SHIRASUNA, Kei et al.

Patent Trials and Appeals Board

Sep 24, 2019

14508522 - (D) (P.T.A.B. Sep. 24, 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.
14/508,522 10/07/2014 Kei SHIRASUNA 11333/719 8638
757 7590 09/24/2019
BGL
P.O. BOX 10395
CHICAGO, IL 60610
EXAMINER
PAPCIAK, SHARON M
ART UNIT PAPER NUMBER
1651
MAIL DATE DELIVERY MODE
09/24/2019 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte KEI SHIRASUNA, RYUICHIRO EBI, and SHIGEKI ABE
____________

Appeal 2019-003798
Application 14/508,522
Technology Center 1600
____________

Before RICHARD M. LEBOVITZ, GEORGIANNA W. BRADEN, and
DAVID COTTA, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL
The claims in this appeal are directed to a cell analysis method and
cell analyzer to evaluate the pathology of epithelial tissues. The Examiner
rejected the claims under 35 U.S.C. § 101 as reciting patent ineligible
subject matter. Pursuant to 35 U.S.C. § 134, Appellant1 appeals the
Examiner’s determination that the claims are unpatentable. We have
jurisdiction for the appeal under 35 U.S.C. § 6(b).
We AFFIRM.

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies the real party in interest as Sysmex
Corporation. Appeal Br. 2 (entered Nov. 20, 2018).
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STATEMENT OF THE CASE
The Examiner determined that claims 1, 2, 4–12, 14, 16–19 and 21 are
directed to a judicial exception to patent eligibility and consequently rejected
the claims under 35 U.S.C. § 101. Ans. 4. The Examiner designated the
rejection as a new ground of rejection based on newly citing the United
States Patent & Trademark Office’s (USPTO) recently published revised
guidance on the application of 35 U.S.C. § 101. USPTO’s January 7, 2019
Memorandum, 2019 Revised Patent Subject Matter Eligibility Guidance, 84
Fed. Reg. 50, 51–57 (2019) (“2019 Eligibility Guidance”).
There are two independent claims on appeal, claims 1 and 14.
Claim 1 is a method claim and claim 14 is directed to an apparatus, a cell
analyzer. Both claims comprise the same steps which, when accomplished,
result in “an indication of the presence of cancer suspected cells in the
epithelial tissues.” We select claim 1 as representative. Claim 1 reads as
follows (bracketed letters [a]-[g] have been added for reference to the steps
in the claim):
1. A cell analysis method comprising:
[a] receiving, by a communication interface, cell
parameters of a respective sample cell collected from epithelial
tissues, wherein the cell parameters include at least a first
parameter representing a cell size (C) and a second parameter
representing a cell nucleus size (N), wherein the sample cells
are analyzed by a measurement apparatus using a cytometer to
obtain the cell parameters;
[b] calculating, by a CPU, a N/C ratio of a respective
sample cell based on the first and second parameters, wherein
the N/C ratio represents a relative size of a nucleus in a sample
cell with respect to the cell size (C) of the sample cell, and the
N/C ratio becomes large when the relative size of a nucleus in a
sample cell becomes large;
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[c] applying, by the CPU, a first threshold (V11) to the
N/C ratio of a respective sample cell to identify target cells in
the sample cells having N/C ratios equal to or higher than the
first threshold (V11) and non-target cells in the sample cells
having N/C ratios lower than the first threshold (V11), wherein
the target cells have nucleuses, relative sizes thereof being
larger than relative sizes of nucleuses of the non-target cells in
relation to sizes of their cytoplasm, and comprise parabasal
cells in the epithelial tissues, which are more valuable for
pathology of the epithelial tissues than the non-target cells;
[d] counting, by the CPU, a number (N1) of the target
cells and a number (N2) of the nontarget cells;
[e] classifying, by the CPU, the target cells into at least a
first group of cells and a second group of cells according to
their amounts of DNA, wherein the cells in the first group each
have a greater amount of DNA than the cells in the second
group;
[f1] counting, by the CPU, a number (N3) of the first
group of cells and a number (N4) of the second group of cells
and [f2] calculating a ratio (N3/N4) of the number (N3) of the
first group of cells to the number (N4) of the second group; and
[g] [g1] applying, by the CPU, a second threshold (s4) to
the ratio (N3/N4) to evaluate pathology of the epithelial tissues
such that an evaluation result provides an indication of the
presence of cancer suspected cells in the epithelial tissues when
the ratio (N3/N4) is equal to or larger than the second threshold
(s4), [g2] wherein the second threshold (s4) is varied, by the
CPU, according to a proportion of the target cells in the
collected sample cells, wherein the proportion is calculated
based on the number (N1) of the target cells and the number
(N2) of the non-target cells.

