Ex Parte Callier et al

Patent Trials and Appeals Board

Jun 17, 2019

13783065 - (D) (P.T.A.B. Jun. 17, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/783,065 03/01/2013
108547 7590 06/19/2019
McDermott Will & Emery LLP
500 North Capitol Street NW
Washington, DC 20001
FIRST NAMED INVENTOR
Rhys de Callier
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.
041896-0748 / 8105.USOO 8123
EXAMINER
MARCSISIN, ELLEN JEAN
ART UNIT PAPER NUMBER
1641
NOTIFICATION DATE DELIVERY MODE
06/19/2019 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):
mweipdocket@mwe.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RHYS DE CALLIER, RICHARD L. EGAN,
WILLIAM J. FERENCZY, and MICHAEL JON HALE
(APPLICANT: QUIDEL CORPORATION)
Appeal2018-000321
Application 13/783 ,065 1
Technology Center 1600
Before DONALD E. ADAMS, ERIC B. GRIMES, and
RICHARD M. LEBOVITZ, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL
This Appeal under 35 U.S.C. § 134(a) involves claims 1 and 4--12
(Final Act. 2). 2 Examiner entered rejections under 35 U.S.C. § l 12(b), 35
U.S.C. § 103(a), and obviousness-type double patenting. We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 Appellants identify "Quidel Corporation" as the real party in interest
(Appellants' April 10, 2017 Appeal Brief (Br.) 1 ).
2 Examiner's November 9, 2016 Final Office Action.
Appeal2018-000321
Application 13/783,065
STATEMENT OF THE CASE
Appellants' disclosure "relates to a system and an apparatus for
analysis of a sample to aid in medical diagnosis or detection of the presence
or absence of an analyte in the sample" (Spec. ,r 2). Claims 1, 10, and 11 are
representative and reproduced below:
1. A system, comprising:
a test device comprising:
(a) a label zone comprising
(i) a first population of mobilizable, detectable
particles for specific binding to a test analyte in a sample; and
(ii) a second population of mobilizable, detectable
particles for specific binding to a non-test analyte but not to the
test analyte; and
(b) a first detection site at a first position comprising a
first binding member having specific binding affinity for
detectable particles in the first population bound to the test
analyte; and
( c) a second detection site at a second position that is
separate from the first position, the second detection site
comprising a second binding member having specific binding
affinity for detectable particles in the second population bound
to the non-test analyte;
an analyzer comprising:
(1) a drawer dimensioned to receive the test
device,
(2) an optical system for detection of a
signal generated from the first population of particles at the first
position and the second population of particles at the second
position when each population reaches a specific and separate
position on the test device,
(3) a processor and memory resources for
control of a motor and for processing data from an optics
module, wherein the processor and memory resources are
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Application 13/783,065
configured to evaluate a sample using a ratio of signal detected
from all or a portion of the second population of particles to
signal detected from all or a portion of the first population of
particles (i) to determine a time insensitive cut-off value for the
analyzer, and (ii) to determine the presence or absence of
analyte in the sample.
(Br. 15 (emphasis added).)
10. The system of claim 1, wherein the test device is a lateral
flow immunoassay.
(Id. at 16.)
(Id.)
11. The system of claim 10, wherein one or both of the first
and second population of detectable particles is comprised of
particles comprised of a fluorescing lanthanide compound.
Claims 1 and 4--12 stand rejected under 35 U.S.C. § 112(b ).
Claims 1 and 4--10 stand rejected under 35 U.S.C. § I03(a) as
unpatentable over the combination of Polito 3 and Kuo. 4
Claims 1 and 4--10 stand rejected under 35 U.S.C. § I03(a) as
unpatentable over the combination of Polito, Kuo, and Maher. 5
Claims 11 and 12 stand rejected under 35 U.S.C. § I03(a) as
unpatentable over the combination of Polito, Kuo or Maher, and Hudak. 6
Claims 1 and 4--12 stand rejected under the judicially created doctrine
of obviousness-type double patenting as being unpatentable over the claims
of Egan7 in view of Polito.
