Huan-Ping Wu et al.

Patent Trials and Appeals Board

Aug 5, 2019

13053722 - (D) (P.T.A.B. Aug. 5, 2019)

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.
13/053,722 03/22/2011 Huan-Ping Wu 10DC003US02/47082-442US 8769
71331 7590 08/05/2019
NIXON PEABODY LLP
70 West Madison, Suite 3500
CHICAGO, IL 60602
EXAMINER
ZEMAN, MARY K
ART UNIT PAPER NUMBER
1631
NOTIFICATION DATE DELIVERY MODE
08/05/2019 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):
docketingchicago@nixonpeabody.com
ipairlink@nixonpeabody.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
_________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
_________________

Ex parte HUAN-PING WU, BERN HARRISON, and ERIC MAURER
_________________

Appeal 2018-001958
Application 13/053,722
Technology Center 1600
_________________

Before ERIC B. GRIMES, DEBORAH KATZ, and RYAN H. FLAX,
Administrative Patent Judges.

KATZ, Administrative Patent Judge.

DECISION ON APPEAL

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Appellants1 seek our review, under 35 U.S.C. § 134(a), of the
Examiner’s decision to reject claims 1, 6–9, 132, and 17–25. (App. Br. 1.)
We have jurisdiction under 35 U.S.C. § 6(b). An oral argument was held on
July 12, 2019.3 We REVERSE.
The Examiner rejected all of the claims as being drawn to ineligible
subject matter under 35 U.S.C. § 101. (See Final Office Action issued
January 30, 2017 (“Final Act.”) 2–9.)
Appellants do not argue for the separate patentability of the claims.
(See Appeal Brief 6.) Claim 1 is the only independent claim. We focus on
claim 1 in our review. See 37 C.F.R. § 41.37(c)(1)(iv).
Appellants’ claims are directed to methods of increasing the accuracy
of biosensor systems for determining the concentration of an analyte, such as
glucose, in a biological fluid sample. (See Specification (“Spec.”) abstract.)

1 Appellants report that the real party in interest is Ascensia Diabetes Care
Holdings AG. (App. Br. 3.)
2 Appellants refer to claims 1, 6–9, and 17–25 as the “appealed claims” in
the beginning of the Appeal Brief dated June 22, 2017 (see page 6), but
conclude that “the rejection of appeal claims 6, 6-9, 13, and 17-25 set forth
in the Office Action mailed January 30, 2017, should be reversed” (see page
29). Because the Reply Brief dated December 14, 2017, states that it “is
filed in support of the Appellants’ appeal . . . of the rejection of claims 1, 6-
9, 13, and 17-25 set forth in the Office Action mailed on January 30, 2017”
(page 1), we conclude that Appellants inadvertently omitted claim 13 from
reference to the “appeal claims” in the beginning of the Appeal Brief and
that Appellants appeal the rejection of all of the rejected claims.
3 The oral argument was held for both this appeal and appeal 2018-004941
of the rejection in application 14/231,874, which has the same real party-in-
interest and claims drawn to similar subject matter. Application 12/329,698
is also related to Appellants’ current application and was the subject of
appeal 2017-007857.
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The Specification explains that inaccuracies or errors in the determination of
analyte concentration may arise from “primary errors,” which are due to
conditions such as temperature and hematocrit, and from other “residual
errors.” (See id. ¶ 58.) The claimed methods compensate for these errors
using “primary functions” that determine error parameter values from
analysis of the analyte (see id. ¶ 70) and “residual functions” that determine
error parameter values from other sources, such as different behaviors or
processes (see id. ¶ 60). (See App. Br. 7–8.)
Appellants’ claim 1 recites:
A method of operating a biosensor system for determining an
analyte concentration in a biological fluid sample when at least one
operating condition error is introduced into an analysis by user self-
testing, the method comprising:
providing a biosensor system in the form of an analytical
instrument including
a measurement device having electrical circuitry
communicatively coupled to a processor, a storage medium, a signal
generator, and a sensor interface, the processor having instructions
and data stored in the storage medium, and
a test sensor having a base and a sample interface, the base
forming a reservoir and a channel with an opening, the base further
having a surface on which at least one working electrode and at least
one counter electrode are disposed, the reservoir being in electrical or
optical communication with the measurement device, the sample
interface having conductors connected to the working electrode and
the counter electrode;
determining in a controlled environment, prior to the user self-
testing, a primary error of an uncompensated analyte concentration,
the primary error being at least 50% of a total error of the
uncompensated analyte concentration and including at least one of a
temperature error or a hematocrit error; and
subsequently and outside the controlled environment, initiating
the user self-testing via the biosensor system to determine a
compensated analyte concentration, the user self-testing including:
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receiving the biological fluid sample in the opening, the
biological fluid sample flowing through the channel to fill at least in
part the reservoir of the test sensor,
introducing the operating condition error during the user self-
testing but prior to determining the compensated analyte concentration
in the biological fluid sample,
in response to receiving the biological fluid sample in the
reservoir, generating an input signal, by the processor, from the signal
generator,
transmitting the input signal by the sensor interface to the
sample interface for applying the input signal to the biological fluid
sample,
in response to the input signal and the uncompensated analyte
concentration, receiving and measuring, by the processor, an output
signal from the working electrode and the counter electrode of the test
sensor,
compensating, by the processor, the primary error in the output
signal with a primary function, the primary function being in the form
of an index function that is determined using error parameter values
from an analyte analysis or from a source independent of an analyte
responsive output signal,
compensating, by the processor, a remaining error of the total
error in the output signal with a first residual function, the first
residual function compensating the remaining error until errors
become random, the remaining error being the operating condition
error,
determining a compensated output signal based on the
compensating of the primary error and the remaining error in the
output signal, and
determining, by the processor, the compensated analyte
concentration in the biological fluid sample from the compensated
output signal in which the total error has been reduced by
compensating for the primary error and the remaining error.

