Ex Parte Callicoat et al

Patent Trials and Appeals Board

Apr 19, 2019

13552542 - (D) (P.T.A.B. Apr. 19, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/552,542 07/18/2012
20995 7590 04/23/2019
KNOBBE MARTENS OLSON & BEAR LLP
2040 MAIN STREET
FOURTEENTH FLOOR
IRVINE, CA 92614
FIRST NAMED INVENTOR
David N. Callicoat
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.
OPTIS.267A 1933
EXAMINER
NEGIN, RUSSELL SCOTT
ART UNIT PAPER NUMBER
1631
NOTIFICATION DATE DELIVERY MODE
04/23/2019 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):
j ayna.cartee@knobbe.com
efiling@knobbe.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DAVID N. CALLICOAT and MONNETT H. SOLDO
Appeal 2018-001105
Application 13/552,542
Technology Center 1600
Before JEFFREY N. FREDMAN, RYAN H. FLAX, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1,2 under 35 U.S.C. § 134 involving claims to an
analyte detection system. The Examiner rejected the claims as directed to
patent-ineligible subject matter. We have jurisdiction under 35 U.S.C.
§ 6(b ). We reverse.
1 Appellants identify the Real Party in Interest as OptiScan Biomedical
Corporation (see App. Br. 4).
2 We have considered and refer to the Specification of July 18, 2012
("Spec."); Final Office Action ofNov. 14, 2016 ("Final Act."); Appeal Brief
of July 13, 2017 ("App. Br."); Examiner's Answer of Sept. 15, 2017
("Ans."); and Reply Brief of Nov. 13, 2017 ("Reply Br.").
Appeal 2018-001105
Application 13/552,542
Statement of the Case
Background
"It is advantageous to measure the levels of certain analytes, such as
glucose, in a bodily fluid, such as blood" (Spec. ,r 3). The Specification
explains that, when analyzing the analyte data, the analysis may involve a
"calibration set usable to estimate an analyte concentration for a sample"
(Spec. ,r 5). The calibration data may be useful where, for example, "the
calibration coefficient is determined so as to have reduced or minimal
sensitivity to the presence of the identified Library Interferents" (Spec.
,r 184) where the interferents "may cause analyte estimation to be subject to
errors" (Spec. ,r 217). The result of the calibration may, for example,
"provide a good match between the estimated glucose concentration and the
measured glucose concentration" in patients with diabetes (see Spec. ,r 221 ).
The Claims
Claims 40-49 and 51---60 are on appeal. 3 Independent claim 40 is
representative and reads as follows:
40. An analyte detection system comprising:
a fluidic system configured to withdraw a fluid sample
from a fluid source and direct the withdrawn sample to a
sample container;
a sensor system configured to interface with the sample
held in the sample container to obtain a measurement of an
analyte in the sample;
a hardware processor system configured to execute stored
program instructions such that the analyte detection system:
accesses one or more calibration sets each usable
to estimate a concentration of the analyte in the sample;
3 We note that claim 50 was cancelled in the amendment filed October 6,
2016.
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Application 13/552,542
accesses the obtained measurement of the analyte
in the sample;
determines, for each of the one or more calibration
sets, whether the calibration set is eligible to estimate
concentration of the analyte from the measurement of the
sample by:
and
calculating a respective reconstructed
measurement of the analyte in the sample based on
the calibration set;
obtaining a metric based on a comparison of
the reconstructed measurement of the analyte to
the obtained measurement; and
comparing the obtained metric to a
prediction eligibility threshold;
determines an estimated concentration of the
analyte in the sample based at least in part on the
obtained measurement of the analyte in the sample and
the calibration sets determined to be eligible; and
a display device configured to (i) display the estimated
concentration if at least one of the one or more calibration sets
is determined to be eligible to estimate concentration of the
analyte or (ii) provide notification if none of the one or more
calibration sets is determined to be eligible to estimate
concentration of the analyte.
The Rejection
The Examiner rejected claims 40-49 and 51---60 under 35 U.S.C.
§ 101 as directed to an abstract idea (Final Act. 2--4).
