Northwestern University

Patent Trials and Appeals Board

May 4, 2020

13772796 - (D) (P.T.A.B. May. 4, 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.
13/772,796 02/21/2013 Thomas W. McDade 702581.00478.NU2012-004 6018
69220 7590 05/04/2020
Quarles & Brady LLP (Northwestern)
Attn: IP Docket
411 East Wisconsin Ave
Milwaukee, WI 53202-4426
EXAMINER
MARCSISIN, ELLEN JEAN
ART UNIT PAPER NUMBER
1641
NOTIFICATION DATE DELIVERY MODE
05/04/2020 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):
pat-dept@quarles.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte THOMAS W. MCDADE,
WILLIAM E. FUNK, and DAVID B. SEIFER
____________

Appeal 2019-004750
Application 13/772,796
Technology Center 1600
____________

Before FRANCISCO C. PRATS, RACHEL H. TOWNSEND, and
CYNTHIA M. HARDMAN, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 40–59. 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 states that the “the real party in interest is
Northwestern University, by assignment from the inventors recorded in the
U.S. Patent and Trademark Office on March 7, 2013, at Reel 029940, Frame
0787.” Appeal Br. 1.
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STATEMENT OF THE CASE
The following rejections are before us for review:
(1) Claims 40, 41, and 46, under pre-AIA 35 U.S.C. § 102(b) as
anticipated by INSERM2 (Ans. 3–4);
(2) Claims 56, 58, and 59, under 35 U.S.C. § 103(a) as unpatentable
over INSERM and McDade3 (Ans. 4–7);
(3) Claims 40–46, 49, 50, and 54, under 35 U.S.C. § 103(a) as
unpatentable over Place4 and INSERM (Ans. 7–14);
(4) Claims 40–50 and 54–59, under 35 U.S.C. § 103(a) as
unpatentable over Place, INSERM, and McDade (Ans. 14–21); and
(5) Claims 51–53, under 35 U.S.C. § 103(a) as unpatentable over
Place, INSERM, McDade, and Mohammed5 (Ans. 21–22).
Independent claims 40 and 56 are representative and read as follows:
40. A method comprising:
a) contacting a whole blood sample from a finger
stick of a subject directly with labeled antibodies
specific for Anti-Mullerian hormone (labelled anti-
AMH antibodies) under conditions whereby an
aggregate is formed comprising the labelled anti-
AMH antibodies and AMH in the whole blood
sample, wherein the labelled anti-AMH antibodies
are labeled with nanoparticles that generate a
colorimetric or fluorescent signal when the
aggregate is formed and the colorimetric or
fluorescent signal has an intensity that is

2 EP 2 161 579 A1 (published Aug. 26, 2008).
3 Thomas W. McDade et al., What a Drop Can Do: Dried Blood Spots as a
Minimally Invasive Method for Integrating Biomarker in Population-Based
Research, 44 DEMOGRAPHY 899–925 (2007).
4 US 2009/0275060 A1 (published Nov. 5, 2009).
5 US 2008/0254441 A1 (published Oct. 16, 2008).
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proportional to concentration of AMH in the whole
blood sample; and
b) detecting the intensity of the signal.
56. A method comprising:
a) obtaining a whole blood sample from a finger
stick of a subject;
b) contacting the whole blood sample from the finger
stick of the subject directly with labeled antibodies
specific for Anti-Mullerian hormone (labelled anti-
AMH antibodies) under conditions whereby an
aggregate is formed comprising the labelled anti-
AMH antibodies and AMH in the whole blood
sample, wherein the labelled anti-AMH antibodies
are labeled with nanoparticles that generate a
colorimetric or fluorescent signal when the
aggregate is formed and the colorimetric or
fluorescent signal has an intensity that is
proportional to concentration of AMH in the whole
blood sample; and
c) detecting the intensity of the signal.
Appeal Br. 23, 26 (emphasis added to limitation primarily at issue).