(App. Br. 30–33.)
The Examiner rejected Appellants’ claims under 35 U.S.C. § 101,
relying on Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66
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(2012), and concluding that they are directed to the judicial exception of an
abstract idea, without adding significantly more. (See Ans. 2.) As
subsequently noted by the Supreme Court in Alice, Mayo set forth a
framework for determining subject matter eligibility, wherein
[f]irst, we determine whether the claims at issue are directed to
one of those patent-ineligible concepts . . . . If so, we then ask,
“[w]hat else is there in the claims before us?” . . . To answer
that question, we consider the elements of each claim both
individually and “as an ordered combination” to determine
whether the additional elements “transform the nature of the
claim” into a patent-eligible application.

Alice Corp. Pty. v. CLS Bank Int’l, 573 U.S. 208, 217 (2014) (quoting Mayo,
566 U.S. at 78). After determining that a claim is directed to a one of the
categories expressly provided in 35 U.S.C. § 101 (process, machine,
manufacture, or composition of matter), under the framework of Mayo we
are instructed to perform two steps. First, we are to determine whether the
claims are directed to a judicial exception (laws of nature, natural
phenomena, or abstract ideas). See Diamond v. Diehr, 450 U.S. 175, 185
(1981) (holding that “laws of nature, natural phenomena, and abstract ideas”
are not eligible subject matter). If so, we must undertake the second step
and ask whether there is anything additional that, when the claim is viewed
as a whole, adds significant elements beyond the sum of their parts taken
separately. See Mayo, 566 U.S. at 79–80.
After acknowledging that Appellants’ claims are directed to
processes, the Examiner undertook the first Mayo step and determined that
the claims recite the patent-ineligible concept of abstract ideas. (See Ans. 2–
3.) Specifically, the Examiner highlighted the following claim elements:
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“determining . . . a primary error of an uncompensated analyte
concentration . . . ,”

“initiating self-testing . . . to determine a compensated analyte
concentration,”

“generating an input signal . . . ,”

“transmitting the input signal . . . ,”

“receiving and measuring, by the processor, an output signal
. . . ,”

“compensating . . . the primary error. . . with a primary function
. . . ,”

“compensating . . . a remaining error of the total error . . . with a
first residual function . . . ,”

“determining a compensated output signal based on the
compensating of the primary error and the remaining error in the
output signal . . .” and

“determining . . . the compensated analyte concentration . . . in
which the total error has been reduced by compensating for the
primary error and the remaining error.”

(See id., quoting elements of claim 1.)
The Examiner determined that these recited steps are mathematical
manipulations of data, including applying the “primary function,” which is
an index function to remove at least 50% of a total error, and applying the
“first residual function,” which compensates for remaining error. (See Ans.
3.) In addition, the Examiner found that removing the primary and first
residual error from the signal that represents the compensated concentration
of the analyte is a mathematical manipulation of data. (See id.)
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The Examiner determined, further, that under the second part of the
Mayo analysis, the additional elements recited in claim 1 (a biosensor
system comprising a sensor interface, a processor, a signal generator, a
measurement device, a test sensor, electrodes and storage media) fail to rise
to the level of significantly more than the judicial exception because they
provide for only a generic biosensor system. (See Ans. 5.) The Examiner
cited references that were referenced in the Specification, relating to portable
measurement systems available from Bayer HealthCare and bench-top
systems available from CH Instruments, as evidence that the physical
elements of the recited biosensor systems are not additional elements that
render the abstract mathematical manipulations recited in claim 1 eligible.
(See Ans. 5–6, citing Spec. ¶¶ 3, 10, 13, 68, 72, and 139.)
The Examiner also found that
[a] bioinformatics problem like that of the claims (calculating errors in
sample analysis) is not “necessarily rooted in computer technology”
because the problem neither arises from, nor is caused by, the
computer technology itself. A bioinformatics problem exists
regardless of whether or not a computer also exists; the computer is
not necessary to the existence of a bioinformatics problem. Nor is the
computer necessary for the solution of the problem. It may be
impractical and tedious to analyze bioinformatics data without an
electronic computer, but it is not impossible.