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SECTION 101 REJECTION
The Examiner rejected all of the pending claims under 35 U.S.C. §
101 as directed to a judicial exception to patent eligibility. Ans. 3. The
Examiner found that the claims are directed to an abstract idea and law of
nature. Ans. 4–6.

Principles of Law
Under 35 U.S.C. § 101, an invention is patent-eligible if it claims a
“new and useful process, machine, manufacture, or composition of matter.”
Not every discovery is eligible for patent protection, however. Diamond v.
Diehr, 450 U.S. 175, 185 (1981). “Excluded from such patent protection are
laws of nature, natural phenomena, and abstract ideas.” Id. The Supreme
Court articulated a two-step analysis to determine whether a claim falls
within an excluded category of invention. Alice Corp. Pty. Ltd. v. CLS Bank
Int’l, 573 U.S. 208, 216 (2014); Mayo Collaborative Servs. v. Prometheus
Labs, Inc., 566 U.S. 66, 75–77 (2012).
In the first step, it is determined “whether the claims at issue are
directed to one of those patent-ineligible concepts.” Alice, 573 U.S. at 217.
If it is determined that the claims are directed to an ineligible concept, then
the second step of the two-part analysis is applied in which it is asked
“‘[w]hat else is there in the claims before us?’” Id. The Court explained
that this step involves
a search for an “ ‘inventive concept’ ” – i.e., an element or
combination of elements that is “sufficient to ensure that the
patent in practice amounts to significantly more than a patent
upon the [ineligible concept] itself.”
Alice, 573 U.S. at 217–18 (citing from Mayo, 566 U.S. at 75–77).
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Alice, relying on the analysis in Mayo of a claim directed to a law of
nature, stated that in the second part of the analysis “the elements of each
claim both individually and ‘as an ordered combination’” must be
considered “to determine whether the additional elements ‘transform the
nature of the claim’ into a patent-eligible application.” Alice, 573 U.S.
at 217.
The USPTO published revised guidance on the application of 35
U.S.C. § 101. USPTO’s January 7, 2019 Memorandum, 2019 Revised
Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50, 51–57 (2019)
(“2019 Eligibility Guidance”). This guidance provides direction on how to
implement the two-part analysis of Mayo and Alice.
Step 2A, Prong One, of the 2019 Guidelines, looks at the specific
limitations in the claim to determine whether the claim recites a judicial
exception to patent eligibility. In Step 2A, Prong Two, the claims are
examined to identify whether there are additional elements in the claims that
integrate the exception in a practical application, namely, is there a
“meaningful limit on the judicial exception, such that the claim is more than
a drafting effort designed to monopolize the judicial exception.” 84 Fed.
Reg. 54 (2. Prong Two).
If the exception is not integrated into a practical application, then as in
the Mayo/Alice framework, Step 2B of the 2019 Guidelines asks whether
there is an inventive concept to ensure that the patent is significantly more
than a patent on the ineligible concept, itself. 84 Fed. Reg. 56. In making
this determination, it must be considered whether there are specific
limitations or elements recited in the claim “that are not well-understood,
routine, conventional activity in the field, which is indicative that an
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inventive concept may be present” or whether the claim “simply appends
well-understood, routine, conventional activities previously known to the
industry, specified at a high level of generality, to the judicial exception,
indicative that an inventive concept may not be present.” 84 Fed. Reg. 56
(footnote omitted).
With these guiding principles, we proceed to determine whether the
claimed subject matter in this appeal is eligible for patent protection under
35 U.S.C. § 101. As explained in more detail below, we conclude that the
claims are directed to patent-ineligible subject matter.

