Matthias Koehler et al.

Patent Trials and Appeals Board

Aug 14, 2019

13606088 - (D) (P.T.A.B. Aug. 14, 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.
13/606,088 09/07/2012 Matthias Koehler ROQ 0036 NA/30593 US 7668
67491 7590 08/14/2019
DINSMORE & SHOHL, LLP
FIFTH THIRD CENTER
ONE SOUTH MAIN STREET
SUITE 1300
DAYTON, OH 45402
EXAMINER
MORGAN, ROBERT W
ART UNIT PAPER NUMBER
3626
NOTIFICATION DATE DELIVERY MODE
08/14/2019 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):
daytonipdocket@dinsmore.com
jackie.pike@roche.com
pair_roche@firsttofile.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________

Ex parte MATTHIAS KOEHLER, PETER BLASBERG,
and MARIUSZ TRACZ
____________________

Appeal 2018-002734
Application 13/606,0881
Technology Center 3600
____________________

Before JENNIFER S. BISK, LARRY J. HUME, and
JULIET MITCHELL DIRBA, Administrative Patent Judges.

HUME, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) of the Final
Rejection of claims 1–20, which are all claims pending in the application.
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 According to Appellants, the real party in interest is Roche Diabetes Care,
Inc. App. Br. 2.
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STATEMENT OF THE CASE2
The Invention
Appellants’ disclosed embodiments and claimed invention relate to
“technologies in the field of diabetes care, especially an analysis system for
performing an analysis of measured blood glucose values and a method for
using the analyzing system.” Spec. 1, ll. 10–12.
Representative Claims
Claims 1 and 10, reproduced below, are representative of the subject
matter on appeal (formatting added; emphases added to contested prior-art
limitations):
1. A system for analyzing measured blood glucose
values of a diabetic and providing statistical blood glucose level
information based on the measured blood glucose values, the
system comprising:
a display,
a memory device,
an application module comprising program instructions,
and
a processor connected to the display, the memory and the
application module, said program instructions which when
executed cause the processor to:
provide blood glucose measurement information which
comprises plurality of measured blood glucose values collected
within a measurement time frame,

2 Our decision relies upon Appellants’ Appeal Brief (“App. Br.,” filed
June 15, 2017); Reply Brief (“Reply Br.,” filed Jan. 16, 2018); Examiner’s
Answer (“Ans.,” mailed Nov. 14, 2017); Final Office Action (“Final Act.,”
mailed Sept. 23, 2016); and the original Specification (“Spec.,” filed
Sept. 7, 2012).
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perform a pre-analysis of the blood glucose measurement
information,
provide analysis data representing statistical blood
glucose level information for the plurality of measured blood
glucose values via an analysis performed by the processor with
the plurality of measured blood glucose values, and
provide as output of the system, output analysis data that
represents the analysis data on the display,
wherein the output analysis data comprises statistical
blood glucose level information which characterizes a whole set
of the measured blood glucose values collected in the
measurement time frame instead of discrete single blood
glucose values,
wherein the processor performs the analysis and/or
provides the output analysis data only if, in performance the
pre-analysis a fidelity check is positive for the measurement
time frame, in which the processor provides a positive result for
the fidelity check if the plurality of measured blood glucose
values comprises a set of measured blood glucose values being
representative for the measurement time frame such that the
statistical blood glucose level information, represented by the
analysis data and provided by the processor on the display as
the output analysis data, is only based on the measured blood
glucose values which have a positive fidelity check, and
wherein if the pre-analysis provides that the plurality of
measured blood glucose values is only representative for a time
period shorter than the measurement time frame, an adjusted
time frame which corresponds to the shorter time period
identified by the processor is then used by the processor as the
measurement time frame for the fidelity check such that the
statistical blood glucose level information based on the whole
set of the measured blood glucose values and displayed on the
display by the processor as the output analysis data is
representative only for the time period shorter than the
measurement time frame.
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10. A method improving statistical blood glucose level
information provided to a diabetic by a system performing an
analysis of measured blood glucose values from the diabetic,
the method comprising the steps of:
providing as input blood glucose measurement
information to a processor, the blood glucose measurement
information comprising a plurality of measured blood glucose
values collected within a measurement time frame,
performing a pre-analysis of the blood glucose
measurement information using the processor,
providing analysis data representing statistical blood
glucose level information which characterizes a whole set of the
measured blood glucose values collected in the measurement
time frame instead of discrete single blood glucose values by
performing an analysis of the plurality of measured blood
glucose values using the processor, and
providing as output from the processor output analysis
data representing the analysis data to a display,
wherein the step of performing an analysis of the
plurality of measured blood glucose values and/or the step of
providing the output analysis data are performed by the
processor only if, in the step of performing the pre-analysis a
fidelity check for the measurement time frame is positive, the
processor providing a positive result for the fidelity check if the
plurality of measured blood glucose values comprises a set of
measured blood glucose values being representative for the
measurement time frame such that the statistical blood glucose
level information, represented by the analysis data and provided
by the processor on the display as the output analysis data, is
only based on the measured blood glucose values which have a
positive fidelity check, and
wherein if the pre-analysis provides that the plurality of
measured blood glucose values is only representative for a time
period shorter than the measurement time frame, an adjusted
time frame which corresponds to the shorter time period
identified by the processor is then used by the processor as the
measurement time frame for the fidelity check such that the
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statistical blood glucose level information based on the whole
set of the measured blood glucose values and displayed on the
display by the processor as the output analysis data is
representative only for the time period shorter than the
measurement time frame.
Prior Art
The Examiner relies upon the following prior art as evidence in
rejecting the claims on appeal:
Kaufman et al. (“Kaufman”) US 2010/0174553 A1 July 8, 2010
Soni et al. (“Soni”) US 2011/0178820 A1 July 21, 2011
Rejections on Appeal
R1. Claims 1–20 stand rejected under 35 U.S.C. § 101 as being
directed to patent-ineligible subject matter. Final Act. 3.
R2. Claims 1–20 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over the combination of Kaufman and Soni. Final Act. 4.
CLAIM GROUPING
Based on Appellants’ arguments (App. Br. 7–26) and our discretion
under 37 C.F.R. § 41.37(c)(1)(iv), we decide the appeal of patent-ineligible
subject matter Rejection R1 of claims 1–20 on the basis of representative
method claim 10; we decide the appeal of obviousness Rejection R2 of
claims 1–9, 12–15 and 17–20 on the basis of representative system claim 1;
and we decide the appeal of obviousness Rejection R2 of claims 10 and 11
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on the basis of representative method claim 10. We address Rejection R2 of
separately argued claim 16, infra.3
ISSUES AND ANALYSIS
In reaching this decision, we consider all evidence presented and all
arguments actually made by Appellants. To the extent Appellants have not
advanced separate, substantive arguments for particular claims, or other
issues, such arguments are waived. 37 C.F.R. § 41.37(c)(1)(iv).
Based upon our review of the record, and the Revised Guidance
discussed herein, we find a preponderance of the evidence supports
particular arguments advanced by Appellants with respect to Rejection R1 of
claims 1–20 under § 101 for the specific reasons discussed below.
However, we disagree with Appellants’ arguments with respect to
Rejection R2 of claims 1–20 under 35 U.S.C. § 103(a) and, unless otherwise
noted, we incorporate by reference herein and adopt as our own: (1) the
findings and reasons set forth by the Examiner in the action from which this
appeal is taken, and (2) the reasons and rebuttals set forth in the Examiner’s
Answer in response to Appellants’ arguments.
We highlight and address specific findings and arguments regarding
claims 1, 10, and 16 for emphasis as follows.