3 Polito et al., US 6,136,610, issued Oct. 24, 2000.
4 Kuo et al., US 7,784,678 B2, issued Aug. 31, 2010.
5 Maher et al., US 2008/0081341 Al, published Apr. 3, 2008.
6 Hudak et al., US 2009/0142856 Al, published June 4, 2009.
7 Egan et al., US 9,207,181 B2, issued Dec. 8, 2015.
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Application 13/783,065
Claim Interpretation corresponding to 35 U.S.C. § 112(!):
FACTUAL FINDINGS (FF)
FF 1. Appellants' Figure 11 is reproduced below:
FIG.11
Appellants' "FIG. 11 is an illustration of the software architecture of an
apparatus" (Spec. ,r 34).
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Application 13/783,065
FF 2. Appellants' Figure 12 is reproduced below:
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FIG.12
Appellants' "FIG. 12 shows the sequence of events in one embodiment of a
measurement procedure where an apparatus as described herein interacts
with a test device, exemplified by an immunoassay" (Spec. ,r 35).
FF 3. Appellants disclose the closure of the drawer 458:
[I]nitiates a sequence of events ... comprised of the following.
The internal bar code reader scans the bar code on the test
device and receives information regarding the assay type ( e.g.,
influenza A/B, hCG, Strep A, RSV, etc.), the serial number and
the expiration date of the test device, and any other information
included on the bar code secured to the test device. In one
embodiment, a mirror is positioned to facilitate interaction of
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Appeal2018-000321
Application 13/783,065
the light beam from the internal bar code scanner and the bar
code label on the test device. It will be appreciated that the
internal bar code reader is an optional feature, as the
information on the bar code label can be entered into the
apparatus by a user using the key pad or via an external bar
code scanner. Based on the test assay type discerned from the
information on the bar code label or otherwise provided to the
apparatus processor, the apparatus initiates an algorithm stored
in the apparatus' memory for the assay for which the test device
is designed, and based on user defined selection of read-now
mode or walk-away mode, a protocol stored in memory
initiates. In walk-away mode the apparatus incubates for a
period of time, 460, prior to initiating a scan of the test device,
462; in read-now mode the apparatus does not wait for the
preset incubation time for that particular assay, and
immediately begins a scan of the test device, 462.
(Spec. ,r 96 ( emphasis omitted).)
FF 4. Appellants disclose:
The scan and evaluation of the test device, 462, comprises
another temperature check, 464, at the same or different
position from the first temperature check 452. The initiated
algorithm activates the optics system, including the stepper
motor that moves the optics module with respect to the test
device that is stationary in the apparatus. The optics system
searches for its home position, 466, ( described below) and then
conducts a scan of the measurement window, 468, in the
housing of the test device through which the reference/control
and test line(s) are visible. The motor in the optics system
moves the optics module incrementally from a defined start
point along the length of the measurement window in the test
device in accord with parameters defined by the algorithm for
the particular assay being conducted. As will be described in
more detail below, the optics module is moved in incremental
steps by the motor in the optics system along the length of the
test window, in a downstream to upstream direction with
respect to sample fluid flow on the test strip, wherein the optics
carriage stops at each incremental step or position to illuminate
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Application 13/783,065
the position, detect emitted light after illumination at that
position, before advancing upstream to the next position.
(Spec. ,r 97 (emphasis omitted).)
FF 5. Appellants disclose:
After collection of emitted light at each of the plurality of
incremental positions along the length of the test window, the
algorithm locates and evaluates the data in the data array that is
associated with the reference line, 470, and conducts a
qualitative, semiquantative or quantative analyte evaluation
using a cut-off algorithm, 4 72.
(Spec. ,r 98 (emphasis omitted).)
FF 6. Appellants' Figure 13A is reproduced below:
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Appellants' FIG. 13A illustrates an
exemplary test sequence for the apparatus described [in
Appellants' Specification, wherein the] start of the
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Appeal2018-000321
Application 13/783,065
measurement procedure is initiated, 490, by pressing a button or
switch on the apparatus. Information regarding the patient
(name, gender, age, etc.) is entered, 492, by the user via entry
using the keypad on the apparatus or via an external bar code
scanner. The drawer in the apparatus is opened using a button
on the apparatus and the test device is inserted into the drawer,
494. Closing of the drawer manually or automatically by the
apparatus initiates an automated sequence of events, 496. The
sequence includes reading the temperature at one or more
locations inside the apparatus, such as adjacent the test window,
and/or taking an ambient temperature reading, 498. If an
incubation time is commanded by a user selecting 'walk-away'
mode or by a pre-programmed requirement for a particular test
assay, an incubation time starts, 500. Upon completion of the
incubation time or if no incubation time is required or
commanded, the measurement sequence by the optics system
automatically initiates.