Step 2A, Prong One
In Step 2A, Prong One, of the 2019 Guidelines, the specific
limitations in the claim are examined to determine whether the claim recites
a judicial exception to patent eligibility, namely whether the claim recites an
abstract idea, law of nature, or natural phenomenon. The 2019 Guidelines
list three groupings of abstract ideas, two of which the Examiner found to be
recited in claims 1 and 14 (Ans. 6): “(a) Mathematical concepts—
mathematical relationships, mathematical formulas or equations,
mathematical calculations” and “(c) Mental processes--concepts performed
in the human mind (including an observation, evaluation, judgment,
opinion).” 84 Fed. Reg. 52.
The first step of the claim, step [a], comprises “receiving” cell
parameters “wherein the sample cells are analyzed by a measurement
apparatus using a cytometer to obtain the cell parameters.” This step of
receiving cell parameter measurements from a cytometer does not fall within
any of the three groupings identified in the 2019 Guidelines as reciting an
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abstract idea. It also does not recite a law of nature.
Step [b] of claim 1 calculates the ratio between nucleus size and cell
size (“N/C”) based on parameters obtained from a cytometer (“calculating,
by a CPU, a N/C ratio”). Because “N/C” is a mathematical formula, we find
that it constitutes a mathematical concept and abstract idea under the 2019
Guidelines.
Step [c] of the claim comprises applying a threshold to the N/C ratio
calculated in step [b] to determine target cells and non-target cells. The
application of a threshold to a calculated ratio, a value, is act that can be
performed in the human mind and therefore falls in the mental concept
grouping.
In step [d], the number of target cells (N1) and non-target cells (N2)
determined in step [c] are counted. Counting cells is a mental process
because it can be performed in the human mind.
Step [e] of the claim comprises classifying the target cells into two
groups based on their amounts of DNA. Classifying cells based on a value
is a mental act that can be performed in the human mind and therefore is
mental process as that grouping is described in the 2019 Guidelines.
The number of cells in each group classified in step [e] are counted in
step [f1], where the first group is N3 and the second group is N4. Counting
is a mental process, as found for step [d], because it can be performed in the
human mind.
In step [f2], a ratio for N3/N4 is calculated. Because “N3/N4” is a
mathematical formula, we find that it constitutes a mathematical concept and
abstract idea.
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Step [g1] applies a second threshold to the ratio N3/N4 calculated in
step [f2]. As we concluded for step [c], we find the application of a
threshold to a calculated ratio to be an act that can be performed in the
human mind and therefore a mental concept
Step [g2] comprises “wherein the second threshold (s4) is varied, by
the CPU, according to a proportion of the target cells in the collected sample
cells, wherein the proportion is calculated based on the number (N1) of the
target cells and the number (N2) of the non-target cells.” The threshold s4 is
varied based on the proportion of N1 and N2 cells, which Appellant
describes in the Appeal Brief as the N1/N2 ratio. Appeal Br. 8. The
limitation does not disclose a formula by which the threshold is varied.
However, changing the threshold can be performed in the human mind
because an evaluation is made regarding how much to adjust the threshold
based on the N1/N2 ratio. For example, the Specification discloses:
When the ratio N1/N2 is smaller than the threshold s2 (S109:
YES), the CPU 301 sets Vsh1 as a threshold s4 (S110). When
the ratio N1/N2 is greater than or equal to the threshold s2
(S109: NO), the CPU 301 sets as the threshold s4 Vsh2 which
is smaller than Vsh1 (S111). The threshold s4 is a value to be
used in determination of canceration (S116) in the latter stage.
Spec. ¶ 93. Accordingly, we find that step [g2] also falls into the mental
concept grouping.
In sum, we conclude the Examiner did not err in finding that claim 1
recites judicial exceptions to patent eligibility under 35 U.S.C. ¶ 101.
We, thus, proceed to Step 2A, Prong Two, to determine whether these
exceptions are integrated into a practical and patent-eligible application.