The Examiner finds that the claims are directed to the "abstract idea of
reconstructing a respective reconstructed measurement of the analyte in the
sample based on the calibration set" (Final Act. 3). The Examiner further
finds the "mathematical relationships are analogous to the Arrhenius
equation in Diamond v. Diehr, 450 U.S. 175, (1981), which was also found
to be abstract" (Final Act. 3).
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Application 13/552,542
Appellants argue that the asserted abstract ideas are not directed to a
judicial exception, "[ r ]ather, they are integrated into the claim and provide
the physical structures for obtaining the analyte and the sample . . . . The
claim also specifies a physical structure for displaying the results and
providing notifications (a display device)" (App. Br. 15-16).
The Alice Test
To determine whether a claim is invalid under § 101, we employ the
two-step Alice framework. In Alice step one, we ask whether the claims are
directed to a patent ineligible concept, such as an abstract idea or law of
nature. Alice Corp. v. CLS Bankint'l, 573 U.S. 208, 217-18 (2014).
Although system claims are generally eligible subject matter, claims that are
directed only to abstract ideas and/ or natural phenomena are directed to
patent ineligible concepts. Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788
F.3d 1371, 1376 (Fed. Cir. 2015). In Alice step two, we examine the
elements of the claims to determine whether they contain an inventive
concept sufficient to transform the claimed judicial exception into a patent-
eligible application. Mayo Collaborative Servs. v. Prometheus Labs., Inc.,
566 U.S. 66, 71-72 (2012) (quoting Alice, 573 U.S. at 217-18).
2019 Guidance
The PTO recently published revised guidance on the application of
§ 101. USPTO, 2019 Revised Patent Subject Matter Eligibility Guidance,
84 Fed. Reg. 50-57 (2019) ("2019 Guidelines"). Under that guidance, we
first look to whether the claim recites:
(1) any judicial exceptions, including certain groupings of abstract
ideas (i.e., mathematical concepts, certain methods of organizing
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Application 13/552,542
human activity such as a fundamental economic practice, or mental
processes); and
(2) additional elements that integrate the judicial exception into a
practical application (see MPEP § 2106.05(a}-(c), (e}-(h)).
See 2019 Guidelines, 84 Fed. Reg. 54--55. Only if a claim (1) recites a
judicial exception and (2) does not integrate that exception into a practical
application, do we then look to whether the claim:
(3) adds a specific limitation beyond the judicial exception that are not
"well-understood, routine, conventional" in the field (see MPEP
§ 2106.05(d)); or
(4) simply appends well-understood, routine, conventional activities
previously known to the industry, specified at a high level of
generality, to the judicial exception.
See 2019 Guidelines, 84 Fed. Reg. 51.
Analysis
Applying Alice step one, we look to see if the claim recites any
judicial exceptions. First, we find the claim recites an apparatus that uses a
predictive model based on a mathematical concept, specifically, a calibration
set or sets, the calibration being a mathematical operation designed to
improve accuracy in determining an estimated analyte concentration based
on analyte measurements. As described by the Specification, "the estimated
analyte concentration is calculated according to a linear formula ... and
calibration coefficients may represent arrays of numbers, the multiplication
operation indicated in the preceding formula may comprise a sum of the
products of the measurements and coefficients" (Spec. ,r 184). The
Specification further cites to prior art examples of calibration methods
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Application 13/552,542
including "'An Enhanced Algorithm for Linear Multivariate Calibration,' by
Andrew J. Berger, et al., Analytical Chemistry, Vol. 70, No. 3, February 1,
1998, pp. 623-627" (Spec. ,r 196). Therefore, we determine that the claim
recites a mathematical concept in the abstract idea category of judicial
exceptions.
Second, we find that claim 40 recites a system for collecting and
analyzing data, specifically analyte data, using fluidic and sensor systems,
and then analyzing the data with a processor and displaying the result of the
analysis. As explained by our reviewing court, "analyzing information by
steps people go through in their minds, or by mathematical algorithms,
without more, [are treated] as essentially mental processes within the
abstract-idea category." Elec. Power Grp., LLC v. Alstom S.A., 830 F.3d
1350, 1354 (Fed. Cir. 2016). Because claim 40 recites collection and
analyzing information by mathematical algorithms, we find claim 40 recites
a mental process in the abstract idea category of judicial exceptions.
