Siemens Healthcare Diagnostics Inc.

Patent Trials and Appeals Board

May 18, 2021

2021001183 (P.T.A.B. May. 18, 2021)

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.
14/912,776 02/18/2016 Alfonso Natale 2013P18755WOUS 5110
28524 7590 05/18/2021
SIEMENS CORPORATION
IP Dept - Mail Code INT-244
3850 Quadrangle Blvd
Orlando, FL 32817
EXAMINER
WISE, OLIVIA M.
ART UNIT PAPER NUMBER
1631
NOTIFICATION DATE DELIVERY MODE
05/18/2021 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):
ipdadmin.us@siemens.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte ALFONSO NATALE and ISRAEL FIGUEROA
____________

Appeal 2021-001183
Application 14/912,776
Technology Center 1600
____________

Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
TAWEN CHANG, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from Examiner’s
decision to reject claims 1–5, 7, 8, 10–13, 18, and 23–33 (Appeal Br. 2). We
have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the real party in interest as “Siemens
Healthcare Diagnostics, Inc.” (Appellant’s September 10, 2020, Appeal
Brief (Appeal Br.) 2).
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STATEMENT OF THE CASE
Appellant’s disclosure “relates generally to methods and apparatus for
preparing test plates for performing assays, such as by using polymerase
chain reaction (PCR) testing” (Spec.2 ¶ 2). Appellant’s claims 1 and 18 are
representative and reproduced below:
1. A method of operating a sample preparation apparatus,
comprising:
receiving in the sample preparation apparatus,
instructions selected from graphical user interface options to
run one of a dynamic assay or a fixed assay, wherein the
dynamic assay runs more than one assay type on a test plate and
the fixed assay runs one and only one assay type on the test
plate;
selecting to run either the dynamic assay or the fixed
assay in response to receiving the instructions in the sample
preparation apparatus;
running the dynamic assay in response to selecting the
dynamic assay, wherein running the dynamic assay comprises:
receiving instructions to run a first assay type and
a second assay type;
receiving one or more sample containers, each
sample container of the one or more sample containers
having a sample therein;
receiving assay orders to run on one or more
samples;
transferring portions of the samples to wells of an
extraction plate;
producing sample eluates by performing sample
processing of the samples in the wells of the extraction
plate;

2 Appellant’s February 18, 2016, Specification.
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defining, based on the assay orders, a first assay
region including wells on the test plate and a second
assay region including wells on the test plate;
generating drive signals to control one or more
robots to move sample eluates having the first assay type
run thereon only to wells in the first assay region and to
move sample eluates having the second assay type run
thereon only to wells in the second assay region; and
moving at least one of the one or more robots in
response to the drive signals to dispose the sample
eluates having the first assay type run thereon only to
wells in the first assay region and to move the sample
eluates having the second assay type run thereon only to
wells in the second assay region.
(Appeal Br. 21–22.)
18. A method of operating a sample preparation apparatus,
comprising:
receiving in the sample preparation apparatus,
instructions selected from graphical user interface options to
run one of a dynamic assay or a fixed assay, wherein the
dynamic assay runs more than one assay type on a test plate and
the fixed assay runs one and only one assay type on the test
plate;
selecting to run either the dynamic assay or the fixed
assay in response to receiving the instructions in the sample
preparation apparatus;
running the dynamic assay in response to selecting the
dynamic assay, wherein running the dynamic assay comprises:
providing a plurality of samples to be assayed in a
corresponding plurality of sample containers, one or
more of the plurality of sample containers including
sample identifiers;
reading the sample identifiers from the plurality of
sample containers;
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receiving assay orders to run assay types on the
plurality of samples;
selecting, based upon the assay orders and sample
identifiers, a number of assay types to run on the test
plate;
defining assay data sets for each of the assay types
including types and numbers of pre-processed controls
and post-processed controls;
preparing the plurality of samples and pre-
processed controls through to sample eluate and control
sample eluate in extraction plate wells of an extraction
plate;
defining, based on the assay data sets and the
number of pre-processed and post-processed controls, an
electronic plate map including multiple assay regions
including a plurality of test plate wells, wherein each of
the multiple assay regions includes a single continuous
region of wells, and wherein a different assay type is to
be performed in each of the multiple assay regions; and
controlling one or more robots to transfer sample
eluate from the extraction plate wells into the multiple
assay regions, wherein sample eluate having a first assay
type run thereon are moved only to wells in a first assay
region and sample eluate having a second assay type run
thereon are moved only to wells in a second assay region.
(Id. at 24–25.)