(Spec. ,II 00 ( emphasis omitted); see also id. (Appellants disclose "that the
test sequence is easily varied by simply varying the programming in the
software programs in the device, to alter the sequence of events, time
allocated to each event, etc., in a measurement procedure"); see generally
i136.)
FF 7. Appellants' Figure 13B is reproduced below:
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Appellants' FIG. 13B discloses
the measurement sequence by the optics system[, which]
includes activating the motor that moves the optics module,
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Appeal2018-000321
Application 13/783,065
504, and the optics module finding its home position, 506. A
temperature reading, 508, in the vicinity of the optics system
can be taken. At a first position along the optical read path that
corresponds with the test window on the test device inserted in
the apparatus, the illumination source in the optics module is
turned on and then off, and during the off period fluorescent
emission is detected by the photodetector in the optics module.
The detected emission is stored in memory, and the motor in
the optics system advances the optics module a fixed amount to
its next position, which in an embodiment is in a direct toward
the sample zone in the device so that measurement of the lines
in the test window occurs in a downstream to upstream
direction with respect to fluid flow on the test strip. After
completion of a predefined number of incremental steps along
the length of the test window and capture of light emission at
each step, 510, the optics module is returned to its home
position by the motor, 512, and the motor is powered off, 514.
(Spec. ,r 101 (emphasis omitted); see generally id. ,r 36.)
FF 8. Appellants disclose:
The algorithm stored in apparatus memory for that
particular assay then searches the data array for the peak
emissions for each of the test and reference lines, 516, to
calculate line intensities of peak area or peak height, 518. The
algorithm calculates results from the data array, 520, and stores
the results to memory, such as on the SD card inserted into the
device. The calculated result can be displayed to the screen on
the apparatus, or prompted to be printed by the user, or stored
in flash memory if needed, 522. A user can then instruct the
apparatus to open the drawer, to remove the test device, 524,
526, ending the measurement procedure, 528.
(Spec. ,r 102 ( emphasis omitted).)
FF 9. Appellants disclose:
The apparatus and the reference line on the test device
are designed to interact in several ways to ensure that the
correct result will be determined and reported. First, the
location of the reference line on the test device is used by the
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Application 13/783,065
algorithm in the apparatus to determine the relative locations of
the analyte-specific test lines on the test device. The software
program expects the reference line to be located within a
specific, pre-defined location range. The acceptable range for
the location of the reference line is based on the manufacturing
tolerance for placement of immunochemistry on the test strip,
for location of the test strip within the housing, and for
positioning of the test device ( test strip in the housing
(cassette)) within the drawer of the apparatus. Once the
reference line is located, the positions of each of the other test
lines and zones are determined by the algorithm and match the
locations of the various chemistries deposited on the test strip.
(Spec. ,r 104.)
FF 10. Appellants disclose:
The reference line also serves as a 'timer mechanism' for
the system, i.e., the apparatus and test strip. This is achieved by
programming the analyzer with an algorithm that uses the
signal ( e.g., RLU, RFU) from the reference line to determine a
cut-off value unique to the individual test strip inserted into the
apparatus, and against which signal from the test line(s) is
compared to determine a test result. As a skilled artisan will
appreciate, signal from a control, test or reference line on a test
strip has a strong dependency on incubation time; i.e, the
elapsed time from sample placement on the strip and visual
inspection of the line to determine a test result. . . . After the
incubation time, RFU from the test line was read with the
apparatus. The increase in RFU with increasing incubation
time, at every concentration level, is apparent from the data.
This data illustrates the problem with over incubation of a test
strip and false positives. For example, an apparatus that is
programmed with a fixed cut-off value of 7,000 RFU[], the cut-
off value representing the minimum RFU value for a positive
result, yields a valid result for a sample with a concentration of
10 mlU/mL only if the incubation time is at least 6 minutes. An
apparatus programmed with a fixed cut-off value of 7,000 RFU
would report a false negative for a sample with 10 mlU/mL
incubated for less than 6 minutes.