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Step 2A, Prong Two
Prong Two of Step 2A under the 2019 Guidance asks whether there
are additional elements that integrate the exception into a practical
application. As in the Mayo/Alice framework, we must look at the claim
elements individually and “as an ordered combination” to determine whether
the additional elements integrate the recited abstract idea into a practical
application.
As explained above, limitations [b] through [g] of claim 1 recite
judicial exceptions to patent eligibility. Specifically, each of these steps
individually perform either a mathematical concept or mental process in
which the cell parameters obtained from a cytometer are operated on to
result in “an indication of the presence of cancer suspected cells in the
epithelial tissues.” The steps calculate an N/C ratio [b], apply a threshold to
the ratio to determine target and non-target cells [c], count the target and
non-target cells [d], classify the target cells into two groups based on DNA
[e], count the cells in each group [f1], calculate a ratio N3/N4 between the
two groups, apply a second threshold to the N3/N4 ratio [g1], and vary the
second threshold based on the N1/N2 ratio [g2].2 The only step in the claim

2 Clam 1 can be distinguished from Example 39 of the 2019 Subject Matter
Eligibility Examples: Abstract Ideas (Jan. 7, 2019) (“2019 EE”) that use a
“neural network,” a type of machine learning that is based on mathematical
concepts. Although the claim in Example 39 recites a “neural network,” it
does so generically without specifically reciting any steps that include
mathematical concepts or mental processes. As discussed above, rejected
claim 1 in this appeal recites the mental processes and mathematical
concepts used to perform the claimed process, and these steps are asserted to
be an improvement. Example 39, on the other hand, is not asserted to be an
improvement of the neural network.

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that does not recite an abstract idea is step [a] in which a cytometer is used
to obtain cell parameter data, comprising cell size and nucleus size.
In order to find a practical application, the judicial exceptions must be
integrated into additional elements in the claim. The only additional element
recited in the claim is step [a]. Step [a] of claim 1 recites “receiving . . . cell
parameters of a respective sample cell collected from epithelial tissues, . . .
wherein the sample cells are analyzed by a measurement apparatus using a
cytometer to obtain the cell parameters.” The cytometer therefore performs
the analysis of the cells “to obtain the cell parameters.” The abstract ideas
[b]–[g] recited in the claim are not integrated into the performance of the
cytometer in obtaining measurements of the cell parameters, but rather are
accomplished after the cytometer completes its measurement of the cell size
and cell nucleus. As in Parker v. Flook, 437 U.S. 584 (1978), the claim is
directed to the abstract ideas recited in steps [b]–[g], and not to the process
of using the cell cytometer – the only additional element recited in claim 1.
In Flook, a claim reciting a mathematical concept was found to be
ineligible for patent, despite providing “a new and presumably better method
for calculating alarm limit values.” Flook, 437 U.S. at X. The claim was
directed to a “method for updating the value of at least one alarm limit on at
least one process variable involved in a process comprising the catalytic
chemical conversion of hydrocarbons.” Flook, 437 U.S. at 596–97
(Appendix to Opinion). The recited steps in the Flook claim comprised
determining a new alarm base using a mathematical algorithm, using the
alarm base to update an alarm limit, and then adjusting the alarm limit to the
updated value. Id. The Court found the claim to be a judicial exception to
subject matter ineligibility, holding that “[t]he process itself, not merely the
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mathematical algorithm, must be new and useful.” Id. at 591.
In this case, the improvement described by Appellant is in the abstract
idea recited in [b]–[f] of claim 1, and not an improvement to the cytometer
recited in [a] of the claims. While we recognize that the “indication of the
presence of cancer suspected cells in the epithelial tissues” is improved, the
solution to this problem of detecting cancers is asserted by Appellant to the
mathematical operations and mental processes utilized to discern whether a
cell is cancerous, which are judicial exceptions to patent eligibility.
The claims in this appeal are distinguishable from the claims in
Diamond v. Diehr, 450 U.S. 175 (1981), in which the claims were directed
to a method of operating a rubber-molding press to mold a compound by
curing it in a mold cavity. Application of Diehr, 602 F.2d 982, 983–84
(CCPA 1979). The temperature in the mold during the rubber-molding
process was constantly determined and provided to a digital computer. Id.
The computer calculated the Arrhenius equation for the reaction time during
the cure to determine when the compound was cured and to automatically
open the press. Id. Although the claim recited a mathematical algorithm,
the Arrhenius equation, the Court held that the claim was eligible for a
patent.
[W]hen a claim containing a mathematical formula implements
or applies that formula in a structure or process which, when
considered as a whole, is performing a function which the
patent laws were designed to protect (e.g., transforming or
reducing an article to a different state or thing), then the claim
satisfies the requirements of § 101.

