaluating soluble materials such
as pharmaceutical dosage forms (Spec. i-f 2). According to the Specification,
regulatory requirements demand that dissolution testing equipment must
operate within certain parameters (id. i-f 3). Details of the method are set
forth in independent claim 1, which is reproduced below from the Claims
Appendix of the Appeal Brief (key claim limitations in italics):
1. A method for acquiring and managing measurement
data relating to operating parameters of a dissolution tester, the
dissolution tester including a vessel support plate, a plurality of
vessels mounted to the vessel support plate, a drive unit, and a
plurality of shafts movable by the drive unit into the respective
vessels and rotatable by the drive unit, the method comprising:
(a) measuring a plurality of operating parameters of the
dissolution tester by operating a plurality of sensors
communicating with the dissolution tester;
(b) transmitting the measured operating parameters from
the sensors to a user computing device communicating with the
sensors;
( c) determining whether the measured operating
parameters transmitted to the user computer device are in
compliance or are not in compliance with one or more
standards, by comparing the measured operating parameters
with a plurality of corresponding predefined values; and
( d) storing the measured operating parameters and
indications of compliance or non-compliance of each measured
operating parameter as a data record in a memory
communicating with the user computing device.
2
Appeal2014-007497
Application 12/938,735
REJECTIONS2
I. Claims 1-8, 11-14, 16-20, 22, and 23 are rejected under
35 U.S.C. § 103(a) as being unpatentable over Duckett3 in view ofHallworth4
and Roinestad. 5
II. Claims 9, 10, and 21 are rejected under 35 U.S.C. § 103(a) as
being unpatentable over Duckett in view of Hall worth, Roinestad, and
Cheng. 6
III. Claim 15 is rejected under 35 U.S.C. § 103(a) as being
unpatentable over Duckett in view of Hall worth, Roinestad, and Sekizawa. 7
DISCUSSION
Appellants do not separately argue any of the claims (see, Appeal Br.
8-14). Accordingly, we limit our discussion to claim 1.
The Examiner finds that Duckett discloses each element of claim 1,
except that Duckett does not explicitly disclose steps (c) or (d) from claim 1
(Final Act. 3--4, citing Duckett, FIGS. 2 and 3A, i-fi-150, 54, 57). The
Examiner also finds that Hallworth teaches that, for regulatory reasons,
pharmaceutical instruments (like a dissolution tester) have to be calibrated,
with records kept of the calibration tests (Final Act. 4, citing Hallworth 1, 2,
2 The Examiner withdrew the rejection of claims 5, 12, and 21 under 35
U.S.C. § 112, second paragraph which was set forth in the Final Action
(Ans. 3). Accordingly, that rejection is not before us.
3 Duckett et al., U.S. Patent Pub. 2001/0052269 Al, published December 20, 2001.
4 Hallworth, Technical Document Review: GAMP Good Practice Guide:
Calibration Management, Particle Measuring Systems (2008).
5 Roinestad et al., U.S. Patent No. 6,174,497 Bl, issued January 16, 2001.
6 Cheng et al., U.S. Patent Pub. 2007/0276612 Al, published November 29, 2007.
7 Sekizawa et al., U.S. Patent No. 7,469,608 B2, issued December 30, 2008.
3
Appeal2014-007497
Application 12/938,735
4, and 5). The Examiner further finds that Roinestad discloses that it was
known in the art for a dissolution apparatus with a processor to perform
comparative analysis and store the analysis in memory (id., citing Roinestad,
5:42-57, 6: 1-5, and 8:30-39). The Examiner concludes that it would have
been obvious:
"to modify the acquiring and managing measurement data as
disclosed in Duckett, to further include the steps of ( 1)
determining whether the measured operating parameters
transmitted to the user computer device are in compliance or are
not in compliance with one or more standards, by comparing
the measured operating parameters with a plurality of
corresponding predefined values and (2) storing the measured
operating parameters and indications of compliance or non-
compliance of each measured operating parameter as a data
record in a memory communicating with the user computing
device, based on the teachings of Hall worth and Roinestad, to
ensure that the calibration records are readily available. Storing
records in an electronic format ensures that they are readily
available because they can easily be retrieved since they are
stored in one location. In contrast; paper records may not be
readily available if some of the paper documents get lost or
misplaced. When combined with Duckett, the control/ display
console of Duckett in view of Hall worth and Roinestad will
perform the determination step and store the results in memory.
Ans. 4-5.
Appellants argue that the Examiner has not made out a prima facie
case of obviousness because the cited art does not disclose (1) "measuring a
plurality of operating parameters of the dissolution tester" as set forth in
step (a) of claim 1, or (2) "determining whether the measured operating
parameters transmitted to the user computer device are in compliance or are
not in compliance with one or more standards, by comparing the measured
4
Appeal2014-007497
Application 12/938,735
operating parameters with a plurality of corresponding predefined values" as
set forth in step (c) of claim 1 (Appeal Br. 8-10).