ANTICIPATION
The Examiner’s Rejection
In rejecting claims 40, 41, and 46 as anticipated by INSERM, the
Examiner determined that INSERM described a process for detecting Anti-
Mullerian hormone (AMH). Ans. 3. The Examiner found that INSERM’s
process included directly contacting a whole blood sample with labeled
antibodies encompassed by the claims, thereby forming an aggregate, and
then detecting the intensity of the signal of the labeled antibodies. Id. at 3–4.
The Examiner determined, as to the limitation “contacting a whole
blood sample from a finger stick of a subject,” that independent claim 40
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“does not actually include/recite a step of obtaining a finger stick blood
sample. This recitation is a product-by-process limitation, defining the
manner in which the whole blood sample is obtained.” Ans. 4.
The Examiner determined that the “process by which the whole blood
sample is obtained does not clearly impart any structural differen[ce] in this
case to the resultant whole blood sample,” and “[a]s no clear limitations are
apparent as a result of this product by process limitation, it is Appellant’s
burden to establish an unobvious difference between the claimed invention
and the cited art. See MPEP 2113.” Ans. 4.
Specifically, the Examiner reasoned, “it is the case that a whole blood
sample as recited by INSERM is the same as a whole blood sample presently
claimed (whether obtained by a finger stick or by another means, the whole
blood sample is expected to be the same)[;] as such, INSERM anticipates the
claim.” Ans. 4.
Analysis
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden . . . of presenting a
prima facie case of unpatentability. . . .
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
Having carefully considered the arguments and evidence advanced by
Appellant and the Examiner, Appellant persuades us that the preponderance
of the evidence does not support the Examiner’s determination that
INSERM describes a process having all of the steps and features required by
rejected claims 40, 41, and 46. In particular, we agree with Appellant that
the Examiner has not shown sufficiently that INSERM describes contacting
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a whole blood sample “from a finger stick of a subject” directly with labeled
anti-AMH antibodies, as recited in Appellant’s independent claim 40.
Appeal Br. 23.
INSERM describes a method for “quantifying the presence of at least
one biologically active form of Anti-Müllerian Hormone (AMH) in a
sample, said method comprising detecting the presence of cleaved AMH or
C-terminal AMH in said sample.” INSERM ¶ 39 (emphasis added).
INSERM discloses that, in one embodiment, “quantification of at least
one of the biologically active forms of AMH in a sample may be achieved
by a competitive immunoassay. Example[s] of competitive immunoassays
include . . . fluorescent immunoassay[s].” INSERM ¶ 54 (emphasis added).
INSERM discloses that “the sample susceptible to contain biological
active forms of AMH is a biological sample, such as cell lysates or culture
medium, or is a body fluid such as whole blood, serum, plasma, follicular
fluid, seminal fluid, synovial fluid, cerebrospinal fluid, saliva, or urine.”
INSERM ¶ 48 (emphasis added).
INSERM discloses that, “[i]n a preferred embodiment, said sample is
a serum sample, a whole blood sample, a plasma sample, a follicular fluid
sample, a seminal fluid sample.” INSERM ¶ 49 (emphasis added).
As noted above, the Examiner determined that INSERM’s disclosure
of quantifying AMH in a whole blood sample necessarily, that is inherently,
describes using a sample from a finger stick of a subject, as recited in
Appellant’s claim 40, because a whole blood sample from a finger stick is
indistinguishable from other types of whole blood samples. See Ans. 4.
We are not persuaded. A number of references cited by Appellant
support Appellant’s contention that the composition of a whole blood
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sample from a finger stick is not necessarily the same as the composition of
other types of whole blood samples, e.g., as obtained from venipuncture.
