BOONE, JAMES HUNTER. et al.

Patent Trials and Appeals Board

Mar 31, 2020

13457049 - (D) (P.T.A.B. Mar. 31, 2020)

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.
13/457,049 04/26/2012 JAMES HUNTER BOONE 31110.162195 2955
5251 7590 03/31/2020
SHOOK, HARDY & BACON LLP
INTELLECTUAL PROPERTY DEPARTMENT
2555 GRAND BLVD
KANSAS CITY, MO 64108-2613
EXAMINER
BARRON, SEAN C
ART UNIT PAPER NUMBER
1653
NOTIFICATION DATE DELIVERY MODE
03/31/2020 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):
BPARKERSON@SHB.COM
docket.shb@clarivate.com
ipdocket@shb.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
_________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
_________________

Ex parte JAMES HUNTER BOONE, DAVID M. LYERLY,
TRACY D. WILKINS, and ROBERT J. CARMAN

_________________

Appeal 2019-000469
Application 13/457,049
Technology Center 1600
_________________

Before JEFFREY N. FREDMAN, DEBORAH KATZ, and
JOHN E. SCHNEIDER, Administrative Patent Judges.

KATZ, Administrative Patent Judge.

DECISION ON APPEAL
Appellant1 seeks our review2, under 35 U.S.C. § 134(a), of the
Examiner’s decision to reject claims 8–10, 12–18, 24, and 25. We have
jurisdiction 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 TechLab,
Inc.. (Appeal Br. 3.)
2 We consider the Final Office Action issued June 27, 2017 (“Final Act.”),
the Appeal Brief filed April 27, 2018 (“Appeal Br.”), the Examiner’s
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Appellant’s Specification is directed to methods for classifying
patients based on severity of C. difficile disease using a panel of biomarkers.
(See Spec. 3.) Specifically, Appellant presents a method for assessing
disease severity in patients with C. difficile disease based on fecal lactoferrin
levels. (See id. at 5.)
Appellant’s claim 8 recites:
A method of treating a patient with C. difficile disease,
the method comprising:
obtaining a first fecal sample from the patient at a first
time;
obtaining a second fecal sample from the same patient at
a second time later than the first time;
quantifying a first level of lactoferrin in the first fecal
sample;
quantifying a second level of lactoferrin in the second
fecal sample, wherein an increase from the first level to the
second level indicates an increase in severity of C. difficile
disease, and wherein a decrease from the first level to the
second level indicates a decrease in severity of C. difficile
disease, and wherein:
a level of lactoferrin less than 7.25 μg/mL indicates mild
C. difficile disease,
a level of lactoferrin between 7.25 μg/mL to 99.99
μg/mL indicates moderate C. difficile disease, and
a level of lactoferrin equal to or greater than 100 μg/mL
indicates moderate-to-severe C. difficile disease;
comparing the first level of lactoferrin in the first fecal
sample with the second level of lactoferrin in the second fecal

Answer issued on August 24, 2018 (“Ans.”), the Reply Brief filed October
24, 2018 (“Reply Br.”) in reaching our decision.
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sample to identify a change in level of the lactoferrin between
the first time and the second time;
based on the change in the level of the lactoferrin,
determining that the severity of the C. difficile disease is
increasing or determining that the severity of the C. difficile
disease is decreasing; and
administering a treatment for treating C. difficile to the
patient after obtaining the second fecal sample based on the
increase in the severity of the C. difficile disease or based on the
decrease in the severity of the C. difficile disease.
(Appeal Br. 26–27.) Appellant also presents independent claim 14, which
recites a similar method. (See id. at 27–28.)
The Examiner rejected Appellant’s claims as being drawn to ineligible
subject matter under 35 U.S.C. § 101 and as being obvious under 35 U.S.C.
§ 103. Our analysis below applies to both independent claims 8 and 14 for
the rejection under 35 U.S.C. § 101. Appellant does not present separate
arguments for any of the claims rejected under 35 U.S.C. § 103.
Accordingly, we focus on claim 8 in our review.
35 U.S.C. § 101
The Examiner rejects Appellant’s claims 8–10, 12–14, 24, and 25 as
being directed to patent ineligible subject matter under 35 U.S.C. § 101.
(See Ans. 3–8.) The Examiner determines that the method of treating recited
in claim 8 is directed towards the judicial exception of a law of nature,
specifically the correlation between quantities of lactoferrin in a subject and
the severity of C. difficile infection in the subject. (See Ans. 5.) The
Examiner explains that both changes in fecal lactoferrin concentration
detected in a subject infected with C. difficile and how an infected subject is
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affected generic medical treatment are natural consequences of the growth of
C. difficile in the subject. (See Ans. 5.)
The Examiner then determines that the additional elements of claim 8
do not amount to significantly more than the judicial exception. (See id. at
5–8.) The Examiner reviews the prior art, specifically Steiner3, Shen4, van
Langerberg5, Boone6, and Kelly7, to show that it was known to measure
fecal lactoferrin titers in patients with C. difficile disease and to determine
the best therapeutic treatment options that were available for disease of
differing severity. (See Ans. 5–8.)
We disagree with the Examiner that claim 8 is directed to ineligible
subject matter because we disagree that it is directed a law of nature or an
abstract idea.
To determine if claimed subject matter is statutorily eligible in light of
the judicial exception of a law of nature, the Supreme Court has articulated a
two-step framework in Mayo Collaborative Services v. Prometheus Labs.,
Inc., 566 U.S. 66 (2012), and later cases. First, we determine whether the
claims at issue are directed to one of those patent-ineligible concepts. If so,