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Application 13/783,065
The system of the present invention resolves this issue,
by providing a reference line on the test strip that is used by the
apparatus to determine an individual cut-off value for the test
strip. In this approach, the signal (RFU, RLU) emitted from the
reference line is detected by the apparatus and mathematically
transformed to determine a cut-off value. This transformed cut-
off value represents an individualized value for the particular
test strip, and renders the test strip insensitive to incubation
time. . . . Signal from the reference line was mathematically
transformed using exponentiation to determine a transformed
cut-off value. In some embodiments, the exponentially
transformed signal was further adjusted by a constant value that
is empirically determined for each manufacturing lot of test
strips. . . . A skilled artisan will appreciate that for some assays
the same antibody for both spotting onto the test strip and
attaching to the conjugate beads can be used.
Signal detected from all or a portion of the population of
particles captured at the test line was compared to the
transformed cut-off value, and if the signal from the test line
was above the transformed cut-off value the apparatus reported
a positive test result. If the signal from the test line was below
the transformed cut-off value the apparatus reported a negative
result.
(Spec. ,r,r 107-109.)
FF 11. Appellants disclose:
At the end of a scan of lines in the window, the data collected
consists of emission signals from the test strip at the position
when LED is on (365 nm) and emission signals from test strip
at that position when LED is off. The difference between these
values at each position is taken, and stored in memory as a one-
dimensional array of the difference in emissivity at each
position when LED is on and when LED is off. The data
processing algorithm smoothes the data array using a local
polynomial regression ( of degree k) on the series of differential
emissivity values equally spaced in the series ( such as the
Savitzky-Golay method), to determine a smoothed value for
each point. In one embodiment, the algorithm smoothes 13
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points in the array, and the first derivative of the smoothed data
array is taken, and the peak/trough of the derivative peak height
is determined to be the raw cut-off value. The raw cut-off value
is transformed, preferably using a[ n] exponential transformation
( e.g, raising the raw signal cut-off value by an exponent in the
range of 1.2-1.9), to yield a transformed cut-off value unique to
the test strip. A signal to transformed cut-off ratio corresponds
to a simple ratio of the signal in RFU s obtained at a test line
divided by its transformed cutoff. Signal data that is collected
is processed using a Savitzky-Golay smoothing algorithm that
uses a weighted average smoothing method that reduces
unwanted electronic noise, while preserving actual test signals,
including maxima, minima and peak width with little impact on
their actual dimensions.
(Spec. ,r 113.)
ANALYSIS
On this record, Examiner finds that Appellants'
[ c] laim 1 as amended recites "a processor and memory
resources for control of the motor and for processing data from
the optics module[,]" and as a result invokes 35 U.S.C. 112(±)
because "a processor and memory resources" is a general
purpose computer and [Appellants'] originally filed
[S]pecification fails to include an algorithm to transform the
general purpose computer into a special purpose computer.
(Ans. 3--4; see also id. at 24 ("[I]t is [Examiner's] position ... that one of
ordinary skill would not know how to program the computer to perform the
necessary steps described, there no algorithm which meets the description
requirements, disclosed by Appellant to transform the general purpose
computer into a special purpose computer.")).) In this regard, Examiner
finds that the "generalized algorithm [set forth in Appellants'] originally
filed disclosure fails to provide specific structure in terms of a specific
algorithm such that [it] would limit the claim and transform the general
purpose computer into a special purpose computer" (Ans. 25).
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A processor, "microprocessor or general purpose computer lends
sufficient structure only to basic functions of a microprocessor. All other
computer-implemented functions require disclosure of an algorithm." EON
Corp. IP Holdings LLC v. AT&T Mobility LLC, 785 F.3d 616, 623 (Fed. Cir.
2015). Thus, "when the disclosed structure is a computer programmed to
carry out an algorithm, 'the disclosed structure is not the general purpose
computer, but rather that special purpose computer programmed to perform
the disclosed algorithm."' In re Aoyama, 656 F.3d 1293, 1297 (Fed. Cir.