See Kupke 19816 (disclosing that “concentrations of various clinical-
chemical substances in the capillary and venous blood serum of apparently
healthy adults (20–30 yr) were examined in the fasting state” and that
“[t]otal protein, bilirubin, calcium, sodium and chloride concentrations were
significantly lower (≤ 5%) in capillary than in venous serum”); see also
Larsson-Cohn7 (disclosing that simultaneous measurement of capillary and
venous blood glucose concentrations during oral glucose tolerance tests
produced significantly different results in samples taken after 15–90 minutes
“indicat[ing] that the verdict [as to ‘normal’ or ‘abnormal’] will in some
cases be influenced by the route by which the blood was obtained”); see also
Moe8 (disclosing comparison of hemoglobin, hematocrit, and red blood cell
evaluations in capillary (“skin-prick”) and venous blood in 30 adults and 30
children and finding that “[h]igher mean values were found in venous blood,
particularly in the children”).
It is undisputed on this record that INSERM does not expressly
describe using a whole blood sample from a finger stick of a subject as the
sample in which AMH is detected. Because the composition of a blood

6 I.R. Kupke, On the composition of capillary and venous blood serum, 112
CLIN. CHIM. ACTA 177–185 (1981) (abstract only).
7 U. Larsson-Cohn, Differences between Capillary and Venous Blood
Glucose during Oral Glucose Tolerance Tests, 36 SCANDINAVIAN JOURNAL
OF CLINICAL & LABORATORY INVESTIGATION 805–808 (1976) (abstract
only).
8 P.J. Moe, Hemoglobin, Hematocrit and Red Blood Cell Count in
“Capillary (Skin-Prick) Blood Compared to Venous Blood In Children, 59
ACTA PAEDIATRICA 49–51 (1970) (abstract only).
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sample can vary depending on whether the sample is venous blood, as
opposed to blood obtained from a finger stick (see, e.g., Kupke 1981;
Larsson-Cohn; Moe), we are not persuaded by the Examiner’s product-by-
process rationale, and thus find insufficient support for the Examiner’s
finding that INSERM’s generic disclosure of using a whole blood sample
(see INSERM ¶¶ 48, 49) inherently describes using a whole blood sample
from a finger stick of a subject, as recited in Appellant’s claim 40. We
therefore agree with Appellant that INSERM does not anticipate
independent claim 40, or its dependent claims 41, 46.
The Examiner contends that Kupke 1981, Larsson-Cohn, and Moe do
not show that INSERM does not anticipate claim 40, because the differences
between venous and skin prick blood as to the analytes evaluated in those
references do not establish that AMH would be undetectable in a whole
blood sample from a finger stick of a subject. See Ans. 29–30.
We are not persuaded. It is well settled that, “[t]o anticipate a claim, a
prior art reference must disclose every limitation of the claimed invention,
either explicitly or inherently.” In re Schreiber, 128 F.3d 1473, 1477 (Fed.
Cir. 1997).
In the present case, Appellant’s claim 40 requires the sample in the
claimed process to be “a whole blood sample from a finger stick of a
subject.” Appeal Br. 23. Thus, the issue as to this anticipation rejection is
not, as the Examiner contends, whether a skilled artisan would have
expected INSERM’s whole blood sample to contain an assayable amount of
AMH. Rather, the issue as to the Examiner’s anticipation rejection is
whether the whole blood sample described in INSERM is the same as the
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whole blood sample from a finger stick of a subject, recited in Appellant’s
claim 40.
It is undisputed that INSERM does not explicitly disclose using a
whole blood sample from a finger stick in its process. For INSERM to
inherently describe using a whole blood sample from a finger stick in its
process, it must be unavoidable that INSERM’s sample is the same as a
whole blood sample from a finger stick. See Agilent Technologies, Inc. v.
Affymetrix, Inc., 567 F.3d 1366, 1383 (Fed. Cir. 2009) (“The very essence of
inherency is that one of ordinary skill in the art would recognize that a
reference unavoidably teaches the property in question.”) (emphasis added).
In the present case, as discussed above, Appellant has advanced
evidence that the composition of a whole blood sample differs significantly
depending on whether the sample is from a finger stick, or is a venous blood
sample. We are not persuaded, therefore, that in describing the use of a
“whole blood sample” (INSERM ¶ 49), INSERM unavoidably, i.e.
inherently, describes a sample that is compositionally identical to the whole
blood sample from a finger stick recited in Appellant’s claim 40.