3 “Notwithstanding any other provision of this paragraph, the failure of
appellant to separately argue claims which appellant has grouped together
shall constitute a waiver of any argument that the Board must consider the
patentability of any grouped claim separately.” 37 C.F.R. § 41.37(c)(1)(iv).
In addition, when Appellants do not separately argue the patentability of
dependent claims, the claims stand or fall with the claims from which they
depend. In re King, 801 F.2d 1324, 1325 (Fed. Cir. 1986).
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1. § 101 Rejection R1 of Claims 1–20
Issue 1
Appellants argue (App. Br. 7–19; Reply Br. 2–10) the Examiner’s
rejection of claim 1 under 35 U.S.C. § 101 as being directed to patent-
ineligible subject matter is in error. These contentions present us with the
following issue:
Under the USPTO’s Revised Guidance, informed by our governing
case law concerning 35 U.S.C. § 101, is claim 1 patent-ineligible under
§ 101?
Principles of Law
A. 35 U.S.C. § 101
“Eligibility under 35 U.S.C. § 101 is a question of law, based on
underlying facts.” SAP Am., Inc. v. InvestPic, LLC, 898 F.3d 1161, 1166
(Fed. Cir. 2018).
An invention is patent-eligible if it claims a “new and useful process,
machine, manufacture, or composition of matter.” 35 U.S.C. § 101.4
However, the Supreme Court has long interpreted 35 U.S.C. § 101 to include
implicit exceptions: “[l]aws of nature, natural phenomena, and abstract
ideas” are not patentable. Mayo Collaborative Servs. v. Prometheus Labs.,
Inc., 566 U.S. 66, 70 (2012) (brackets in original) (citing Diamond v. Diehr,
450 U.S. 175, 185 (1981)).

4 This threshold analysis of whether a claim is directed to one of the four
statutory categories of invention, i.e., a process, machine, manufacture, or
composition of matter, is referred to as “Step 1” in the USPTO’s patent-
eligibility analysis under § 101. MPEP § 2106.
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In determining whether a claim falls within an excluded category, we
are guided by the Supreme Court’s two-step framework, described in Mayo
and Alice. Alice Corp. v. CLS Bank Int’l, 573 U.S. 208, 217–18 (2014)
(citing Mayo, 566 U.S. at 75–77). In accordance with that framework, we
first determine what concept the claim is “directed to.” See Alice, 573 U.S.
at 219 (“On their face, the claims before us are drawn to the concept of
intermediated settlement, i.e., the use of a third party to mitigate settlement
risk.”); see also Bilski v. Kappos, 561 U.S. 593, 611 (2010) (“Claims 1 and 4
in petitioners’ application explain the basic concept of hedging, or protecting
against risk . . . .”).
Concepts determined to be abstract ideas, and thus patent ineligible,
include certain methods of organizing human activity, such as fundamental
economic practices (Alice, 573 U.S. at 219–20; Bilski, 561 U.S. at 611);
mathematical formulas (Parker v. Flook, 437 U.S. 584, 594–95 (1978)); and
mental processes (Gottschalk v. Benson, 409 U.S. 63, 67 (1972)). Concepts
determined to be patent eligible include physical and chemical processes,
such as “molding rubber products” (Diehr, 450 U.S. at 191); “tanning,
dyeing, making water-proof cloth, vulcanizing India rubber, smelting ores”
(id. at 182 n.7 (quoting Corning v. Burden, 56 U.S. 252, 267–68 (1854)));
and manufacturing flour (Benson, 409 U.S. at 69 (citing Cochrane v.
Deener, 94 U.S. 780, 785 (1876))).
In Diehr, the claim at issue recited a mathematical formula, but the
Supreme Court held “[a] claim drawn to subject matter otherwise statutory
does not become nonstatutory simply because it uses a mathematical
formula.” Diehr, 450 U.S. at 187; see also id. at 191 (“We view
respondents’ claims as nothing more than a process for molding rubber
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products and not as an attempt to patent a mathematical formula.”). Having
said that, the Supreme Court also indicated that a claim “seeking patent
protection for that formula in the abstract . . . is not accorded the protection
of our patent laws, and this principle cannot be circumvented by attempting
to limit the use of the formula to a particular technological environment.”
Id. (citation omitted) (citing Benson and Flook); see, e.g., id. at 187 (“It is
now commonplace that an application of a law of nature or mathematical
formula to a known structure or process may well be deserving of patent
protection.”).
Abstract ideas may include, but are not limited to, fundamental
economic practices, methods of organizing human activities, and
mathematical formulas or relationships. Alice, 573 U.S. at 217–21. Under
this guidance, we must therefore ensure at step one that we articulate what
the claims are directed to with enough specificity to ensure the step one
inquiry is meaningful. Id. at 217 (“[W]e tread carefully in construing this
exclusionary principle lest it swallow all of patent law.”).
If the claim is “directed to” an abstract idea, we turn to the second
step of the Alice and Mayo framework, where “we must examine the
elements of the claim to determine whether it contains an ‘“inventive
concept”’ sufficient to ‘transform’ the claimed abstract idea into a patent-
eligible application.” Alice, 573 U.S. at 221 (citation omitted). “A claim
that recites an abstract idea must include ‘additional features’ to ensure ‘that
the [claim] is more than a drafting effort designed to monopolize the
[abstract idea].’” Id. (alterations in original) (quoting Mayo, 566 U.S. at 77).
“[M]erely requir[ing] generic computer implementation[] fail[s] to transform
that abstract idea into a patent-eligible invention.” Id.
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B. USPTO Revised Guidance
The PTO recently published revised guidance in the Federal Register
concerning the application of § 101. 2019 Revised Patent Subject Matter
Eligibility Guidance, 84 Fed. Reg. 50 (January 7, 2019) (hereinafter
“Revised Guidance”) (https://www.govinfo.gov/content/pkg/FR-2019-01-
07/pdf/2018-28282.pdf).
Under the Revised 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 human activity such as a fundamental economic
practice, or mental processes);5 and
(2) additional elements that integrate the judicial
exception into a practical application (see Manual for Patent
Examining Procedure (“MPEP”) §§ 2106.05(a)–(c), (e)–(h)).6
See Revised Guidance 52–53.
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 is not “well-understood, routine, conventional”
in the field (see MPEP § 2106.05(d)); or