2011) (quoting WMS Gaming, Inc. v. Int'! Game Tech., 184 F.3d 1339, 1349
(Fed. Cir. 1999)); see also Aristocrat Techs. Aust!. Pty Ltd. v. Int'! Game
Tech., 521 F.3d 1328, 1338 (Fed. Cir. 2008) (The written description of the
Specification must at least disclose the algorithm that transforms the general
purpose microprocessor to a special purpose computer programmed to
perform the disclosed algorithm.).
In response, Appellants direct attention to their Figures 11-13B and
paragraphs 96-98, 102, 104, 107-109, and 113 of their Specification to
support a contention that their "disclosure provides ample guidance and
details for how the processor is used to execute the claimed steps" (Br. 3; see
also id. at 4; see generally FF 1-11). We are not persuaded.
There is no doubt that Appellants' Specification and Figures recite the
word "algorithm" (see e.g., FF 2-5 and 8-11). Appellants, however, fail to
specifically identify, and we do not find, an evidentiary basis on this record
to support a finding that those of ordinary skill in this art would understand
"from [Appellants'] disclosed architecture [or] flow charts, how to
program/instruct the computer in order to perform the necessary steps"
recited in the claims (e.g., the "configured to" limitation of claim 1) (Ans.
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24--25). See, e.g., Medical Instrumentation and Diagnostics Corp. v. Elekta
AB, 344 F.3d 1205, 1211 (Fed. Cir. 2003) ("The duty of a patentee to clearly
link or associate structure with the claimed function is the quid pro quo for
allowing the patentee to express the claim in terms of function under section
112, paragraph 6.") (citing Budde v. Harley-Davidson, Inc., 250 F.3d 1369,
1377 (Fed. Cir. 2001)); see also Valmont Indus., Inc. v. Reinke Mfg. Co., Inc.
983 F.2d 1039, 1042 (Fed. Cir. 1993) ("The [A]pplicant must describe in the
patent [S]pecification some structure which performs the specified
function."). As Examiner explains, Appellants' Specification, including
Appellants' Figures,
fails to indicate how the processor is used in terms of how to
operate the process to execute the series of steps set forth. For
example, the cited flow chart[ s] fail to reference the "optics
module" and the Figures and cited disclosure fails to indicate an
algorithm or how it is controlled such to describe a specific
execution. Further, it is not readily apparent how one would
implement the generalized algorithm disclosed in order to use
the processor and memory resources themselves, in order to
"control the motor" and "process the data" that is obtained
"from an optics module" ( claim 1) to result in evaluation of the
sample.
(Ans. 25.)
For the foregoing reasons, we find no error in Examiner's claim
interpretation under 35 U.S.C. § 112(±) (see Ans. 2--4 and 23-25).
Definiteness:
ISSUE
Does the preponderance of evidence support Examiner's conclusion
that the phrases: "memory resources," "a processor and memory resources,"
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Application 13/783,065
and "wherein the processor and memory resources are configured to
evaluate a sample" are indefinite?
ANALYSIS
A claim element that is treated as a "means-plus-function" element
subject to the requirements of 35 U.S.C. § 112, sixth paragraph, is indefinite
under 35 U.S.C. § 112, second paragraph, if the specification does not
sufficiently identify adequate structure for performing the recited function.
See Aristocrat, 521 F.3d at 1336-37. Simply stated, to satisfy the
definiteness requirement, a means-plus-function claim requires sufficient
disclosure of the underlying structure.
Based on Examiner's claim interpretation, discussed above, Examiner
finds that Appellants' Specification "discloses no corresponding algorithm
associated with 'a processor and memory resources [ which are configured to
evaluate a sample]"' (Ans. 4). Thus, Examiner finds that the phrase
"'memory resources' does not further limit with regard to how the computer
or computer component performs the claimed function, and as such is
[indefinite]" (id. at 5). Examiner further finds the phrase "wherein the
processor and memory resources evaluate a sample" indefinite for reciting a
method step in an apparatus claim (id.).