In sum, for the reasons discussed, Appellant persuades us that the
Examiner has not shown by a preponderance of the evidence that INSERM
describes a process that has all of the steps and features required by
Appellant’s claim 40. We therefore reverse the Examiner’s rejection of
claim 40, and its dependent claims 41 and 46, as anticipated by INSERM.
OBVIOUSNESS—INSERM AND MCDADE
The Examiner’s Rejection
In rejecting claims 56, 58, and 59 for obviousness over INSERM and
McDade, the Examiner found that INSERM described a process with nearly
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all of the steps and features recited in the claims, but conceded that INSERM
differs from the claims in that “INSERM fails to teach a step of obtaining
the whole blood sample from a finger stick of a subject.” Ans. 5.
As evidence that Appellant’s claimed process would have been
obvious despite the difference between INSERM and the claimed process,
the Examiner cited McDade as disclosing that, when determining the
concentration of analytes in blood, whole dried blood samples obtained by a
finger stick had a number of advantages over samples obtained through
venipuncture. See Ans. 5–6.
Based on the advantages taught in McDade, the Examiner reasoned
that a skilled artisan would have considered it obvious to modify INSERM’s
method “to first perform a step obtaining the whole blood sample from a
finger stick, as taught by McDade et al., when performing methods for
detection of AMH using whole blood samples as taught by INSERM.”
Ans. 6.
In particular, the Examiner reasoned that “acquiring such blood
samples is minimally invasive, convenient regarding collection (don’t need
medically trained staff, can be performed in home or by participant
themselves), low cost (compared to venipuncture), and allows access to
physiological information that would otherwise be unattainable in a
nonclinical setting (McDade et al.).” Ans. 6.
Analysis
We select claim 56 as representative of the claims subject to this
rejection. See 37 C.F.R. § 41.37(c)(1)(iv). Having carefully considered the
arguments and evidence advanced by Appellant and the Examiner,
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Appellant does not persuade us that the preponderance of the evidence fails
to support the Examiner’s conclusion of obviousness as to claim 56.
Appellant contends it has “provided ample evidence that whole blood
obtained from a finger stick from a subject would not be recognized in the
art as being suitable for directly detecting circulating anti-Mullerian
hormone (AMH) in the subject.” Appeal Br. 16 (citing McDade
Declaration,9 Kelso Declaration,10 Fleming11). We are not persuaded.
As noted above, INSERM discloses “quantification of at least one of
the biologically active forms of AMH in a sample may be achieved by a
competitive immunoassay. Example[s] of competitive immunoassays
include . . . fluorescent immunoassay[s].” INSERM ¶ 54 (emphasis added).
As also noted above, INSERM discloses that, “[i]n a preferred
embodiment, said sample is a serum sample, a whole blood sample, a
plasma sample, a follicular fluid sample, a seminal fluid sample.” INSERM
¶ 49 (emphasis added).
Given INSERM’s express disclosure that its sample in a preferred
embodiment is a whole blood sample, we are not persuaded by Appellant’s
contentions that INSERM does not teach or suggest directly contacting a
whole blood sample with a fluorescently labeled anti-AMH antibody. In
particular, given INSERM’s teaching that any of serum, plasma, or whole
blood are useful samples in its preferred embodiment (INSERM ¶ 49), we
are not persuaded that a skilled artisan would have interpreted INSERM’s

9 Declaration of Thomas W. McDade, Ph.D. (signed Oct. 21, 2014).
10 Declaration of David M. Kelso, Ph.D. (signed Sept. 25, 2015).
11 Richard Fleming et al., Stability of AMH measurement in blood and
avoidance of proteolytic changes, 26 REPRODUCTIVE BIOMEDICINE ONLINE
130–132 (2013).
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disclosure of a whole blood sample as equating to a teaching that antibody-
based quantitation of AMH required serum or plasma separation from the
whole blood. See Appeal Br. 8–10.