(Ans. 7.)
In conclusion, the Examiner rejected Appellants’ claims after
determining that the limitations of the claims, individually, and in ordered
combination as a whole, do not rise to the level of significantly more than
the judicial exception of an abstract idea. (See Ans. 9.)
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When evaluating rejections under 35 U.S.C. § 101, we refer to the
revised guidance of the U.S. Patent and Trademark Office. See 2019
Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50–57
(2019) (“2019 Guidelines”). This guidance requires that after determining
that claimed subject matter falls within one of the four categories of
patentable subject matter identified in 35 U.S.C. § 101, a “revised step 2A”
is performed, which corresponds to the first step of the Alice/Mayo test
articulated above. Specifically, in a first prong of step 2A we determine
whether a claim recites at least one of the judicial exceptions of laws of
nature, natural phenomena, and abstract ideas. (See 2019 Guidelines, 84
Fed. Reg. 50, 53–54.) If a judicial exception is identified, a second prong of
step 2A requires a determination of whether the judicial exception is
integrated into a practical application. (See id.) If so, the claim is
determined to be directed to eligible subject matter under the 2019
Guidelines and the inquiry ends. (See id. at 54 (“When the exception is so
integrated [into a practical application], then the claim is not directed to a
judicial exception (Step 2A: NO) and is eligible. This concludes the
eligibility analysis.”).) If not, the analysis continues to “step 2B” to
determine if the claim provides an inventive concept. (See id. at 56.)
We agree with the Examiner that Appellants’ claim 1 is drawn to a
process and that it recites the judicial exception of abstract ideas.
Specifically, we agree with the Examiner that claim 1 recites mathematical
calculations at least in the limitations performed by the processor to
compensate the primary and remaining errors in the output signal with
primary and residual functions and to determine the compensated analyte
concentration in the biological fluid sample from the compensated output
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signal, wherein the total error has been reduced by compensating for the
primary error and the remaining error. (See Ans. 2–3.)
Under the 2019 Guidelines our next inquiry must be whether the
abstract ideas in claim 1 are integrated into a practical application. (See
2019 Guidelines 54–55.) The 2019 Guidelines provide examples of the
integration of judicial exceptions into practical applications, including when
the claim recites an additional element that integrates the judicial exception
in conjunction with a particular machine that is integral to the claim. (See
2019 Guidelines 55.)
Appellants’ claim 1 recites a biosensor system with an “analytical
instrument” and includes limitations for “receiving the biological fluid
sample in the opening [of a channel in the analytical instrument], the
biological fluid sample flowing through the channel to fill at least in part the
reservoir of the test sensor [of the analytical instrument]” in order to
generate an input signal that is the basis of the recited mathematical
calculations. (App. Br. 30–31.) Although, as the Examiner finds, the
system recited in claim 1 is a generic biosensor system, without physical
features that are unique from systems known in the art, the mathematical
calculations recited in claim 1 are used in conjunction with the particular
elements of the analytical instrument as an integral part of the claimed
method.
Appellants’ claims are drawn to determining analyte concentration,
specifically reducing the error in such determinations, in an apparently non-
conventional way after receiving input from the recited biosensor.
Appellants’ claims are limited to reducing errors in concentration
determinations using a biosensor and do not encompass reducing errors in
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any measurement with any machine. Thus, under the particular facts before
us, the abstract mathematical calculations recited in Appellants’ claims are
integrated into a practical application. Under the 2019 Guidelines, we
determine that Appellants’ claims are not directed to an abstract idea and,
therefore, are not directed to a judicial exception to an eligible process under
35 U.S.C. § 101. See Thales Visionix, Inc. v. United States, 850 F.3d 1343,
1348–49 (Fed. Cir. 2018) (holding that claims to system of tracking motion
with a mathematical calculation are drawn to eligible subject matter because
the system included a unique configuration of inertial sensors, which was
found to be “a non-conventional manner to reduce errors in measuring the
relative position and orientation of a moving object on a moving reference
frame.”); see also SiRF Tech., Inc. v. Int'l Trade Comm'n, 601 F.3d 1319,
1332–33 (Fed. Cir. 2010) (holding that claims to methods of calculating the
position of a GPS are drawn to eligible subject matter because a GPS
receiver is a machine that is integral to each of the claims at issue, even
though the GPS machine was not recited to have novel features).
Accordingly, we reverse the Examiner’s rejection in light of the 2019
Guidelines.
Conclusion
Upon consideration of the record and for the reasons given, the
rejection of claims 1, 6–9, 13, and 17–25 under 35 U.S.C. § 101 is not
sustained.
Therefore, we reverse the decision of the Examiner.

REVERSED