5 Referred to as “Revised Step 2A, Prong 1” in the Revised Guidance
(hereinafter “Step 2A(i)”).
6 Referred to as “Revised Step 2A, Prong 2” in the Revised Guidance
(hereinafter “Step 2A(ii)”).
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(4) simply appends well-understood, routine,
conventional activities previously known to the industry,
specified at a high level of generality, to the judicial exception.7
See Revised Guidance 56.
Step 2A(i) – Abstract Idea
Informed by our judicial precedent, the Revised Guidance extracts and
synthesizes key concepts identified by the courts as abstract ideas to explain
that the abstract idea exception includes the following groupings of subject
matter, when recited as such in a claim limitation:
(a) Mathematical concepts—mathematical relationships,
mathematical formulas or equations, mathematical calculations;
(b) Certain methods of organizing human activity —
fundamental economic principles or practices (including
hedging, insurance, mitigating risk); commercial or legal
interactions (including agreements in the form of contracts;
legal obligations; advertising, marketing or sales activities or
behaviors; business relations); managing personal behavior or
relationships or interactions between people (including social
activities, teaching, and following rules or instructions); and
(c) Mental processes—concepts performed in the human
mind (including an observation, evaluation, judgment, opinion).
Under the Revised Guidance, if the claim does not recite a judicial
exception (a law of nature, natural phenomenon, or subject matter within the
enumerated groupings of abstract ideas above), then the claim is patent-

7 Items (3) and (4) continue to be collectively referred to as “Step 2B” of the
Supreme Court’s two-step framework, described in Mayo and Alice.
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eligible at Step 2A(i). This determination concludes the eligibility analysis,
except in situations identified in the Revised Guidance.8
However, if the claim recites a judicial exception (i.e., an abstract idea
enumerated above, a law of nature, or a natural phenomenon), the claim
requires further analysis for a practical application of the judicial exception
in Step 2A(ii).
Step 2A(ii) – Practical Application
If a claim recites a judicial exception in Step 2A(i), we determine
whether the recited judicial exception is integrated into a practical
application of that exception in Step 2A(ii) by: (a) identifying whether there
are any additional elements recited in the claim beyond the judicial
exception(s); and (b) evaluating those additional elements individually and
in combination to determine whether they integrate the exception into a
practical application.
The seven identified “practical application” sections of the MPEP,9
cited in the Revised Guidance under Step 2A(ii), are:

8 In the rare circumstance in which an examiner believes a claim limitation
that does not fall within the enumerated groupings of abstract ideas should
nonetheless be treated as reciting an abstract idea, the procedure described in
of the Guidance for analyzing the claim should be followed. See Revised
Guidance, Section III.C.
9 See MPEP §§ 2106.05(a)–(c), (e)–(h). Citations to the MPEP herein refer
to revision [R-08.2017]. Sections 2106.05(a), (b), (c), and (e) are indicative
of integration into a practical application, while §§ 2106.05(f), (g), and (h)
relate to limitations that are not indicative of integration into a practical
application.
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(1) MPEP § 2106.05(a) Improvements to the Functioning of
a Computer or To Any Other Technology or Technical
Field
(2) MPEP § 2106.05(b) Particular Machine
(3) MPEP § 2106.05(c) Particular Transformation
(4) MPEP § 2106.05(e) Other Meaningful Limitations
(5) MPEP § 2106.05(f) Mere Instructions To Apply An
Exception
(6) MPEP § 2106.05(g) Insignificant Extra-Solution Activity
(7) MPEP § 2106.05(h) Field of Use and Technological
Environment
See Revised Guidance 55.
If the recited judicial exception is integrated into a practical
application as determined under one or more of the MPEP sections cited
above, then the claim is not directed to the judicial exception, and the patent-
eligibility inquiry ends. See Revised Guidance 54. If not, then analysis
proceeds to Step 2B.
Step 2B – “Inventive Concept” or “Significantly More”
Under our reviewing courts’ precedent, it is possible that a claim that
does not “integrate” a recited judicial exception under Step 2A(ii) is
nonetheless patent eligible. For example, the claim may recite additional
elements that render the claim patent eligible even though a judicial
exception is recited in a separate claim element.10 The Federal Circuit has
held claims eligible at the second step of the Alice/Mayo test (USPTO Step
2B) because the additional elements recited in the claims provided
“significantly more” than the recited judicial exception (e.g., because the