In response, Appellants contend that their Specification "provides
adequate disclosure of the corresponding structure of the memory resources
in order to show sufficient detail about the memory resources," because their
Specification:
[D]iscloses that the processor and memory are configured with
an algorithm stored in the memory (see ,r [0096]). Further,
paragraph [0097] describes that the processor algorithm
activates the optics system to move the optics module and the
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manner in which the processor moves the optics module. This
paragraph also describes how the processor operates the optics
module to scan the test device. Further, and with regard to
processing the data, paragraphs [0098], [0102], [0104] (locating
and evaluating data in data array), [0107]-[0109] (use signal
from reference line to determine a cut-off value unique for the
test strip), and [0113] (smoothing the data array) provide
examples of guidance for how the processor and memory
controls process the data as presently claimed.
(Br. 4--5 (alteration original).) We are not persuaded.
As Examiner explains, Appellants' "original disclosure fails to
identify a sufficient algorithm associated with 'a processor and memory
resources,"' thus, the phrase "'memory resources' does not further limit with
regard to how the computer or computer component performs the claimed
function" (Ans. 26; see id. (Examiner finds that the phrase "'memory
resources' adds an undefined component to the computer system")). "In
summary, [Examiner finds that] because [Appellants'] disclosure fails to
provide structure, the processor and memory resources are interpreted as a
general purpose computer, and therefore the claims fail to provide adequate
disclosure of the corresponding structure to satisfy the requirements of 3 5
U.S.C. 112(b)" (id.).
In addition, Examiner correctly finds that "Appellant[ s] assert[] no
specific arguments against the rejection of claim 1 regarding the limitation
'wherein the processor and memory resources evaluate a sample' for being
indefinite as this particular limitation appears to recite a process step" (Ans.
26). For example, the claim states that the processor and memory are
configured to evaluate a sample using a signal ratio and determine a time-
insensitive cutoff value. Appellants identify disclosure in the Specification
where such steps are said to be described, but do not explain how such
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disclosure supports the claim. Thus, the claim is indefinite, as found by the
Examiner, because is it unclear how the recited function is performed.
CONCLUSION
The preponderance of evidence supports Examiner's conclusion that
the phrases: "memory resources," "a processor and memory resources," and
"wherein the processor and memory recourses evaluate a sample" are
indefinite. The rejection of Appellants' claim 1 under 35 U.S.C. § 112(b) is
affirmed. Appellants' claims 4--12 are not separately argued and fall with
Appellants' claim 1.
Obviousness:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
ANALYSIS
The rejection over the combination of Polito and Kuo:
Examiner finds that the limitation in Appellants' claim 1 that requires
the processor and memory resources to be configured to evaluate a sample
using a "ratio of signal from all or a portion [ of] the second population [ of
particles] to ... signal [ detected] from all or a portion of the first population
[ of particles] ... to determine a time insensitive cut[-]off value" for the
analyzer is "a recitation of the intended use of [Appellants'] claimed
invention" (Ans. 10). Thus, Examiner reasons that Polito is "considered
capable of using a ratio of signal detected from all or a portion of the second
population of particles to signal detected from all or a portion of the first
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population of particles to determine a cutoff value for the analyzer and to
determine the presence or absence of analyte in the sample" because
At col. 14, line 30 Polito et al. teach a cut-off ratio is specified
to determine whether a given measurement zone of an analyte
binding zone is positive or negative (indicate presence of
analyte); and at col. 14, line 38-40 teach cut-off as a variable
input to an algorithm ( referring to the algorithm for determining
analyte ), enabling the cut-off to be altered as the need arises.
At col. 6, lines 62-68, Polito et al. teach, exemplified with two
control lines, using the respective values of high and low
controls (i.e. control sites being equivalent to the second
detection site) to fit a standard curve, to be used as a calibration
parameter to determine the quantitative value for the analyte
binding zone (i.e. determine value (signal) from the first
population at the first detection site); further teaching (into col.