Diehr, 450 U.S. at 192–93.
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In this case, while the steps in the rejected claim instruct how to
determine an indication of cancer, the abstract idea embodied in these steps
does not change how the cytometer operates. This is in contrast to Diehr,
where the mathematical formula recited in the claim informed when to open
the mold to obtain the cured product.
The claims in this appeal are also different from those in Thales
Visionix, Inc. v. U.S., 850 F.3d 1343 (Fed. Cir. 2017). In Thales, the
improvement was found to be in the “combination of sensor placement and
calculation based on a different reference frame.” Id. at 1348. Although the
claims used mathematical equations to determine the position of a moving
object relative to a moving reference frame, the court found that the claims
were eligible for a patent under § 101 because they were “directed to
systems and methods that use inertial sensors in a non-conventional manner
to reduce errors in measuring the relative position and orientation of a
moving object on a moving reference frame.” Id. at 1348–1349. In this
appeal, Appellant has not provided evidence that the manner in which the
cytometer is used enables the subsequent steps to provide an indication of
cancer. Rather, it is the abstract idea as whole embodied in claims [b]–[g]
which accomplishes this objective from the measurements initially obtained
from a cytometer.
Appellants argue that claim 1 in this appeal is like Thales because
Thales held that “the computer functionality . . . which qualifies to be patent-
eligible, includes not only the functionality that computers are meant to
perform, such as memory access, but also the functionality that computers
are programmed to perform, such as the functionality of location sensors for
calculating the location and orientation of an object.” Appeal Br. 22. We do
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not agree because Thales, as discussed above, specifically held the eligibility
to reside in the “combination” of the sensors and the mathematical concepts.
Thales, 850 F.3d at 1348 (“this combination of sensor placement and
calculation based on a different reference frame mitigates errors by
eliminating inertial calculations with respect to the earth”).
We are also not persuaded by Appellant’s argument that Finjan, Inc.
v. Blue Coat Sys., 879 F.3d 1299 (Fed. Cir. 2018), would lead to a different
decision. In Finjan, the court drew an analogy to the self-referential table in
Enfish, LLC v. Microsoft Corporation, 822 F.3d 1327 (Fed. Cir. 2016),
finding that the claims were not be directed to an abstract idea, inter alia,
because “the method of claim 1 employs a new kind of file that enables a
computer security system to do things it could not do before.” Id. at 1305.
Here, rejected claim 1 does not employ computer functionality to achieve a
result as in Finjan and Enfish. None of steps [b]–[g] involve computer
functionality, e.g., virus-scanning in Finjan. The steps are performed on a
generic computer, using the computer as computing device without affecting
its functionality. Likewise, Appellant’s argument that Core Wireless
Licensing S.A.R.L. v. LG Elecs., Inc., 880 F.3d 1356 (Fed. Cir. 2018)
“changed the landscape of the 101 analysis again and taught that an
improvement to the qualifying computer functionality” may be patent-
eligible (Appeal Br. 23) is inapplicable because an improvement to computer
functionality is not recited in claim 23.
In sum, the recited steps do not improve computer functionality and
the cytometer of claim 1 does not “play a significant part in permitting the
claimed method to be performed” and, therefore, does not “impose a
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meaningful limit on the scope of a claim.” Versata Development Group v.
SAP America, 793 F.3d 1306, 1335 (Fed. Cir. 2015).
Step 2B
Because we determined that the judicial exception is not integrated
into a practical application, we proceed to Step 2B of the 2019 Guidelines,
which asks, as in the Mayo/Alice framework, whether there is an inventive
concept. The claim as a whole must be examined to determine whether it
“also contain[s] other elements or a combination of elements, sometimes
referred to as an ‘inventive concept,’ sufficient to ensure that the patent in
practice amounts to significantly more than a patent upon the natural law
itself.” See Mayo, 566 U.S. at 72–73.
In this step, we also consider whether the elements recited in the claim
constitute “well-understood, routine, conventional activities previously
known to the industry, specified at a high level of generality.” 84 Fed.
Reg. 56.
Appellant provides argument regarding the presence of an inventive
concept recited in the claims, referencing the following limitation recited in
the claim ([g]):
applying, by the CPU, a second threshold (s4) to the ratio
(N3/N4) to evaluate pathology of the epithelial tissues such that
an evaluation result provides an indication of the presence of
cancer suspected cells in the epithelial tissues . . .