3 Steiner, et al., “Fecal lactoferrin, interleukin-1beta, and interleukin-8 are
elevated in patients with severe Clostridium difficile colitis,” Clin. Diagn.
Lab. lmmunol. 4:719–22 (1997).
4 Shen et al., “Current Treatment Options for Severe Clostridiun1 difficile-
associated Disease,” Gastroenterology and Hepatology, 4:134–39 (2008),
5 Van Langerberg, et al., “The potential value of faecal lactoferrin as a
screening test in hospitalized patients with diarrhea,” Internal Medicine
Journal, 40:819–27 (2010).
6 Boone et al. U.S. Patent 7,192,724 B2, issued March 20, 2007.
7 Kelly et al., “Clostridium Difficile Colitis,” The New England Journal of
Medicine, 330:257–62 (1994).
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we then must ask, if there is anything else in the claims. 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. v. CLS Bank Int’l, 573 U.S. 216, 217 (2014) (quoting Mayo, 566 U.S.
at 78).
The USPTO published revised guidance on the application of § 101 in
2019. (See USPTO, 2019 Revised Patent Subject Matter Eligibility
Guidance, 84 Fed. Reg. 50–57 (2019) (“2019 Guidelines”).) After
determining that claimed subject matter falls within the four categories of
eligible subject matter identified in 35 U.S.C. § 101, the 2019 Guidelines
provides a “revised step 2A,” which corresponds to the first step of the
Alice/Mayo test articulated above, to determine whether a claim is directed
to a judicial exception. (See 2019 Guidelines, 84 Fed. Reg. at 53–54.) In a
first prong of revised step 2A, the Examiner must determine whether the
claim recites a judicial exception. (See id. at 54.) If a judicial exception is
identified, the second prong requires a determination of whether the judicial
exception is integrated into a practical application. (See id.) If so, the
inquiry ends and the claim is determined to be directed to eligible subject
matter under the 2019 Guidelines. (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 determine if the
claim provides an inventive concept. (See id. at 56.)
Although claim 8 recites a correlation between lactoferrin levels and
severity of C. difficile disease, we are not persuaded that when all of the
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elements of the claim are considered together, the whole claim is directed to
a natural law. Claim 8 recites: “wherein an increase from the first level to
the second level indicates an increase in severity of C. difficile disease, and
wherein a decrease from the first level to the second level indicates a
decrease in severity of C. difficile disease.” (Appeal Br. 26.) But claim 8
also recites a step of delivering a treatment based on that correlation:
“administering a treatment for treating C. difficile to the patient after
obtaining the second fecal sample based on the increase in the severity of the
C. difficile disease or based on the decrease in the severity of the C. difficile
disease.” (Id.)
Contrary to the Examiner’s determination, we agree with Appellant
that claim 8 is more akin to the claims in Vanda Pharm., Inc. v. West-Ward
Pharm. Int’l Ltd., 887 F.3d 1117 (Fed. Cir. 2018), than to the claims in
Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012).
(See Appeal Br. 10; see Ans. 18.) In Vanda, the claims recited a correlation
between the risk of a cardiac problem, “QTc prolongation,” in patients
depending on whether they exhibit the specific the genotype of a “CYP2D6
poor metabolizer.” Vanda, 887 F.3d 1117, 1121 (Fed. Cir. 2018). But the
claims also required “internally administering iloperidone to the patient in an
amount of 12 mg/day or less” if the patient has a CYP2D6 poor metabolizer
genotype and “internally administering iloperidone to the patient in an
amount that is greater than 12 mg/day, up to 24 mg/day” if the patient does
not have a CYP2D6 poor metabolizer genotype. Id. Thus, although the
claims in Vanda recited a correlation, they also used that correlation for an
actual treatment step. These claims were found to be patent eligible under
35 U.S.C. § 101. See id. at 1136.
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In contrast, the claims in Mayo recited a correlation between the level
of “6-thioguanine” and the need for a drug providing this compound. See
Mayo, 566 U.S. 74–75. These claims were found to not be patent eligible
under 35 U.S.C. § 101. See id. at 92. Specifically, claim 1 in Mayo recited,
in part:
wherein the level of 6–thioguanine less than about 230 pmol per
8x108 red blood cells indicates a need to increase the amount of said
drug subsequently administered to said subject and wherein the level
of 6–thioguanine greater than about 400 pmol per 8x108 red blood
cells indicates a need to decrease the amount of said drug
subsequently administered to said subject.