Grounds of rejection before this Panel for review:
Claims 1–4, 7, 8, 10–13, 30, and 33 stand rejected under 35 U.S.C.
§ 103 as unpatentable over the combination of Frank3 and DeSimas.4

3 Frank et al., US 2013/0157273 A1, published June 20, 2013.
4 DeSimas et al., US 2007/0112804 A1, published May 17, 2007.
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Claims 5 and 29 stand rejected under 35 U.S.C. § 103 as unpatentable
over the combination of Frank, DeSimas, and Bustin.5
Claims 18, 23–28, 31, and 32 stand rejected under 35 U.S.C. § 103 as
unpatentable over the combination of Frank, DeSimas, and Bustin.

ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
We adopt Examiner’s findings concerning the scope and content of
the prior art (Ans. 3–15), and provide the following for emphasis:
FF 1. Frank “relates to the field nucleic acid analysis. In particular, the
present invention relates to an improved method for the analysis of nucleic
acids in an automated system and to an analytical system for conducting
such improved analysis” (Frank ¶ 2; see also id. at Abstract; Non-Final Act.6
3, 9).
FF 2. Frank discloses:
[A] method for nucleic acid analysis involving the steps of
receiving sample tubes each containing a sample, receiving a
test request for each sample, said test request specifying one or
more assays to be conducted for said sample, generating one or
more sample aliquots of each sample depending on if one or
more assays are to be conducted, assigning each of the sample
aliquots to one or more test classes according to the assay
which is to be conducted for that sample aliquot, combining

5 Bustin et al., The MIQE Guidelines: Minimum Information for Publication
of Quantitative Real-Time PCR Experiments, 55 CLINICAL CHEMISTRY 611–
22 (2009).
6 Examiner’s May 11, 2020, Non-Final Office Action.
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sample aliquots belonging to the same test class into the same
batch, said batch comprising samples for which a first and
samples for which a second assay is to be conducted,
simultaneous amplification of nucleic acids contained in said
batch, conducting an analysis of the sample aliquots to
determine the presence and/or concentration of nucleic adds in
said sample aliquots.
(Frank ¶ 4; see also id. ¶ 17 (Frank discloses “[f]or each of the sample
aliquots it is then determined to which one or more test classes it belongs.
This determination is made according to the test request which specifies the
one or more assays to be conducted for a specific sample aliquot.”); Non-
Final Act. 3, 9.)
FF 3. Frank discloses:
The term batching as used herein does not means that sample
aliquots are mixed together to obtain a fluid mixture. It rather
means that the sample aliquots are combined in a way that they
can be processed simultaneously for at least the amplification
process of the assays. This can, e.g., be achieved by putting
sample aliquots into separate wells of the same microwell plate.
(Frank ¶ 61; see also Non-Final Act. 3, 4, 9.)
FF 4. Frank discloses:
If not enough samples are available which have to be tested for
the same NA, then today two options exist. Either it is waited
until further samples come in to fill the batch (i.e to complete
open positions in the used MWP) or the batch is run with fewer
samples as positions available in the plate (i.e. the MWP is
cycled with empty wells).
(Frank ¶ 14; see also Non-Final Act. 3, 9; cf. Spec. ¶ 47 (Appellant discloses
that the term “‘[f]ixed assay,’ as used herein means that one and only one
assay will be run for each eluted sample contained in each extraction plate
well, and that only one assay type per test plate is run.”).)