10 See, e.g., Diehr, 450 U.S. at 187.
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additional elements were unconventional in combination).11 Therefore, if a
claim has been determined to be directed to a judicial exception under
Revised Step 2A, we must also evaluate the additional elements individually
and in combination under Step 2B to determine whether they provide an
inventive concept (i.e., whether the additional elements amount to
significantly more than the exception itself).12
Under the Revised Guidance, we must consider in Step 2B whether an
additional element or combination of elements: (1) “Adds a specific
limitation or combination of limitations that are not well-understood,
routine, conventional activity in the field, which is indicative that an
inventive concept may be present;” or (2) “simply appends well-understood,
routine, conventional activities previously known to the industry, specified
at a high level of generality, to the judicial exception, which is indicative
that an inventive concept may not be present.” See Revised Guidance,
III.B.13

11 See, e.g., Amdocs (Israel), Ltd. v. Openet Telecom, Inc., 841 F.3d 1288,
1300, 1304 (Fed. Cir. 2016); BASCOM Global Internet Services, Inc. v.
AT&T Mobility LLC, 827 F.3d 1341, 1349–52 (Fed. Cir. 2016); DDR
Holdings v. Hotels.com, L.P., 773 F.3d 1245, 1257–59 (Fed. Cir. 2014).
12 The patent eligibility inquiry may contain underlying issues of fact.
Mortg. Grader, Inc. v. First Choice Loan Servs. Inc., 811 F.3d 1314, 1325
(Fed. Cir. 2016). In particular, “[t]he question of whether a claim element or
combination of elements is well-understood, routine and conventional to a
skilled artisan in the relevant field is a question of fact.” Berkheimer v. HP
Inc., 881 F.3d 1360, 1368 (Fed. Cir. 2018).
13 In accordance with existing Step 2B guidance, an Examiner’s finding that
an additional element (or combination of elements) is well understood,
routine, conventional activity must be supported with at least one of the four
specific types of evidence required by the USPTO Berkheimer
Memorandum, as shown above. For more information concerning evaluation
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In the Step 2B analysis, an additional element (or combination of
elements) is not well-understood, routine or conventional unless the
examiner finds an evidentiary basis, and expressly supports a rejection in
writing with, one or more of the following:
1. A citation to an express statement in the
specification or to a statement made by an applicant during
prosecution that demonstrates the well-understood, routine,
conventional nature of the additional element(s). . . .
2. A citation to one or more of the court decisions
discussed in MPEP § 2106.05(d)(II) as noting the well-
understood, routine, conventional nature of the additional
element(s).
3. A citation to a publication that demonstrates the
well-understood, routine, conventional nature of the additional
element(s). . . .
4. A statement that the examiner is taking official
notice of the well-understood, routine, conventional nature of
the additional element(s). . . .
See Berkheimer Memo.
The analysis in Step 2B further determines whether an additional
element or combination of elements:
(a) Adds a specific limitation or combination of
limitations that are not well-understood, routine, conventional
activity in the field, which is indicative that an inventive
concept may be present; or

of well-understood, routine, conventional activity, see MPEP § 2106.05(d),
as modified by the USPTO Berkheimer Memorandum (USPTO
Commissioner for Patents Memorandum dated Apr. 19, 2018, “Changes in
Examination Procedure Pertaining to Subject Matter Eligibility, Recent
Subject Matter Eligibility Decision (Berkheimer v. HP, Inc.)” (hereinafter
“Berkheimer Memo”).
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(b) simply appends well-understood, routine,
conventional activities previously known to the industry,
specified at a high level of generality, to the judicial exception,
which is indicative that an inventive concept may not be
present.
Revised Guidance, and see Berkheimer Memo.
If the Examiner or the Board determines under Step 2B that the
element (or combination of elements) amounts to significantly more than the
exception itself, the claim is eligible, thereby concluding the eligibility
analysis.
However, if a determination is made that the element and combination
of elements does not amount to significantly more than the exception itself,
the claim is ineligible under Step 2B, and the claim should be rejected for
lack of subject matter eligibility.
Analysis
Based upon our de novo review of the record in light of recent
Director Policy Guidance with respect to patent-eligible subject matter
rejections under 35 U.S.C. § 101, we reverse the rejection of claims 1–20 for
the specific reasons discussed below.
Step 1: Statutory Category
Claim 10, as a method (process) claim, recites one of the enumerated
categories of eligible subject matter in 35 U.S.C. § 101. Therefore, the issue
before us is whether the claim is directed to a judicial exception without
significantly more.
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Step 2A(i): Does the Claim Recite a Judicial Exception?
The Examiner determined claim 10 is directed to “the abstract idea of
comparing new and stored information and using rules to identify options
. . . [where] the abstract idea . . . is described, for example, by the providing,
performing, providing and providing steps.” See Final Act. 3; Ans. 3.
We find claim 10 does not recite the judicial exceptions of either
natural phenomena or laws of nature. We evaluate, de novo, whether
claim 1 recites an abstract idea based upon the Revised Guidance.
Claim 10 recites “[a] method improving statistical blood glucose level
information provided to a diabetic by a system performing an analysis of
measured blood glucose values from the diabetic,” wherein the method
includes the steps of:
(1) “[P]roviding as input blood glucose measurement
information to a processor, the blood glucose measurement
information comprising a plurality of measured blood glucose
values collected within a measurement time frame.”
(2) “[P]erforming a pre-analysis of the blood glucose
measurement information using the processor.”
(3) “[P]roviding analysis data representing statistical
blood glucose level information which characterizes a whole set
of the measured blood glucose values collected in the
measurement time frame instead of discrete single blood
glucose values by performing an analysis of the plurality of
measured blood glucose values using the processor, and
(4) “[P]roviding as output from the processor output
analysis data representing the analysis data to a display.”
(5) “[T]he step of performing an analysis of the plurality
of measured blood glucose values and/or the step of providing
the output analysis data are performed by the processor only if,
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in the step of performing the pre-analysis a fidelity check for
the measurement time frame is positive.”
(6) “[T]he processor providing a positive result for the
fidelity check if the plurality of measured blood glucose values
comprises a set of measured blood glucose values being
representative for the measurement time frame such that the
statistical blood glucose level information, represented by the
analysis data and provided by the processor on the display as
the output analysis data, is only based on the measured blood
glucose values which have a positive fidelity check.”
(7) . . . “[I]f the pre-analysis provides that the plurality of
measured blood glucose values is only representative for a time
period shorter than the measurement time frame, an adjusted
time frame which corresponds to the shorter time period
identified by the processor is then used by the processor as the
measurement time frame for the fidelity check such that the
statistical blood glucose level information based on the whole
set of the measured blood glucose values and displayed on the
display by the processor as the output analysis data is
representative only for the time period shorter than the
measurement time frame.”
Claims App’x.
The Specification provides context as to what the claimed invention is
directed to. In this case, the Specification discloses the invention “relates
generally to technologies in the field of diabetes care, especially an analysis
system for performing an analysis of measured blood glucose values and a
method for using the analyzing system.” Spec. 1.
Appellants’ Abstract provides additional description of the invention:
A system and method for analyzing measured blood
glucose values is disclosed, wherein the system includes a
display device, a memory device, and a processor having
program instructions which when executed cause the processor
to provide blood glucose measurement information including a
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plurality of measured blood glucose values collected within a
measurement time frame, perform a pre-analysis of the blood
glucose measurement information, provide analysis data
representing statistical blood glucose level information for the
plurality of measured blood glucose values by performing an
analysis of the plurality of measured blood glucose values, and
provide output analysis data representing the analysis data,
wherein the provision of analysis data and / or the provision of
output analysis data are performed if, in the step of performing
the pre-analysis, at least one of the following control checks is
positive a fidelity check, and an adherence check.
Spec. 18.
Under the broadest reasonable interpretation standard,14 we conclude
claim 10 recites steps that would ordinarily occur when measuring and
analyzing blood glucose information to determine relevant statistics related
thereto. See Final Act. 3; Ans. 3. For example, step (2) performing pre-
analysis of blood glucose information by ensuring the fidelity of prior
collected information, would be a common step in any statistical blood
glucose level analysis to ensure the validity of measurement data. Also, step
(3), providing results of the blood glucose level analysis, logically would be
expected to occur after testing. Limitation (5) would also be expected to be
carried out to ensure data validity, i.e., “performing an analysis of the