And, contrary to Appellant’s contentions that skilled artisans would
have considered whole blood from a finger stick an unsuitable sample for
direct antibody-based quantitation of circulating AMH in a subject, the
McDade reference discloses that a dried whole blood sample from a finger
stick provides a sufficient amount of material for quantifying many analytes
of interest. See McDade 906 (“In most cases, an analyte that can be
measured in serum or plasma can also be assayed in DBS [dried blood spot]
samples.”); see also id. (“The relatively recent development of highly
sensitive and specific immunoassays has facilitated analysis of biomarkers in
small, microliter quantities of blood, but there are limits.”).
McDade explains further:
A typical drop of blood will contain approximately 50 μL of
whole blood and will result in a DBS sample approximately 12
mm in diameter. Such a spot will yield seven 3.2-mm discs of
blood. A full card of five blood spots will, therefore, contain
enough sample to analyze 35 analytes requiring one 3.2-mm
disc, or 17 analytes requiring two such discs.
McDade 907.
We acknowledge the McDade reference’s disclosure that not all
analytes are amenable to quantitation from a DBS. See, e.g., McDade
906 (“[T]here are limits.”); id. at 907 (“In some cases, quantifying an
analyte of interest in DBS samples may not be possible.”).
As our reviewing court has explained, however, “[o]bviousness does
not require absolute predictability of success. . . . For obviousness under
§ 103, all that is required is a reasonable expectation of success.” In re
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Kubin, 561 F.3d 1351, 1360 (Fed. Cir. 2009) (quoting In re O’Farrell, 853
F.2d 894, 903–04 (Fed. Cir. 1988) (emphasis removed).
Given the disclosures in the McDade reference, noted above, that a
dried whole blood sample from a finger stick provides a sufficient amount of
material for quantifying many analytes of interest by immunoassay, we
agree with the Examiner that a skilled artisan would have had a reasonable
expectation of success in using McDade’s whole blood finger stick sample
as the whole blood sample in INSERM’s antibody-based AMH quantitation
process.
We acknowledge the statements in the McDade Declaration that the
state of the art was that skilled artisans would not have expected whole
blood to be useful for accurate determination of AMH levels:
Prior to our determining that whole blood could be used to
accurately detect levels of AMH, it would have been
unexpected that whole blood could be used to accurately detect
levels of AMH. Rather, endocrinologists would have expected
that a serum sample obtained via a venipuncture blood draw
would need to be used in order to accurately detect levels of
AMH (i.e., the current gold-standard serum-based assay
method). This is at least partially because whole blood, in
comparison to serum, is more complex and contains
components that can potentially interfere with accurately
determining AMH levels.
McDade Decl. ¶ 7.
We also acknowledge the similar statement in the Kelso Declaration
that “only a serum sample obtained via a venipuncture blood draw would
have been viewed as a suitable sample for accurately determining
concentration of AMH.” Kelso Decl. ¶ 6.
It is well settled, however, that to be persuasive of nonobviousness, an
expert’s opinion must be supported by objective evidence. See Ashland Oil,
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Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 294 (Fed. Cir. 1985)
(“Lack of factual support for expert opinion going to factual determinations
. . . may render the testimony of little probative value in a validity
determination.”) (citing In re Altenpohl, 500 F.2d 1151, 1158 (CCPA
1974)).
In the present case, neither the McDade Declaration nor the Kelso
Declaration provides any specific objective evidence supporting the
statements that the state of the art was that a dried whole blood sample from
a finger stick, as taught in the McDade reference, would have been
unsuitable for antibody-based AMH quantification methods, as taught in
INSERM. Indeed, neither the McDade Declaration nor the Kelso
Declaration directly addresses the teachings in the McDade reference
discussed above, nor do those declarations explain specifically why the
McDade reference’s teachings would have failed to provide a skilled artisan
with a reasonable expectation of successfully using a whole blood finger
stick sample as the whole blood sample in INSERM’s antibody-based AMH
quantitation process.