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FF 5. Frank discloses:
[T]he analytical system can be enhanced when mixed batches
(batches containing samples aliquots for which different assays
are to be conducted) are allowed as processing of incomplete
batches or less filled batches can be avoided. It has, however,
to be understood that the method does not at all require
that . . . only mixed batches are allowed.
(Frank ¶ 62; see also id. ¶ 15 (Frank discloses that its method and system
allows for “the analysis [of] different nucleic acids (i.e. different assays)
within the same batch.”); Non-Final Act. 3–4, 9; cf. Spec. ¶ 47 (Appellant
discloses that the term “‘[d]ynamic assay’ as used herein means that more
than one assay type will be run on the test plate.”).)
FF 6. Frank discloses:
[A] system for analyzing nucleic acid containing samples,
comprising a sample reception unit in which sample tubes each
containing a sample are received, a reader which reads
identifications on the sample tubes, a data management unit
which receives test requests for samples, said test requests are
specifying assays to be conducted for the samples, the data
management unit further receives sample tube identifications
from the reader, the data management unit determines how
many aliquots of a sample are necessary, assigns such sample
aliquots to test classes and provides the assignment to a control
unit, the control unit controls a pipettor to pipette sample
aliquots having the same test class assigned thereto into the
same batch of wells, the same or a further pipettor for pipetting
reagents into the batch of wells, a thermal unit for subjecting
the batch of wells to a thermal profile for amplifying nucleic
acids, a detection unit which detects signals from the batch of
wells, an evaluation unit which determines the presence and/or
quantity of nucleic acids in the wells of the batch.
(Frank ¶ 5; see also Non-Final Act. 3–4, 9–10.)