7), amount of control agent quantified can be mapped onto a
more meaningful measurement scale, such as relative intensity
(RI) (thereby incorporating signal from the second population),
and RI value can be assigned concentration values of analytes
of interest, teaching signal cutoff values may be derived from
the RI value (thereby addressing step by step algorithm for
determining a cutoff, i.e. addressing the use of signal detected
from all or a portion of the second population (the control) to
determine signal from the first population). Polito teach the
determination of the cutoff is carried out using the algorithm in
the analyzer system of Polito, which uses the signal from a
portion of the second population (i.e. signal from the control
zone) to determine the presence or absence of analyte in the
sample (i.e. signal at the detection zone). This is additionally
addressed at col. 14, lines 51-55; Polito et al. teach the
algorithm analyzes results by generating a baseline, quantifying
the measurement zones with respect to the control binding
zones and analyte binding zones.
(Ans. 9-10.) Stated differently, Examiner reasons that
because [Appellants'] [S]pecification provides no specific
structure (merely a general algorithm, insufficient structure to
satisfy the requirements under 35 U.S.C. 112(b)), the processor
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of Polito does address the processor as recited by the claims.
Specifically, Polito does teach a processor that is used to
determine a cutoff value based on signal detected at the control
population of particles. Polito teach the determination of the
cutoff is carried out using the algorithm in the analyzer system
(i.e. the processor is what is performing the algorithm, therefore
is carried out using the processor), which uses the signal from a
portion of the second population (i.e. signal from the control
zone) to determine the presence or absence of analyte in the
sample (i.e. signal at the detection zone). The algorithm of
Polito is performed by the processor, and as such it is the
processor which is determining the cutoff as described ....
Examiner maintains the position that the limitations are directed
toward intended use. The inquiry considered by ... Examiner
is whether or not the prior art structure is capable of performing
the intended use, and as such whether it meets the claim ....
Examiner has determined no structural difference between the
claimed invention and the prior art. . . . Furthermore, it is noted
that Appellant[s] provide[] no specific arguments and/or
evidence indicating why the structure disclosed by the prior art
would not be capable of performing the function as claimed,
such that would distinguish the claimed invention from the
cited prior art.
(Id. at 27-28.) We are not persuaded.
Notwithstanding Examiner's assertions to the contrary, Examiner
failed to establish an evidentiary basis on this record to support a conclusion
that Polito or the knowledge and ordinary creativity ascribed to one of skill
in this art would have led one to create a system comprising an analyzer that
is capable of performing the function discussed above. The "configured to"
language of Appellants' claim 1 imposes a structural limitation on the
analyzer of the claimed apparatus and, therefore, is not simply a recitation of
its intended use as Examiner asserts. See In re Noll, 545 F.2d 141, 148
(CCP A 1976) ("[T]he claimed invention ... comprises physical structure,
including storage devices and electrical components uniquely configured to
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perform specified functions through the physical properties of electrical
circuits to achieve controlled results. Appellant's programmed machine is
structurally different from a machine without that program."). \Vhen the
functional language is associated with prograrnming or some other structure
required to perfon11 the function, that programming or stn1cture must be
present in order to meet the claim limitation. See Typhoon Touch Techs.,
Inc. v. Dell, Inc., 659 F.3d 1376, 1380 (Fed. Cir. 2011); see also
Ultramercial, LLC v. Hulu, LLC, 657 F.3d 1323, 1328-29 (Fed. Cir. 2011)
("[P]rograrnming creates a new machine, because a general purpose
computer in effect becomes a special purpose cornputer once it is
programmed to perform particular functions pursuant to instructions from
program software."). The Examiner made no finding that the processor and
memory resources are configured to detect a signal "ratio" as required by all
the rejected claims.
Examiner relied upon Kuo to disclose "analytical strip device reader
apparatus ... comprising a delivering device for placing the analytical strip
inside the apparatus" and reasoned that Kuo's "delivering device (whkh
[Examiner] considered to be a drawer) serves the purpose of supporting the
analytical strip test and moving it into or out of the housing" (Ans. 11).
Examiner failed, however, to establish that Kuo makes up for the foregoing
deficiencv in Polito .
.;
For the foregoing reasons, we agree with Appellants' contention that
neither of Polito nor Kuo show or suggest a processor
configured to use a ratio of signal from a second population of
particles to signal detected from a first population of particles to
determine a time insensitive cut-off value for the analyzer, and
to determine the presence or absence of analyte in the sample.
(Br. 7.)