We acknowledge the McDade Declaration’s statement that whole
blood contains components that can interfere with accurate AMH
determination. McDade Decl. ¶ 7.
The McDade reference, however, while recognizing potential
interference from cellular components in a whole blood sample from a finger
stick, nonetheless states that “[t]his is not a common problem, although the
presence of lysed red blood cells has proven to be an insurmountable
obstacle in the measurement of ferritin in dried whole blood.” McDade 906
(citation omitted; emphasis added).
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In sum, given the disclosures in the McDade reference that a dried
whole blood sample from a finger stick provides a sufficient amount of
material for quantifying many analytes of interest by immunoassay, the
unsupported statements in the McDade Declaration and Kelso Declaration
do not persuade us that a skilled artisan lacked a reasonable expectation of
success in using the McDade reference’s DBS sample as the whole blood
sample in INSERM’s antibody-based AMH quantitation process.
We are also unpersuaded that the Fleming reference demonstrates that
skilled artisans would have considered the DBS samples described in the
McDade to be an unsuitable sample for INSERM’s antibody-based AMH
quantitation process. Fleming discloses a study in which it was determined
that, if whole blood samples were stored at room temperature for too long
before separation of serum from the samples, accuracy of an antibody-based
assay of AMH in the serum was significantly affected. See Fleming 132
(“It is clear from these results that protracted storage of whole blood at room
temperature profoundly influenced the AMH concentration measured in the
subsequently separated serum.”).
Appellant does not point to, nor do we discern, any specific discussion
in Fleming as to whether the finger stick whole blood DBS samples taught in
the McDade reference would be useful in an antibody-based AMH
quantitation as taught in INSERM. Nor do we discern any disclosure in
Fleming that specifically undermines the teachings in the McDade reference
suggesting that DBS samples would reasonably be successful in INSERM’s
AMH quantitation process.
In sum, for the reasons discussed, Appellant does not persuade us that
the Examiner erred in determining that a skilled artisan had a reasonable
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expectation of success in using the McDade reference’s DBS sample as the
whole blood sample in INSERM’s antibody-based AMH quantitation
process. Appellant also does not persuade us that the Examiner erred in
determining that a skilled artisan had motivation for using the McDade
reference’s DBS sample as the whole blood sample in INSERM’s
antibody-based AMH quantitation process.
As the Examiner points out, the McDade reference discloses that
finger stick whole blood DBS samples have a number of advantages as
compared to venipuncture. See McDade 907 (advantages of DBS as sample
for analyte quantitation include “provid[ing] access to physiological
information that would not otherwise be attainable in nonclinical settings;”
“sample collection is relatively painless and noninvasive;” “unlike plasma or
serum, DBS samples do not need to be centrifuged, separated, or
immediately frozen following collection;” “DBS samples remain stable in
laboratory freezers for long periods of time”). Given the advantages of
finger stick whole blood DBS samples described in the McDade reference,
we agree with the Examiner that a skilled artisan had good reason for
obtaining a whole blood sample from a finger stick of a subject, and directly
contacting that sample with labeled antibodies to quantify AMH, as taught in
INSERM.
Because a skilled artisan had a good reason for, and a reasonable
expectation of success in, using the McDade reference’s whole blood finger
stick DBS samples in INSERM’s labeled antibody-based AMH detection
assays, we agree with the Examiner that the process recited in Appellant’s
claim 56 would have been prima facie obvious. We also agree with the
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Examiner that Appellant has not advanced evidence of unexpected result
sufficient to outweigh the evidence of prima facie obviousness.
As to unexpected results, Appellant contends that, “[s]urprisingly, the
present inventors observed that the correlation between concentrations of
AMH in DBS samples and serum samples was linear across the range of
detected levels as indicated in Figure 1, and the inventors calculated a
Pearson correlation (R) of 0.968, which is very high.” Appeal Br. 17 (citing
Kelso Decl. ¶ 7; emphasis omitted).