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FF 7. Examiner finds that Frank fails to disclose the receipt of
instructions selected from graphical user interface options to
run one of a dynamic assay and a fixed assay, defining assay
data sets including types and numbers of pre-processed and
post-processed controls, and defining an electronic plate map
including multiple assay regions of continuous wells [as set
forth in Appellant’s] claim 18 [and relies on DeSimas and
Bustin to make up for this deficiency].
(Non-Final Act. 11–13; see also id. at 5–6 (Examiner finds that Frank fails
to disclose the receipt of “instructions selected from graphical user interface
options, to run one of a dynamic assay or a fixed assay [as set forth in
Appellant’s] claim 1” and relies on DeSimas to make up for this
deficiency.).)
ANALYSIS
The rejection of claim 1 over the combination of Frank and DeSimas:
Based on the combination of Frank and DeSimas, Examiner concludes
that, at the time Appellant’s invention was made, it would have been prima
facie obvious “to combine the prior art teachings to arrive at the claimed
invention” (Non-Final Act. 6). As Examiner explains, DeSimas
discloses that the workflow application is able to provide a
simplified user interface for presenting highly technical
information so that an unsophisticated user can easily perform
assays and operate instruments that typically require specialized
knowledge. . . . Therefore, one of ordinary skill in the art
would have been motivated to utilize the workflow application
software taught by DeSimas . . . in the method of nucleic acid
analysis by Frank . . . in order to provide an interface to allow
more users to be able to perform the nucleic acid analysis
method. Furthermore, one of ordinary skill in the art would
predict that the software taught by DeSimas . . . could be
readily added to the method of Frank . . . with a reasonable
expectation of success since the method of Frank . . . includes
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the use of a computer with a control unit and the ability to
incorporate assay protocols.
(Non-Final Act. 6–7 (citing DeSimas ¶ 2).)
Frank discloses a method and system wherein aliquots of different
samples are batched, i.e. placed into separate wells of the same microwell
plate for simultaneous processing (see FF 1–3). Frank discloses “mixed
batches,” i.e. “batches containing sample[] aliquots for which different
assays are to be conducted” (FF 5). Frank’s “mixed batches” read on
Appellant’s “dynamic assay,” wherein more than one assay type will be run
on the test plate, i.e. microwell plate (see id.). Frank makes clear, however,
that its method and system “does not at all require that . . . only mixed
batches are allowed” (id.). Thus, Frank makes obvious non-mixed batches,
which reads on Appellant’s “fixed assay” (see id. at 4–5). Therefore, we are
not persuaded by Appellant’s contention that “[n]either Frank [n]or DeSimas
[t]each ‘the fixed assay runs one and only one assay type on the test plate’”
(Appeal Br. 12; see also id. at 12–16; see Reply Br. 6–7). For the same
reasons, we are not persuaded by Appellant’s contentions regarding Frank’s
nomenclature, i.e. “assay type” and “test class” (Appeal Br. 10–16; see also
Reply Br. 2–6).
Given the foregoing, it would have been clear to those of ordinary
skill in the art that Frank discloses a method and system that performs either
a fixed or dynamic assay. Thus, a user of Frank’s system, i.e. apparatus,
would have to instruct the apparatus to perform either a fixed or dynamic
assay. As Examiner explains, at the time of Appellant’s claimed invention, a
person of ordinary skill in the art would have found it prima facie obvious to
modify Frank’s system, i.e. apparatus, to include DeSimas’ workflow
application “in order to provide an interface to allow more users to be able to
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perform the nucleic acid analysis method,” i.e. a graphical user interface
with options to run one of a dynamic or fixed assay (Non-Final Act. 6–7
(citing DeSimas ¶ 2)). Thus, we are not persuaded by Appellant’s
contention that the combination of Frank and DeSimas fails to “teach or
suggest the limitation, ‘receiving in the sample preparation apparatus,
instructions selected from graphical user interface options to run one of a
dynamic assay or a fixed assay’” (Appeal Br. 16; see also id. at 16–19). For
the same reasons, we are not persuaded by Appellant’s contentions regarding
the graphical user interface options made obvious by the combination of
Frank and DeSimas (see Reply Br. 7).
Contrary to Appellant’s contention, the foregoing rationale is not
“merely [] conclusory,” but is instead “[t]he combination of familiar
elements according to known methods [that] . . . does no more than yield
predictable results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416
(2007). In this regard, we note that the obviousness inquiry “not only
permits, but requires, consideration of common knowledge and common
sense.” DyStar Textilfarben GmbH & Co. v. C.H. Patrick Co., 464 F.3d
1356, 1367 (Fed. Cir. 2006); see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398,
421 (2007) (eschewing “[r]igid preventative rules that deny factfinders
recourse to common sense”); Perfect Web Techs., Inc. v. Info USA, Inc., 587
F.3d 1324, 1329 (Fed. Cir. 2009) (explaining that the obviousness analysis
“may include recourse to logic, judgment, and common sense available to
the person of ordinary skill that do not necessarily require explication in any
reference or expert opinion”); Leapfrog Enters., Inc. v. Fisher–Price, Inc.,
485 F.3d 1157, 1161 (Fed. Cir. 2007) (emphasizing that “the common sense
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of those skilled in the art” can be sufficient to “demonstrate[] why some
combinations would have been obvious where others would not”).