A claim that recites a judicial exception requires further analysis to
determine if any additional elements integrate the judicial exception into a
practical application. See 2019 Guidelines, 84 Fed. Reg. 54. The 2019
Guidelines explain that additional elements that integrate the judicial
exception into a practical application include applying the judicial exception
in some meaningful way beyond generally linking the use of the judicial
exception to a particular technological environment. See 2019 Guidelines,
84 Fed. Reg. 55 ( citing Diehr, 450 U.S. at 184). For example, the claims in
Diehr recited a method for operating a rubber-molding press including the
step of "opening the press automatically when a said comparison [ of
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Application 13/552,542
calculated cure time vs. elapsed time] indicates equivalence." See Diehr,
450 U.S. 179 n.5.
While this is a very close case, when we apply the Diehr reasoning
consistent with the 2019 Guidelines, we find that claim 40 at issue recites a
practical application of
a display device configured to (i) display the estimated
concentration if at least one of the one or more calibration sets
is determined to be eligible to estimate concentration of the
analyte or (ii) provide notification if none of the one or more
calibration sets is determined to be eligible to estimate
concentration of the analyte.
We determine that this step of claim 40 integrates the judicial exceptions
into the practical application of analyte detection. This integration occurs
because of the requirement for a choice of displaying either an estimated
concentration based on a calibration set or displaying a null result if no
calibration set. Specifically, the claimed system with alternative
configurations of the display device is analogous to the Diehr step of
opening the press because both require a specific, practical physical act in a
particular technological environment that extends the methods beyond
mental steps or mathematical analysis. In the instant case, this configuration
informs the artisan as to whether the analyte concentration can or cannot be
displayed, imposing a real world check on whether an analyte concentration
can be provided to the end user or if the analyte concentration cannot be
provided due to the absence of calibration. Because we conclude that the
judicial exceptions recited in claim 40 are integrated into the practical
application of analyte detection systems, we conclude that claim 40 is
directed to patent-eligible subject matter.
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We agree with Appellants, not the Examiner, that In re TL! Commc 'ns
LLC Patent Litig., 823 F.3d 607, 610 (Fed. Cir. 2016) does not mandate a
different result. In TL!, the claimed method for recording and administering
digital images did not integrate the data analysis into a real world solution
but rather simply stored the data on a server. TL! Commc 'ns, 823 F.3d at
610. TL! identified this storage as "a well-established 'basic concept"' that
was "not directed to a solution to a 'technological problem."' TL!
Commc 'ns, 823 F.3d at 613. We conclude that the instant claim 40, even if
based on a judicial exception, is integrated into a technological problem of
determining whether a concentration measured by an analyte detection
system should be reported to the user or not.
We also find these facts similar to those in McRO, Inc. v. Bandai
Namco Games Am. Inc., 837 F.3d 1299 (Fed. Cir. 2016). In McRO, the
method integrated specific process steps of phoneme analysis to obtain facial
expression control of animated characters, thereby integrating the
improvement into the animation process. See McRO, 837 F.3d at 1315.
Similarly here, the instant methods integrates a specific determination of
estimated analyte concentrations that are eligible to be reported to an end
user, thereby integrating the improvement into an analyte detection system.
Alice Step Two
We are persuaded by the Appellants' position that the Examiner does
not establish sufficiently that the claims on appeal are unpatentable based on
Alice step one. As such, we need not proceed to Alice step two in order to
conclude that, on the record before us, it has not been established
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Application 13/552,542
sufficiently that the claims on appeal fail the Alice Test for patent eligibility.
Conclusion of Law
We conclude that claims 40-49 and 51-60 are not directed to patent-
ineligible subject matter.
SUMMARY
In summary, we reverse the rejection of claims 40-49 and 51-60
under 35 U.S.C. § 101.
REVERSED
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