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The rejection over the combination of Polito, Kuo, and Maher:
Examiner relies on Maher to disclose, inter alia, an influenza
immunoassay (see Ans. 15-16). Therefore, based on the combination of
Polito, Kuo, and Maher, Examiner concludes that, at the time Appellants'
invention was made, it would have been prima facie obvious
to have targeted Influenza A as an analyte of interest, as taught
by Maher et al., when using the system for analysis as taught by
Polito[] specifically because Maher[] teach that influenza A is
one of the most commonly associated diseases in humans, that
it is highly contagious, and that rapid detection allows timely
administration of antiviral drugs; that this is important because
influenza is highly occurring among pediatric patients, and also
dangerous to the elderly population as a result of introducing
serious complications to elderly patients. The ordinarily skilled
artisan would have a reasonable expectation of success using
the system of Polito[] to target the analyte Influenza A because
the invention of Polito[] is capable of detection/analyzing
viruses and viral particles.
(Ans. 16.) We are not persuaded.
Examiner failed to establish an evidentiary basis on this record to
support a conclusion that Maher makes up for the foregoing deficiency in
the combination of Polito and Kuo. As Appellants explain:
Now here does Maher make any mention of a system including
a processor and memory resources configured to use a ratio of
signal detected from all or a portion of the second population of
particles to determine a time insensitive cut-off value for the
analyzer and determine the presence or absence of analyte in
the sample. Thus, the combined teaching of Polito, Kuo and
Maher fail to show or suggest a system comprising a processor
and memory resources that are configured to use a ratio of
signal detected from all or a portion of the second population of
particles to determine a time insensitive cut-off value for the
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analyzer and determine the presence or absence of analyte in
the sample as presently claimed.
(Br. 12 ( emphasis omitted)).
The rejection over the combination of Polito, Kuo or Maher, and Hudak:
Examiner relies on Hudak to disclose, inter alia, "the use of
fluorescent detectors to increase assay sensitivity in a membrane strip
device" (Ans. 17). Therefore, based on the combination of Polito, Kuo or
Maher, and Hudak, Examiner concludes that, at the time Appellants'
invention was made, it would have been prima facie obvious "to have
implemented europium, lanthanide fluorescent particles as detectable
particles, as taught by Hudak[], into the assay system as taught by Polito[]
and Kuo[] (or alternatively, the system of Polito[], Kuo[] and Maher[])"
(Id. at 18.) We are not persuaded.
Examiner failed to establish an evidentiary basis on this record to
support a conclusion that Hudak makes up for the foregoing deficiency of
Polito in combination with either of Kuo or Maher. As Appellants explain:
Nowhere does Hudak make any mention of a system including
a processor and memory resources that are configured to use a
ratio of signal detected from all or a portion of the second
population of particles to determine a time insensitive cut-off
value for the analyzer and determine the presence or absence of
analyte in the sample.
(Br. 13.)
CONCLUSION
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness.
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The rejection of claims 1 and 4--10 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Polito and Kuo is reversed.
The rejection of claims 1 and 4--10 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Polito, Kuo, and Maher is reversed.
The rejection of claims 11 and 12 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Polito, Kuo or Maher, and Hudak is
reversed.
Obviousness-type Double Patenting:
ISSUE
Should the obviousness-type double patenting rejection on this record
be summarily affirmed?
ANALYSIS
Appellants' claims 1 and 4--12 stand rejected under the judicially
created doctrine of obviousness-type double patenting as being unpatentable
over the claims of Egan in view of Polito (see Ans. 18-23; see also Final
Act. 20-24).
Appellants do not address the merits of this ground of rejection.
If a ground of rejection stated by Examiner is not addressed in
Appellants' Brief, Appellants waived any challenge to that ground of
rejection and that ground of rejection will be summarily sustained by the
Board. See 37 C.F.R. § 4I.37(c)(iv) ("[A]ny arguments or authorities not
included in the appeal brief will be refused consideration by the Board for
purposes of the present appeal."). Therefore, we summarily affirm the
nonstatutory obviousness-type double patenting rejection on this record.
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CONCLUSION
The rejection of Appellants' claims 1 and 4--12 under the judicially
created doctrine of obviousness-type double patenting as being unpatentable
over the claims of Egan in view of Polito is summarily affirmed.
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).
AFFIRMED
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