14 During prosecution, claims must be given their broadest reasonable
interpretation when reading claim language in light of the specification as it
would be interpreted by one of ordinary skill in the art. In re Am. Acad. of
Sci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004). Under this standard,
we interpret claim terms using “the broadest reasonable meaning of the
words in their ordinary usage as they would be understood by one of
ordinary skill in the art, taking into account whatever enlightenment by way
of definitions or otherwise that may be afforded by the written description
contained in the applicant’s specification.” In re Morris, 127 F.3d 1048,
1054 (Fed. Cir. 1997).
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plurality of measured blood glucose values” ensures the measurement time
frame is valid, by checking whether “a fidelity check for the measurement
time frame is positive.”
Thus, under Step 2A(i), we generally agree with the Examiner that
claim 10 recites an abstract idea. However, we differ in the characterization,
and particularly conclude claim 1 recites a mental processes. Specifically,
claim 1 recites a concept that can be performed in the human mind, i.e., an
observation, evaluation, judgment, and/or opinion, which we further note
may be performed without a computer using pen and paper. This type of
activity, i.e., statistical analysis of blood glucose level information over a
measurement period, includes longstanding conduct that existed well before
the advent of computers and the Internet, and could be carried out by a
human with pen and paper. See CyberSource Corp. v. Retail Decisions, Inc.,
654 F.3d 1366, 1375 (Fed. Cir. 2011).15

15 Our reviewing court recognizes that “[a]n abstract idea can generally be
described at different levels of abstraction.” Apple, Inc. v. Ameranth, Inc.,
842 F.3d 1229, 1240 (Fed. Cir. 2016). That need not and, in this case does
not, “impact the patentability analysis.” Id. at 1241. Further, “[t]he Board’s
slight revision of its abstract idea analysis does not impact the patentability
analysis.” Id. Moreover, merely combining several abstract ideas does not
render the combination any less abstract. RecogniCorp, LLC v. Nintendo
Co., 855 F.3d 1322, 1327 (Fed. Cir. 2017) (“Adding one abstract idea (math)
to another abstract idea . . . does not render the claim non-abstract.”); see
also FairWarning IP, LLC v. Iatric Sys., Inc., 839 F.3d 1089, 1093–94 (Fed.
Cir. 2016) (determining the pending claims were directed to a combination
of abstract ideas).
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We conclude claim 10, under our Revised Guidance, recites a judicial
exception of mental processes, i.e., a concept performed in the human mind,
and thus an abstract idea.
Step 2A(ii): Judicial Exception Integrated into a Practical Application?
If the claims recite a patent-ineligible concept, as we conclude above,
we proceed to the “practical application” Step 2A(ii) in which we determine
whether the recited judicial exception is integrated into a practical
application of that exception by: (a) identifying whether there are any
additional elements recited in the claim beyond the judicial exception(s); and
(b) evaluating those additional elements individually and in combination to
determine whether they integrate the exception into a practical application.
In addition to the abstract steps recited in limitations (2), (3), and (5)
identified in Step 2A(i), supra, claim 10 further recites limitations
(1) “providing as input blood glucose measurement information to a
processor” and limitation (4) “providing as output from the processor output
analysis data representing the analysis data to a display.”
As to the specific limitations, we find limitation (1) recites
insignificant data gathering. See MPEP § 2106.05(g). Data gathering, as
performed by the steps or function in Appellants’ claims, is a classic
example of insignificant extra-solution activity. See, e.g., In re Bilski, 545
F.3d 943, 963 (Fed. Cir. 2008) (en banc), aff’d sub nom, Bilski v. Kappas,
561 U.S. 593 (2010).
We also find limitation (4) recites insignificant post solution activity.
The Supreme Court guides that the “prohibition against patenting abstract
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ideas ‘cannot be circumvented’ [by] adding ‘insignificant postsolution
activity.’” Bilski, 561 U.S. at 610–11 (quoting Diehr, 450 U.S. at 191–92).
However, for the reasons discussed below, we conclude conditional
limitations (6) (“providing a positive result for the fidelity check if the
plurality of measured blood glucose values comprises a set of measured
blood glucose values being representative for the measurement time frame”)
and (7) (“the plurality of measured blood glucose values is only
representative for a time period shorter than the measurement time frame, an
adjusted time frame which corresponds to the shorter time period identified
by the processor is then used by the processor as the measurement time
frame for the fidelity check”) integrate the abstract idea into a practical
application as determined under at least one of the cited MPEP sections.16
For example, with respect to Figure 2, Appellants’ Specification
discloses:
If . . . the fidelity check . . . provides a successful result,
analysis data representing statistical blood glucose level
information for the plurality of measured blood glucose values
is provided by performing a structured analysis of the plurality
of measured blood glucose values (step 24). In step 25, output
analysis data representing the analysis data derived before are
provided for outputting to the user, for example via the display
2 of the analyzing device 1.
Spec. 7.
Along these lines, Appellants argue:

16 See, e.g., MPEP § 2106.05(a) “Improvements to the Functioning of a
Computer or To Any Other Technology or Technical Field,” and
§ 2106.05(e) “Other Meaningful Limitations.”
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[T]he application . . . describes a fidelity check step
during the pre-analysis step to assess whether a set of data is
representative of a measurement time frame such that sufficient
statistical data is used in the analysis step to avoid analysis of
insufficient data that may lead to medical misinterpretation,
which bolsters a conclusion that the present claims are directed
to an improvement in blood glucose analysis technology to
improve the statistical blood glucose level information provided
to a diabetic by a system performing an analysis of measured
blood glucose values from the diabetic after performing a pre-
analysis including a positive fidelity check such that a processor
is provided with sufficient statistical data for improved
processing and improved output results.
App. Br. 11.
We find Appellants’ argument persuasive that carrying out steps (6)
and (7), conditioned upon successful data fidelity checks relating to a
determination that measurement time frames are representative, provide
improvements to the underlying technology or technical field, namely,
statistical glucose level monitoring and analysis systems. See MPEP
§ 2106.05(a) or, alternatively, § 2106.05(e) “Other Meaningful Limitations.”
With respect to these other meaningful limitations, we find guidance
in MPEP § 2106.05(e), which summarizes and relies upon our reviewing
court’s holdings in Diehr, cited supra, and Classen Immunotherapies, Inc. v.
Biogen IDEC, 659 F.3d 1057 (Fed. Cir. 2011) (decision on remand from the
Supreme Court, which had vacated the lower court’s prior holding of
ineligibility in view of Bilski).
In Diehr, the Court evaluated the additional non-abstract limitations,
and found them to be meaningful, because they sufficiently limited the use
of the (abstract idea) mathematical equation to the practical application of
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molding rubber products. MPEP § 2106.05(e) (citing Diehr, 450 U.S.
at 184, 187).
In Classen, the Court held that, although the analysis step was an
abstract mental process that collected and compared known information, the
(practical application) immunization step was meaningful because it
integrated the results of the analysis into a specific and tangible method that
resulted in the method “moving from abstract scientific principle to specific
application.” MPEP § 2106.05(e) (citing Classen, 659 F.3d at 1066–68).
We find these other meaningful limitations identified above provide a
technological improvement to statistical glucose level analysis methods and
systems. App. Br. 11. Accordingly, we conclude, when the claim is
considered as a whole, the recited judicial exception is integrated into a
practical application as determined under either MPEP sections 2106.06(a)
or 2106.05(e) cited above, such that the claim is patent-eligible.
Because the claims are directed to a patent-eligible concept, this
concludes the patent-eligibility inquiry.
Therefore, based upon the findings and legal conclusions above, on
this record and in consideration of the Revised Guidance, we are persuaded
the claims are directed to patent-eligible subject matter, such that we do not
sustain the § 101 rejection of claim 10, and grouped claims 1–9 and 11–20
which stand therewith. See Claim Grouping, supra.