(Id.) Although the claim recited an indication for a need to increase the
amount of drug based on a correlation with the level of the drug present, the
claim did not use that correlation for an actual treatment step, such as
required in Vanda. This difference was noted in Vanda, where the court
noted: “the claims in Mayo stated that the metabolite level in blood simply
‘indicates’ a need to increase or decrease dosage, without prescribing a
specific dosage regimen or other added steps to take as a result of that
indication.” (Vanda, 887 F.3d at 1135.)
The Federal Circuit has affirmed the eligibility of other claims that
similarly recite an actual treatment step. The claims in Endo Pharm. Inc. v.
Teva Pharm. USA, Inc., 919 F.3d 1347, 1350–51 (Fed. Cir. 2019), were held
to be eligible because they were drawn to a method of treating pain in a
really impaired patient, comprising “providing a solid oral controlled release
dosage form,” while also requiring measurement of a creatinine clearance
rate of the patient and administering a lower dosage “in dependence on
which creatinine clearance rate is found.” The court determined that the
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claims are patent-eligible because they are directed to a method of using
oxymorphone to treat pain with a dosage regimen, even though these steps
are based on the results of kidney function testing. (See id. at 1353–54.)
Most recently, in Boehringer Ingelheim Pharm. Inc. v. Mylan Pharm.,
Inc., No. 2019-1172 (Fed. Cir. March 16, 2020) (non-precedential), claims
to a method of treating and/or preventing metabolic diseases comprising
“orally administering to the patient” a recited class of drugs (DPP-IV
inhibitor) was determined to be eligible. The court explained that
“consistent with this court’s decision in Vanda . . ., the claims are directed to
a particular method of treatment under step one and are therefore patent
eligible.” (Slip. op at 6.) The court addressed the reliance of the claimed
method on a naturally occurring correlation, stating, “[t]hat ‘certain DPP-IV
inhibitors (including linagliptin) are metabolized by the liver rather than the
kidney,’ . . . ‘does not make the claim “directed to” that natural ability.’”
(Slip op. at 7 (quoting Appellee’s Brief and Rapid Litigation Mgmt., Ltd. V.
CellzDirect, Inc., 827 F.3d 1042, 1049 (Fed. Cir. 2016).)
Like the claims in Vanda, Endo, and Boehringer, Appellant’s claims
recite a method of treating a patient by “administering a treatment for
treating C. difficile to the patient” based on a determined increase or
decrease in severity of C. difficile disease correlated to levels of lactoferrin.
Appellant’s claims are not directed solely to the correlation between severity
of the disease and lactoferrin levels.
The Examiner did not consider the administering step of Appellant’s
claims to meaningfully limit the additional elements beyond the mental
steps. (See Ans. 18–19.) But given the specific ways that such
administration is described in Appellant’s Specification (see Spec. 4) and
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further expressed in dependent claims 10 and 12, we are persuaded that such
administration is indeed significant to a method of treatment and limits the
recited mental comparison step to an active method.
Looking to the 2019 Guidelines we begin with the first prong of
“revised step 2A” to determine whether a claim is directed to a judicial
exception. (See 2019 Guidelines, 84 Fed. Reg. at 54.) We agree with the
Examiner that the phrase in Appellant’s claim 8, “based on the change in the
level of the lactoferrin, determining that the severity of the C. difficile
disease is increasing or determining that the severity of the C. difficile
disease is decreasing,” recites the abstract idea of correlating the severity of
C. difficile disease to change in fecal lactoferrin concentration. (See Ans. 5.)
Having determined that claim 8 recites a judicial exception, we turn to
the second prong, which requires a determination of whether the judicial
exception is integrated into a practical application. (See 2019 Guidelines, 84
Fed. Reg. at 54–55.) The Guidelines explain that a practical application can
be “an additional element that applies or uses a judicial exception to effect a
particular treatment or prophylaxis for a disease or medical condition.” (Id.
at 55.) Claim 8 includes the phrase “administering a treatment for treating
C. difficile to the patient after obtaining the second fecal sample based on the
increase in the severity of the C. difficile disease or based on the decrease in
the severity of the C. difficile disease.” This phrase provides the practical
application of administering a treatment to affect C. difficile disease based
on a correlation to increase or decrease in lactoferrin concentrations.
Because claim 8 provides a practical application based on the
correlation recited, claim 8 is not directed to the judicial exception of an
abstract idea or a law of nature. Thus, under the 2019 Guidelines,
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Appellant’s claim 8 is directed to patent-eligible subject matter. As
explained in Natural Alternatives Int'l, Inc. v. Creative Compounds, LLC,
918 F.3d 1338, 1345 (Fed. Cir. 2019), Appellant’s claims rely on a
relationship, but require specific steps be taken in order to bring about a