As explained in the McDade reference, however, a skilled artisan
would have expected a good correlation between analyte concentrations
determined by finger stick DBS sample, as compared to assays of serum or
plasma. See McDade 906 (“[I]nvestigators can expect performance that is
comparable to that obtained with serum/plasma samples . . . .”); see also id.
at 908 (“[T]he correlations between results derived from matched
serum/plasma and DBS samples are linear and high for most analytes . . . .”).
Moreover, as to the Kelso Declaration’s statement that the small
amount of blood obtained from a finger stick (25 µL) makes assaying AMH
concentration problematic and the results obtained unexpected (see Kelso
Decl. ¶ 7), the McDade reference states that the DBS samples actually
contain 50 µL of whole blood, twice the amount stated in the declaration.
See McDade 905 (“When filled to its border, each circle will contain
approximately 50 μL of whole blood.”); see also id. at 907 (“A typical drop
of blood will contain approximately 50 μL of whole blood . . . .”).
As to unexpected results, Appellant contends that the observed limit
of detection in Appellant’s AMH immunoassay using a DBS sample was
0.052 ng/mL, which “is surprisingly low in comparison to other DBS
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immunoassays used for point of care detection. For example, the limit of
detection for C-reactive protein in a DBS immunoassay typically is > 10-9
g/ml, which is 100-l000× higher than the limit of detection for the inventors’
AMH immunoassay.” Appeal Br. 17 (citing Kelso Decl. ¶ 9; emphasis
omitted).
Although neither Appellant nor the Kelso Declaration cites the
specific portion of the Appellant’s disclosure that supports the statements
regarding the allegedly unexpected lower detection limit, we note the
Specification’s disclosure that “the minimum detectable dose of AMH was
0.052 ng/mL in this Example.” Spec. 22. That result, however, was
obtained using a specific assay protocol using specific reagents (see id. at
18–20), whereas Appellant’s claim 56 does not recite any particular assay
techniques or reagents, other than labeled anti-AMH antibodies. It is well
settled that “[e]vidence of secondary considerations must be reasonably
commensurate with the scope of the claims.” In re Kao, 639 F.3d 1057,
1068 (Fed. Cir. 2011).
Moreover, to the extent Appellant and the Kelso Declaration advance
the C-reactive protein detection limit as a basis for comparison with the
results obtained in Appellant’s Specification, neither Appellant nor the
Kelso Declaration explains specifically where a description of the C-reactive
protein DBS immunoassay appears in the record. On this record, therefore,
the Kelso Declaration’s statement as to typical results of a C-reactive protein
DBS immunoassay, and the alleged unexpectedness of claim 56’s process in
comparison thereto, lack clear objective evidentiary support.
In sum, for the reasons discussed we agree with the Examiner that the
process recited in Appellant’s claim 56 would have been prima facie
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obvious. For the reasons discussed, we also agree with the Examiner that
Appellant has not advanced evidence of unexpected result sufficient to
overcome the evidence of prima facie obviousness. We therefore affirm the
Examiner’s rejection of claim 56 for obviousness over INSERM and
McDade. Claims 58 and 59 fall with claim 56. 37 C.F.R. § 41.37(c)(1)(iv).
OBVIOUSNESS—PLACE AND INSERM
The Examiner’s Rejection
In rejecting claims 40–46, 49, 50, and 54 over Place and INSERM, the
Examiner cited Place as describing a process of using labeled antibodies to
quantify AMH in a plasma, serum, or blood product sample. Ans. 8.
The Examiner conceded that Place differs from the claims in that
“Place does not specifically teach a whole blood sample; and fails to teach
that the whole blood sample is from a finger stick.” Ans. 9. The Examiner
cited INSERM as evidence that it would have been obvious to use a whole
blood sample in Place’s process of quantifying AMH in a subject. Id. at 10.
As to the recitation in independent claims 40 and 49 that the whole
blood sample is obtained from a finger stick, the Examiner again determined
that “[t]he process by which the whole blood sample is obtained does not
clearly impart any structural different in this case to the resultant whole
blood sample.” Ans. 9.