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2. § 103 Rejection R2 of Claims 1–9, 12–15 and 17–20
Issue 2
Appellants argue (App. Br. 19–26; Reply Br. 10–16) the Examiner’s
rejection of independent system claim 1 under 35 U.S.C. § 103(a) as being
obvious over the combination of Kaufman and Soni is in error. These
contentions present us with the following issue:
Did the Examiner err in finding the cited prior art combination teaches
or suggests “[a] system for analyzing measured blood glucose values of a
diabetic and providing statistical blood glucose level information based on
the measured blood glucose values,” that includes, inter alia, “an application
module comprising program instructions, and a processor connected to the
display, the memory and the application module,” wherein
if the pre-analysis provides that the plurality of measured
blood glucose values is only representative for a time
period shorter than the measurement time frame, an
adjusted time frame which corresponds to the shorter
time period identified by the processor is then used by the
processor as the measurement time frame for the fidelity
check such that the statistical blood glucose level
information based on the whole set of the measured
blood glucose values and displayed on the display by the
processor as the output analysis data is representative
only for the time period shorter than the measurement
time frame,
as recited in claim 1 (emphasis added)?
Analysis
Appellants contend the Examiner’s reliance upon Soni is mistaken
because “none of the cited portions of Soni actually do teach or describe the
recitations of the entire last two paragraphs of claims 1 and 10, let alone at
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least the recitation of an automatically adjusted time frame in claims 1
and 10 to represent sufficient statistical blood glucose level information.”
App. Br. 21. Appellants thereby conclude “the Examiner has not actually set
forth or explained how any of the cited portions of Soni are actually
supposed to teach at least such an automatically adjusted time frame as
recited in claims 1 and 10 but has merely set forth citations to paragraphs
from Soni without clearly articulating any reasoning as to how the cited
portion teach the claim recitations of claims 1 and 10.” Id.
In response, the Examiner determined “the concept included in the
limitations regarding ‘an adjusted time frame’ is merely a reference to only
performing calculations on data that is actually acquired during a certain
(i.e., shorter) time frame which is a well-understood caveat of performing
data analysis . . . . and an ‘adjustment’ is made when performing analysis on
data such that missing data or information does not improperly skew the
analysis and/or calculations.” Ans. 24.
Appellants argue that the Examiner’s explanation does not clearly
articulate “reasoning how any of the cited portions of Soni are actually
supposed to teach at least such an automatically adjusted time frame,” but
instead “appears to take improper official notice that such a feature is a well-
understood caveat of performing data analysis.” Reply Br. 12 (citing
Ans. 24).
Appellants’ arguments do not persuade us of Examiner error. We
agree with the Examiner that Soni discloses performing structured data
collection that is automatically scheduled to occur “upon one or more entry
criteria being met at some unknown time” and ends automatically “upon one
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or more exit criteria being met at some unknown time.” Soni Abstract,
¶¶ 10–11. Soni also discloses that an analysis of collected data may result in
the rejection of certain data and that accepted data can be “defined by time-
related . . . events.” Id. ¶¶ 49, 51. Finally, Soni notes that “a sampling
group determination can be made as to which information has to be
collected,” for example, “the sampling group can be . . . time based which
can use a target time (e.g, used for an alerting feature), a lower time window
bound, an upper time window bound, etc.” Id. ¶ 91.
We agree with the Examiner’s finding that a person of ordinary skill
in the art would have understood these disclosures of Soni to disclose the
recited “adjusted time frame” and would have found it obvious to make such
modification to Kaufman’s system. Here, Appellants “present[] no evidence
that the [Examiner's proposed modification] was uniquely challenging or
difficult for one of ordinary skill in the art.” Leapfrog Enters., Inc. v.
Fisher-Price, Inc., 485 F.3d 1157, 1162 (Fed. Cir. 2007). Appellants further
allege, “nothing in Soni appears to reasonably disclose or suggest such a
fidelity check, let alone a fidelity check as a pre-analysis requirement prior
to analysis and/or output of analysis data.” App. Br. 22.
With respect to Appellants’ lack of a “fidelity check” argument
quoted above, the Examiner finds Kaufman in view of Soni teaches or
suggests a “data-parsing layer that is responsible for validating the integrity
of device data received.” Ans. 25 (citing Kaufman ¶ 41). We agree with the
Examiner’s finding that Kaufman’s teaching or suggestion of a “fidelity
check” (of data) reads on Kaufman’s data integrity validation, as cited by the
Examiner.
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Appellants also submitted a declaration under 37 C.F.R. § 1.132 by
inventor Matthias Koehler (hereinafter, “Declaration”) that purports to
provide an understanding from the perspective of one skilled in the art that
the combined teachings of Kaufman in view of Soni is deficient with respect
to providing a teaching or suggestion of the contested limitations of claim 1.
The Examiner provides a response indicating the Declaration merely
proffers the opinion of the inventor, and does not provide evidentiary facts
concerning how a person with skill in the art would interpret the reference
combination. The Examiner makes additional findings with respect to the
probative value of the Declaration. See Ans. 26. We agree with the
Examiner’s evidentiary findings.
Therefore, based upon the findings and legal conclusions above, on
this record, we are not persuaded of error in the Examiner’s reliance on the
cited prior art combination to teach or suggest the disputed limitation of
claim 1, nor do we find error in the Examiner’s resulting legal conclusion of
obviousness. Therefore, we sustain the Examiner’s obviousness rejection of
independent claim 1, and grouped claims 2–9, 12–15 and 17–20, which fall
therewith. See Claim Grouping, supra.

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3. § 103 Rejection R2 of Claims 10 and 11
Issue 3
Appellants argue (App. Br. 19–26; Reply Br. 10–16) the Examiner’s
rejection of independent method claim 10 under 35 U.S.C. § 103(a) as being
obvious over the combination of Kaufman and Soni is in error. These
contentions present us with the following issue:
Did the Examiner err in finding the cited prior art combination teaches
or suggests “[a] method improving statistical blood glucose level
information provided to a diabetic by a system performing an analysis of
measured blood glucose values from the diabetic,” that includes the step of
“performing a pre-analysis of the blood glucose measurement information
using the processor,” wherein, inter alia,
if the pre-analysis provides that the plurality of measured
blood glucose values is only representative for a time
period shorter than the measurement time frame, an
adjusted time frame which corresponds to the shorter
time period identified by the processor is then used by
the processor as the measurement time frame for the
fidelity check such that the statistical blood glucose level
information based on the whole set of the measured
blood glucose values and displayed on the display by the
processor as the output analysis data is representative
only for the time period shorter than the measurement
time frame,
as recited in claim 10?
Analysis
Appellants do not distinguish their arguments concerning independent
method claim 10 from independent system claim 1, as set forth above in our
analysis of Issue 2. Particularly, Appellants assert the Examiner’s reliance
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upon Soni is misplaced because “none of the cited portions of Soni actually
do teach or describe the recitations of the entire last two paragraphs of
claims 1 and 10, let alone at least the recitation of an automatically adjusted
time frame in claims 1 and 10 to represent sufficient statistical blood glucose
level information.” App. Br. 21. Appellants further allege, “nothing in Soni
appears to reasonably disclose or suggest such a fidelity check, let alone a
fidelity check as a pre-analysis requirement prior to analysis and/or output of
analysis data.” App. Br. 22.
In reply to Appellants’ contentions, the Examiner states:
[T]he concept included in the limitations regarding “an
adjusted time frame” is merely a reference to only
performing calculations on data that is actually acquired
during a certain (i.e., shorter) time frame which is a
well-understood caveat of performing data analysis. That
is to say, one cannot perform analysis on data one does
not have and an “adjustment” is made when performing
analysis on data such that missing data or information
does not improperly skew the analysis and/or
calculations. As such, Kaufman in view of Soni more
than seemingly suggests the limitation regarding “output
of the system” and “an adjusted time frame”, as recited
by the Applicant.
Ans. 24 (emphasis added).
In reply to the Examiner, Appellants argue:
Rather than clearly articulating how Kaufman and/or
Soni expressly discloses or impliedly suggests at least the
“adjusted time frame” feature of claims 1 and 10 as
required to establish prima facie obviousness, the
Examiner appears to take improper official notice that
such a feature is a well-understood caveat of performing
data analysis.
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Reply Br. 12.
We note the contested limitation of claim 10 conditionally recites, in
pertinent part, “if the pre-analysis provides that the plurality of measured
blood glucose values is only representative for a time period shorter than the
measurement time frame, an adjusted time frame which corresponds to the
shorter time period identified by the processor is then used by the processor
as the measurement time frame.” Claim App’x (emphasis added).
As a matter of claim construction, we conclude the contested method
step limitation is conditional, i.e., if the stated condition does not occur, then
the adjusted time frame is not used by the processor. That is to say, the
stated condition makes the rest of the limitation conditional on the pre-
analysis determining that a shorter time frame is needed. Therefore, under
the broadest reasonable interpretation standard,17 the shorter time frame is
not needed if the pre-analysis provides that the plurality of measured glucose
values is representative for a measurement time frame. As the Examiner
determined, “one cannot perform analysis on data one does not have.”
Ans. 24.
Further, as an additional matter of claim construction in accord with
our precedential holding in Schulhauser, the Examiner need not “present
evidence of the obviousness of the remaining method steps . . . that are not
required to be performed under a broadest reasonable interpretation of the
claim.” Ex parte Schulhauser, Appeal No. 2013-007847, at *9 (PTAB,
April 28, 2016) (precedential) (holding “The Examiner did not need to
present evidence of the obviousness of the remaining method steps of