change in a subject, because they are ultimately treatment claims.
Accordingly, we are not persuaded that claim 8 is directed to
ineligible subject matter. We reach the same conclusion for Appellant’s
other pending claims.
35 U.S.C. § 103
The Examiner also rejected Appellant’s claims as being obvious over
the prior art. Specifically, the Examiner rejected claims 8, 10, 12, 14, 24,
and 25 under 35 U.S.C. § 103 over Steiner, Shen, Kelly, van Langenberg,
and Boone. (See Ans. 9–15.)
Appellant argues that the Examiner erred in rejecting claim 8 and that
because claim 14 recites language similar to that of claim 8, the arguments
apply to claim 8 as well. (See Appeal Br. 23.) Appellant does not raise
separate arguments about the claims that depend on claims 8 and 14.
Accordingly, we focus on claim 8 in our review. See 37 C.F.R. § 41.37(c)
(the Board may select a single claim from a group of claims argued together
and may decide the appeal as to the ground of rejection with respect to the
group on the basis of the selected claim alone).
We make the following findings of fact, based on the Examiner’s
findings provided in the Answer as noted.
1. Steiner teaches a method of isolating fecal samples from
patients with C. difficile disease and teaches that patients with severe disease
have higher levels of lactoferrin. (Steiner 719–20 (“As shown in Fig. 1, the
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patients with severe disease had significantly higher fecal IL-8
concentrations (P = 0.0045), [fecal lactoferrin] titers (P = 0.021), and fecal
IL-1β/IL-1ra ratios (P = 0.025) than patients with mild disease.”) and Table
1; see Ans. 10.)
2. Shen teaches treating moderately ill C. difficile patients with
metronidazole and treating severely ill patients with vancomycin. (See
Shen, Abstract; see Ans. 11.)
3. Shen teaches that there is a known trend in using “appropriate
treatment regimens” for treating refractory C. difficile. (Shen, Abstract.)
4. Kelly demonstrates that it was known to diagnose and confirm
recurrent C. difficile disease by obtaining a second stool sample. (See Kelly
261; see Ans. 11–12.)
5. van Langerberg teaches methods of diagnosing hospital-
acquired inflammatory diarrhea, such as that caused by C. difficile, by
determining fecal lactoferrin concentration (See van Langerberg, Abstract;
see Ans. 12).
6. van Langerberg teaches that fecal lactoferrin could be detected
in the range of 0-288 μg/ml using a commercially available product. (See
van Langerberg 821; see Ans. 12.)
7. van Langerberg teaches that the commercial product was
known to have a “cutoff concentration” for fecal lactoferrin of 7.25 μg/ml,
below which inflammatory diarrhea can be excluded in some settings. (See
van Langerberg, 821, Table 3; see Ans. 12.)
From these findings of fact, the Examiner determines that a person of
ordinary skill in the art would have had a reasonable expectation of success
in Appellant’s claimed method of treatment because Steiner, Shen, and
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Kelly teach that fecal lactoferrin was a known biomarker for C. difficile
disease and that there are different protocols for treating C. difficile disease
of differing severity. (See Ans. 13.) The Examiner also determines that
because van Langerberg demonstrates that 7.25 μg/ml lactoferrin was a
known cut-off for mild disease using a commercially available product and
that lactoferrin concentrations of up to 288 μg/ml had been measured in
patients, using the lactoferrin concentration criteria recited in claim 8 would
have been at least obvious to try. (See id. at 13.)
Appellant argues, in a first “prong,” that the Examiner erred by
concluding that the cited references indicate there was a need or a problem
to be solved in the art. (See Appeal Br. 16–18.) According to Appellant,
“asserting that there are different treatment methods corresponding to
different severity levels of C. difficile does not necessarily evidence that
there is a need to improve the actual diagnostic methods for determining C.
difficile severity.” (Appeal Br. 17.)
We disagree with Appellant because the Examiner points to the
teaching in Shen of different treatments for C. difficile disease depending on
the severity. (See Ans. 21.) We find the Examiner’s explanation of the
reason one of ordinary skill in the art would have looked for a new way to
treat C. difficile disease as being reasonable. Specifically, we find it
reasonable that because those of ordinary skill knew that there was a
correlation between lactoferrin levels and disease severity, as taught in
Steiner, there would have been a reason to develop a new method of
treatment based on the known treatments for disease of differing severity, as
taught in Shen. (See Ans. 21–22.) As the Supreme Court explained in KSR
Int'l Co. v. Teleflex Inc., 550 U.S. 398, 419 (2007):
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In many fields it may be that there is little discussion of obvious
techniques or combinations, and it often may be the case that market
demand, rather than scientific literature, will drive design trends.
Granting patent protection to advances that would occur in the
ordinary course without real innovation retards progress and may, in
the case of patents combining previously known elements, deprive
prior inventions of their value or utility.