The rejection of claim 5 over the combination of Frank, DeSimas, and
Bustin:
Based on the combination of Frank, DeSimas, and Bustin, Examiner
concludes that, at the time Appellant’s invention was made, it would have
been prima facie obvious “to combine the prior art teachings to arrive at the
claimed invention” (Non-Final Act. 8). As Examiner explains, Bustin
discloses that following the guidelines set forth in their
document will provide more reliable and unequivocal
interpretation of qPCR results. . . . Therefore, one of ordinary
skill in the art would have been motivated to utilize the control
and calibrator protocol taught by Bustin . . . in the method of
nucleic acid analysis by the combination of Frank . . . and
DeSimas . . . in order to improve the reliability of assay results.
Furthermore, one of ordinary skill in the art would predict that
the controls and calibration method taught by Bustin . . . could
be readily added to the method of Frank . . . and
DeSimas . . . with a reasonable expectation of success since the
method of Frank . . . and DeSimas . . . includes the ability to
incorporate assay protocols, such as the assay protocols defined
by Bustin.
(Non-Final Act. 8 (citing Bustin, Abstract).)
Appellant states that “dependent claims 5 and 29 stand or fall with
independent claim 1” (Appeal Br. 9). Having found no error in the rejection
of Appellant’s claim 1 over the combination of Frank and DeSimas, as
discussed above, we find no error in the rejection of Appellant’s claim 5
over the combination of Frank, DeSimas, and Bustin. Arguments not made
are waived. See 37 C.F.R. § 41.37(c)(1)(iv) (“[A]rguments or authorities not
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included in the [A]ppeal [B]rief will be refused consideration by the Board
for purposes of the present appeal.”).

The rejection of claim 18 over the combination of Frank, DeSimas, and
Bustin:
Based on the combination of Frank, DeSimas, and Bustin, Examiner
concludes that, at the time Appellant’s invention was made, it would have
been prima facie obvious “to combine the prior art teachings to arrive at the
claimed invention” (Non-Final Act. 14). As Examiner explains, DeSimas
discloses that the workflow application is able to provide a
simplified user interface for presenting highly technical
information so that an unsophisticated user can easily perform
assays and operate instruments that typically require specialized
knowledge. . . . Bustin . . . discloses that following the
guidelines set forth in their document will provide more reliable
and unequivocal interpretation of qPCR results. . . . Therefore,
one of ordinary skill in the art would have been motivated to
utilize the workflow application software taught by
DeSimas . . . and the control and calibrator protocol taught by
Bustin . . . in the method of nucleic acid analysis by
Frank . . . in order to improve the reliability of assay results as
well as provide an interface to allow more users to be able to
perform the nucleic acid analysis method. Furthermore, one of
ordinary skill in the art would predict that the software taught
by DeSimas . . . and the controls and calibration method taught
by Bustin . . . could be readily added to the method of
Frank . . . with a reasonable expectation of success since the
method of Frank . . . includes the use of a computer with a
control unit and the ability to incorporate assay protocols, such
as the assay protocols defined by Bustin.
(Non-Final Act. 14 (citing DeSimas ¶ 2; Bustin, Abstract).)
Having found no deficiency in the combination of Frank and
DeSimas, as discussed above, we are not persuaded by Appellant’s
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contention that “Bustin . . . fails to cure the deficiencies of DeSimas and
Frank” (Appeal Br. 20).
CONCLUSION
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness.
The rejection of claim 1 under 35 U.S.C. § 103 as unpatentable over
the combination of Frank and DeSimas is affirmed. Claims 2–4, 7, 8, 10–
13, 30, and 33 are not separately argued and fall with claim 1.7
The rejection of claim 5 under 35 U.S.C. § 103 as unpatentable over
the combination of Frank, DeSimas, and Bustin is affirmed. Claim 29 is not
separately argued and fall with claim 5.
The rejection of claim 18 under 35 U.S.C. § 103 as unpatentable over
the combination of Frank, DeSimas, and Bustin is affirmed. Claims 23–28,
31, and 32 are not separately argued and fall with claim 18.
DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–4, 7, 8,
10–13, 30,
33
103 Frank, DeSimas 1–4, 7, 8,
10–13, 30,
33

5, 29 103 Frank, DeSimas,
Bustin
5, 29
18, 23–28,
31, 32
103 Frank, DeSimas,
Bustin
18, 23–28,
31, 32

Overall
Outcome
1–5, 7, 8,
10–13, 18,
23–33

7 Appellant states that “[d]ependent claims 2–4, 7–8, 10–13, 30, and 33
stand or fall with independent claim 1” (Appeal Br. 9).
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TIME PERIOD FOR RESPONSE
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)(1)(iv) (2019).

AFFIRMED