17 See In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d at 1364.
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claim 1 that are not required to be performed under a broadest reasonable
interpretation of the claim (e.g., instances in which the electrocardiac signal
data is not within the threshold electrocardiac criteria such that the condition
precedent for the determining step and the remaining steps of claim 1 has not
been met.”)); see also Ex parte Katz, Appeal No. 2010-006083, 2011
WL 514314, at *4–5 (BPAI Jan. 27, 2011).18
We, therefore, agree under Schulhauser with the Examiner’s
determination that if the pre-analysis provides that the plurality of measured
glucose values is representative for a measurement time frame, the shorter
time frame is not needed. Thus, “if the pre-analysis provides that the
plurality of measured blood glucose values is only representative for a time
period shorter than the measurement time frame” limitation of claim 10 is a
conditional step that, under Schulhauser, the Examiner need not present
evidence that teaches or suggests the conditional limitation.
Accordingly, based upon the findings and legal conclusions above, on
this record, we are not persuaded of error in the Examiner’s reliance on the
cited prior art combination to teach or suggest the disputed limitation of
claim 10, nor do we find error in the Examiner’s resulting legal conclusion
of obviousness. Therefore, we sustain the Examiner’s obviousness rejection

18 See, also e.g., Applera Corp. v. Illumina, Inc., 375 Fed. Appx. 12, 21
(Fed. Cir. 2010) (unpublished) (affirming a district court's interpretation of a
method claim as including a step that need not be practiced if the condition
for practicing the step is not met); Cybersettle, Inc. v. Nat’l Arbitration
Forum, Inc., 243 Fed. Appx. 603, 607 (Fed. Cir. 2007) (unpublished) (“It is
of course true that method steps may be contingent. If the condition for
performing a contingent step is not satisfied, the performance recited by the
step need not be carried out in order for the claimed method to be
performed.”).
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of independent claim 10, and grouped claim 11, which falls therewith. See
Claim Grouping, supra.
4. § 103 Rejection R2 of Claim 16
Appellants raised additional arguments for patentability of dependent
claim 16, rejected on the same basis as claim 1 (App. Br. 23; Reply
Br. 14–15); however, we find that the Examiner has rebutted each of those
arguments in the Answer by a preponderance of the evidence. Final Act. 12;
Ans. 25–26.
The Examiner found, “providing a different ‘color code’ that is
indicative of the statistical parameters falling in or out of a given target limit
is arguably an ‘arrangement or style’ . . . . [as recited such that] Kaufman in
view of Soni more than seemingly suggest ‘wherein each of the statistical
parameters are displayed together with a color code.’” Ans. 25.
We find Appellants have not demonstrated that the Examiner’s
proffered combination of references relied upon to teach or suggest
including a color code as a particular “arrangement or style” would have
been “uniquely challenging or difficult for one of ordinary skill in the art.”
See Leapfrog Enters., Inc. v. Fisher-Price, Inc., 485 F.3d 1157, 1162 (Fed.
Cir. 2007) (citing KSR Int'l Co. v. Teleflex, Inc., 550 U.S. 398, 418 (2007)).
Nor have Appellants provided objective evidence of secondary
considerations which our reviewing court guides “operates as a beneficial
check on hindsight.” Cheese Sys., Inc. v. Tetra Pak Cheese and Powder
Sys., 725 F.3d 1341, 1352 (Fed. Cir. 2013).
Therefore, we adopt the Examiner’s findings and underlying
reasoning, which we incorporate herein by reference. Consequently, based
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upon the findings above, on this record, we are not persuaded of error in the
Examiner’s reliance on the cited prior art combination to teach or suggest
the disputed limitations of claim 16, nor do we find error in the Examiner’s
resulting legal conclusion of obviousness.
REPLY BRIEF
To the extent Appellants may advance new arguments in the Reply
Brief (Reply Br. 2–16) not in response to a shift in the Examiner’s position
in the Answer, arguments raised in a Reply Brief that were not raised in the
Appeal Brief or are not responsive to arguments raised in the Examiner’s
Answer will not be considered except for good cause (see 37 C.F.R.
§ 41.41(b)(2)), which Appellants have not shown.
CONCLUSIONS
(1) Under our Revised Guidance, governed by relevant case law,
we conclude claims 1–20 are patent-eligible under 35 U.S.C. § 101, and we
do not sustain Rejection R1.
(2) The Examiner did not err with respect to obviousness Rejection
R2 of claims 1–20 under 35 U.S.C. § 103(a) over the cited prior art
combination of record, and we sustain the rejection.
Because we have affirmed at least one ground of rejection with
respect to each claim on appeal, we affirm the Examiner’s decision. See 37
C.F.R. § 41.50(a)(1).

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DECISION
We affirm the Examiner’s decision rejecting claims 1–20.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv). See 37
C.F.R. § 41.50(f).
AFFIRMED