The Examiner’s determination that the method of claim 8 would have been
obvious based on the teachings of the cited art, considered as a whole, is
supported by that art.
Appellant argues further, in a second “prong,” that the Examiner erred
in determining there were a finite number of identified, predictable potential
solutions for the problem of new methods of treating C. difficile disease.
(See Ans. 19–20.) Specifically, Appellant argues that the Examiner erred in
finding that van Langenberg provides an upper limit of fecal lactoferrin
concentration of 288 µg/ml or that van Langenberg suggests that patients do
not exhibit fecal lactoferrin concentrations greater than 288 µg/ml. (See id.
at 19.) Appellant argues that van Langenberg only teaches a range of patient
lactoferrin concentrations, but that nothing in van Landenberg indicates that
the measurable fecal lactoferrin concentration is capped at 288 µg/ml. (See
Ans. 19.)
This argument is also unpersuasive. The Examiner did not rely on the
teaching in van Langenberg of the range of 0–288 µg/ml as a cap or absolute
limit on the level of fecal lactoferrin. Nor does Appellant’s claim 8 require
an upper limit of lactoferrin concentration. (See id. at 22.) Instead, we agree
with the Examiner that given the knowledge in the art about the
concentration of lactoferrin providing an insight into the severity of C.
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difficile disease and the limitations of the commercially available lactoferrin
assays, the claimed lactoferrin ranges recited in claim 8 would have been
obvious to one of ordinary skill in the art.
We note that Appellant does not direct us to any evidence of the
criticality of the ranges for fecal lactoferrin recited claim 8. Given that the
lower range recited in claim 8 (7.25 µg/ml) is expressly taught in van
Langenberg as being a cutoff concentration for inflammatory diarrhea (see
van Langenberg 821), and Appellant does not direct us to evidence of the
criticality of the upper ranges (7.25 μg/mL to 99.99 μg/mL; greater than 100
μg/mL) we are not persuaded that the absence of a teaching of these specific
ranges in the prior art renders claim 8 non-obvious. Instead, we agree with
the Examiner that it would have been obvious to at least try these ranges in
an optimization of the method of treatment.
Appellant argues, in a third “prong,” that the Examiner erred in
concluding that the claimed method would have had a reasonable
expectation of success because van Langenberg does not define a boundary
for concentration of fecal lactoferrin and Steiner does not show any
correlation between increasing lactoferrin concentration and increasing C.
difficile symptom severity. (See Ans. 20–22.)
In general, we are not persuaded by Appellant’s argument because the
Examiner’s rejection is based on obviousness, not anticipation. As
explained above, given the van Langenberg teaches ranges of lactoferrin
concentration that are at least similar to the claimed ranges, the absence of
the same ranges recited in claim 8 does not mean that those ranges would
not have been obvious. van Langenberg does not need to teach a boundary
for lactoferin concentration to render the claimed ranges obvious, rather it
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teaches the use of a commercially available product to assay lactoferrin at
concentrations as recited in claim 8. (See Ans. 22.)
We are also not persuaded by Appellant’s argument regarding Steiner.
Appellant argues that Steiner teaches diagnosis of the severity of disease
when lactoferrin is either greater or less than a 1:50 titer, indicating only
severe symptoms or not. (See Appeal Br. 21–22.) According to Appellant,
these two alternatives (severe symptoms or not) do not suggest a direct
relationship between an increasing concentration of fecal lactoferrin and an
increasing severity of C. difficile. (See id.)
We disagree. Steiner teaches: “As shown in Fig. 1, the patients with
severe disease had significantly higher fecal IL-8 concentrations (P =
0.0045), [fecal lactoferrin] titers (P = 0.021), and fecal IL-lβ/IL-Ira ratios (P
= 0.025) than patients with mild disease.” (Steiner 720 (emphasis added).)
We agree with the Examiner that this is not merely a teaching of absolute
alternatives, but is at least a suggestion that the degree of severity of C.
difficile disease is correlated with the concentration of fecal lactoferrin. (See
Ans. 23.) Even though Steiner reports results for only “severe disease” and
“mild disease,” the expression of “higher” concentrations indicates a range
of responses, not an all or none situation.
Similarly the abstract of Steiner states: “A review of the 18 available
patient records revealed that fecal IL-8 concentrations, IL-lβ/IL-lra ratios,
and [fecal lactoferrin] titers were significantly higher in patients with
moderate to severe disease than in patients with mild disease.” Thus, Steiner
contemplates mild, moderate, and severe disease. Because the Examiner’s
rejection is for obviousness not anticipation, there was no error in relying on
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Steiner to suggest the level of fecal lactoferrin can indicate the severity of
disease.
Appellant argues, in a fourth “prong,” that the Examiner has not
provided any “additional” reasons to show that one of ordinary skill would
find it obvious to stratify the diagnosis of C. difficile severity based on a
correlation between the severity of C. difficile and the claimed fecal
lactoferrin levels. (Appeal Br. 23.) Because we are persuaded by the
findings and reasoning provided by the Examiner, no “additional” reasons
are necessary.
In summary, Appellant fails to persuade us that the Examiner erred in
rejecting claim 8 as being obvious over the cited prior art. Appellant
provides no other arguments in regard to independent claim 14 or the claims
that depend on either claim 8 or 14. Accordingly, we are not persuaded that
the Examiner erred in rejecting these claims either.
The Examiner rejected claim 13 as being obvious over those
references as well as Aas8 and claims 15–18 over those references as well as
Reller9. (See id. at 14–17). Appellant does not raise separate arguments
against the rejection of those claims, stating that “[b]ased at least on” the
dependency from independent claim 8 or claim 14, the cited references do