wherein the second threshold (s4) is varied, by the CPU,
according to a proportion of the target cells in the collected
sample cells, wherein the proportion is calculated based on the
number (N1) of the target cells and the number (N2) of the non-
target cells.
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Appellant argues that “[t]he important feature of the present invention is that
the threshold value S4 [sic, “s4”] is variable and changed depending on the
ratio (N1/N2), i.e., the ratio between the number (N1) of target cells
included in the region A3 and the number (N2) of non-target cells included
in the region A4” (with reference to Fig. 11A reproduced in the Appeal
Brief). Appeal Br. 8.
Appellant explains that the inventors found “that a variation of the
amount of the target cells still affects the (N3/N4) ratio derived from the
target cells, or more precisely, a variation of the (N1/N2) ratio affects the
(N3/N4) ratio.” Id. Appellant states that the “the use of a single threshold to
evaluate the ratio (N3/N4) could lead to inaccurate results in cancer
screening tests and that the ratio (N3/N4) needs to be evaluated with
different threshold values depending on the ratio (N1/N2).” Id. at 9.
Appellant shows that, by following the steps in the claimed method, a
lab technician would have visually screened fewer samples than compared to
the prior art. Id. at 10. Thus, Appellant states:
[C]laims 1 and 14 recite an unconventional solution to
evaluation of cancer risk level, i.e., a threshold applied to the
(N3/N4) which is variable depending on the . . . [N1/N2] ratio.
The prior art applied a fixed threshold to the (N3/N4) ratio
which can result in inaccurate evaluation of cancer risk level.
The claimed unconventional solution improves the accuracy of
evaluation of cancer risk level. This unconventional method and
resulting improvement highlight that claims 1 and 14 provide
something more than merely an abstract idea.
Appeal Br. 25.
The Examiner acknowledges this solution to the problem of cancer
cell detection, but responded as follows:
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The claimed subject matter appears to merely describe an
alternative way of analyzing input data relating to cell
parameters, i.e., cell size (C) and nucleus size (N). As cited
above, the claimed method recites use of a CPU to perform well
known, routine and conventional tasks that could be executed
by any CPU with normal functionality.
Ans. 11–12.
The “inventive concept” identified by Appellant is an abstract idea,
itself, and is part of a series of steps in the claim which we have found also
to be abstract ideas. Appellant’s explanation of the improvement to cancer
screening expressly points to making the s4 threshold adjustable, which we
determined to be a mental process. Appeal Br. 9–10. As explained in
Parker v. Flook, 437 U.S. 584, 594 (1978):
Even though a phenomenon of nature or mathematical formula
may be well known, an inventive application of the principle
may be patented. Conversely, the discovery of such a
phenomenon cannot support a patent unless there is some other
inventive concept in its application.
In this case, Appellant may have discovered that varying the threshold s4
depending on the N1/N2 ratio improves the accuracy of evaluation of cancer
risk level, but the phenomenon is an abstract idea and cannot confer
eligibility on the claims.
For the foregoing reasons, we affirm the Examiner’s determination
that claim 1 is ineligible for a patent under § 101. Separate arguments were
not provided for claims 2–6 and 13–26 and therefore these claims fall with
claim 1. 37 C.F.R. 41.37(c)(1)(iv).

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CONCLUSION
In summary:
Claims
Rejected
Basis Affirmed Reversed
1–6 and 13–26 § 101 1–6 and 13–26
Overall Outcome 1–6 and 13–26

AFFRIMED