Analysis
For reasons similar to those discussed above in relation to the
anticipation rejection of claim 40 over INSERM, we reverse this rejection.
As discussed above, Appellant has advanced evidence, which the Examiner
has not persuasively rebutted, that whole blood from a finger stick differs
compositionally from other types of whole blood samples.
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Accordingly, on this record, neither Place nor INSERM describes,
expressly or inherently, using labeled antibodies to quantify AMH in a
whole blood sample from a finger stick, as required by claims 40 and 49.
And the Examiner, in this rejection, has not advanced evidence why a skilled
artisan would have considered it obvious to use whole blood from a finger
stick in an antibody-based AMH assay. We therefore reverse the
Examiner’s rejection of claims 40 and 49, and their dependent claims, for
obviousness over Place and INSERM.
OBVIOUSNESS—
PLACE, INSERM, AND MCDADE
The Examiner’s Rejection
In rejecting claims 40–50 and 54–59 over Place, INSERM, and
McDade, the Examiner again cited Place as describing a process of using
labeled antibodies to quantify AMH in a plasma, serum, or blood product
sample. Ans. 14.
The Examiner again conceded that Place differs from the claims in
that “Place does not specifically teach a whole blood sample; and fails to
teach that the whole blood sample is from a finger stick.” Ans. 14. The
Examiner again cited INSERM as evidence that it would have been obvious
to use a whole blood sample in Place’s process of quantifying AMH in a
subject. See id. at 10.
The Examiner cited McDade as evidence that it would have been
obvious to use whole blood from a finger stick as a sample when using
labeled antibodies to quantify AMH in a subject, as taught in INSERM and
Place. Ans. 15–16, 18.
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Analysis
We select claim 56 as representative of the claims subject to this
rejection. See 37 C.F.R. § 41.37(c)(1)(iv). Having carefully considered the
arguments and evidence advanced by Appellant and the Examiner,
Appellant does not persuade us that the preponderance of the evidence fails
to support the Examiner’s conclusion of obviousness as to claim 56.
In traversing this rejection, Appellant reiterates its arguments,
addressed above, against the Examiner’s rejection of claim 56 over the
combination of INSERM and McDade. See Appeal Br. 20–21. For the
reasons discussed above, we are not persuaded that the Examiner erred in
determining that the process of claim 56 would have been obvious in view of
INSERM and McDade.
Accordingly, we affirm the Examiner’s rejection of claim 56 over the
combination of Place, INSERM, and McDade. Claims 40–50, 54, 55, and
57–59 fall with claim 56. 37 C.F.R. § 41.37(c)(1)(iv).
OBVIOUSNESS—
PLACE, INSERM, MCDADE, AND MOHAMMED
Claims 51–53 depend directly or ultimately from claim 49, discussed
above. See Appeal Br. 25–26. In rejecting claims 51–53, the Examiner
cited Place, INSERM, and McDade for the teachings noted above, and cited
Mohammed as evidence that the additional elements recited in claims 51–53
would have been obvious features of the process suggested by the remaining
references. See Ans. 21–22.
In traversing this rejection, Appellant does not identify, nor do we
discern, specific error in the Examiner’s combination of Mohammed with
the other references. Rather, Appellant reiterates its arguments, addressed
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above, against the Examiner’s rejection of claim 49 over Place, INSERM,
and McDade. See Appeal Br. 21. For the reasons discussed above, we do
not find those arguments persuasive. Accordingly, we also affirm the
Examiner’s rejection of claims 51–53.

CONCLUSION
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
40, 41, 46 102(b) INSERM 40, 41, 46
56, 58, 59 103(a) INSERM, McDade 56, 58, 59
40–46, 49,
50, 54
103(a) Place, INSERM 40–46, 49,
50, 54
40–50,
54–59
103(a) Place, INSERM,
McDade
40–50, 54–59
51–53 103(a) Place, INSERM,
McDade,
Mohammed
51–53
Overall
Outcome
40–59

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

AFFIRMED