While Appellants concede that Hallworth describes a need for
calibration, they contend that Hallworth does not teach or suggest
determining whether the measured operating parameters are in compliance
with one or more standards "by comparing the measured operating
parameters with a plurality of corresponding predefined values" (Appeal Br.
10). Appellants also acknowledge that Hall worth provides an "allusion" to
the means or methods of the calibration process (Reply Br. 5).
Appellants appear to argue that Hallworth does not explicitly state that
it compares measured operating parameters with a plurality of corresponding
predefined values (id.) However, as found by the Examiner, Hallworth
specifically discloses that the calibration records which should be kept for
regulatory compliance include: the scheduled date for calibration and
frequency, accuracy and failure limits, calibration range, and a non-
conformance report (Ans. 6, citing Hallworth 5). The Examiner further
finds that in order to create a non-conformance report as disclosed in
Hallworth, a person of skill in the art would have to determine that the
measurements made by Duckett (i.e., height and center positioning) are not
in compliance with the regulatory requirements (Ans. 7). Such a
determination would necessarily entail comparing the measured operating
parameters with the corresponding pre-defined values, as required by the
claim (id.).
What a reference teaches or suggests to a person of ordinary skill is
not limited to what that reference specifically "talks about" or what is
specifically "mentioned" or "written" in the reference. Syntex (U.S.A.) LLC
5
Appeal2014-007497
Application 12/938,735
v. Apotex, Inc. 407 F.3d 1371, 1380 (Fed. Cir. 2005). Indeed, "a person of
ordinary skill is also a person of ordinary creativity, not an automaton."
KSR v. Teleflex, 550 U.S. 398, 421 (2007). In this instance, the Examiner
has provided a reasonable explanation for why the claimed step of
"determining whether the measured operating parameters transmitted to the
user computer device are in compliance or are not in compliance with one
or more standards, by comparing the measured operating parameters with a
plurality of corresponding predefined values" would have been obvious to a
person of skill in the art in view of Duckett and Hall worth.
Accordingly, in view of the evidence of record, we do not discern
reversible error in the Examiner's determination that claimed step (c) would
have been obvious.
The Examiner finds that Duckett discloses making both shaft
centerline and height measurements, as shown below in the annotated
version of Duckett's FIG. 1 (see also Duckett, i-f 50):
FIG, 1
6
Appeal2014-007497
Application 12/938,735
This annotated version of Duckett's FIG. 1 shows a cross-sectional view of a
paddle shaft installed in a vessel in which Duckett's method is implemented.
The Examiner finds that these two measurements correspond to the
claimed measurement of "a plurality of operating parameters" (Final Act. 3;
Ans. 4--5). In response to this finding, Appellants contend that Duckett does
not disclose "measuring a plurality of operating parameters" (Appeal Br.
11 ). Appellants argue that Duckett discloses only measuring a single value
(i.e., the shaft position, which includes both the shaft height and the shaft
centerline position), which does not meet the claim recitation of "measuring
a plurality of operating parameters" (Appeal Br. 11-12).
However, as explained in detail by the Examiner, Duckett teaches
using two different sensors to measure ( 1) the lateral position of the shaft,
and (2) the vertical position of the shaft. Thus, two different operating
parameters (i.e., a plurality) are measured in Duckett's system. Appellants
appear to be arguing that a "plurality of operating parameters" must relate to
different physical portions of the dissolution tester. However, "the PTO
must give claims their broadest reasonable construction consistent with the
specification .... Therefore, we look to the specification to see if it provides
a definition for claim terms, but otherwise apply a broad interpretation." In
re ICON Health & Fitness, Inc., 496 F.3d 1374, 1379 (Fed. Cir. 2007).
Appellants have not pointed to anything in the Specification which requires
that the "plurality of operating parameters of the dissolution tester" which
are measured in step (a) of the claimed method be related to different
physical portions of the dissolution tester. Thus, using the broadest
reasonable construction of the phrase "plurality of operating parameters,"
7
Appeal2014-007497
Application 12/938,735
Appellants have not shown error in the Examiner's determination that
Duckett teaches step (a) of the claimed method.
CONCLUSION
We AFFIRM the rejection of claims 1-8, 11-14, 16-20, 22, and 23 under
35 U.S.C. § 103(a) as being unpatentable over Duckett in view of Hallworth
and Roinestad.
We AFFIRM the rejection of claims 9, 10, and 21 are rejected under
35 U.S.C. § 103(a) as being unpatentable over Duckett in view of Hallworth,
Roinestad, and Cheng.
We AFFIRM the rejection of claim 15 under 35 U.S.C. § 103(a) as
being unpatentable over Duckett in view of Hall worth, Roinestad, and
Sekizawa.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(l )(iv).
AFFIRMED
8