8 Aas, et al., “Recurrent Clostridium difficile Colitis: Case Series Involving
18 Patients Treated with Donor Stool Administered via a Nasogastric Tube,”
Clinical Infectious Diseases, 36:580–85 (2003).
9 Reller et al., “Yield of Stool Culture with Isolate Toxin Testing versus a
Two-Step Algorithm including Stool Toxin Testing for Detection
of Toxigenic Clostridium difficile,” Journal of Clinical Microbiology,
45:3601–05 (2007).
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not teach or suggest each and every element of the claims. (See Appeal Br.
24.)
Because we are not persuaded that the Examiner erred in the rejection
of claim 8 under 35 U.S.C. § 103, we are not persuaded that the Examiner
erred in the rejections of any of the other claims.

Conclusion
Upon consideration of the record and for the reasons given, we affirm
the Examiner’s rejection.
In summary:
Claims
Rejected
35 U.S.C. § References
/Basis
Affirmed Reversed
8–10, 12–14,
24, 25
101 8–10, 12–14,
24, 25
8, 10, 12, 14,
24, 25
103 Steiner, Shen,
Kelly, van
Langerberg,
Boone
8, 10, 12, 14,
24, 25

13 103 Steiner, Shen,
Kelly, van
Langerberg,
Boone, Aas
13
15–18 103 Steiner, Shen,
Kelly, van
Langerberg,
and Boone,
Aas, Reller
15–18
Overall
Outcome
8, 10, 12–18,
24, 25

Appeal 2019-000469
Application 13/457,049

18
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136.

AFFIRMED