Eastman, Scott et al.

Patent Trials and Appeals Board

Oct 28, 2019

15282562 - (D) (P.T.A.B. Oct. 28, 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.
15/282,562 09/30/2016 Scott Eastman 11831.610US1 /
6100-01-1U
6625
157343 7590 10/28/2019
FisherBroyles, LLP - Myriad Genetics, Inc.
Victoria Brewster
555 Bryant St. #377
Palo Alto, CA 94301
EXAMINER
SHAFER, SHULAMITH H
ART UNIT PAPER NUMBER
1647
NOTIFICATION DATE DELIVERY MODE
10/28/2019 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
docketing@fisherbroyles.com
ipdept@myriad.com
victoria.brewster@fisherbroyles.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte SCOTT EASTMAN and ERIC SASSO
__________

Appeal 2019-003328
Application 15/282,5621
Technology Center 1600
__________

Before ULRIKE W. JENKS, RACHEL H. TOWNSEND, and
MICHAEL A. VALEK, Administrative Patent Judges.

TOWNSEND, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
for treating a subject having juvenile idiopathic arthritis, which have been
rejected as being directed to patent ineligible subject matter and as being
obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
Appellant’s Specification states that Juvenile Idiopathic Arthritis
(JIA) “is the most common rheumatic disease affecting children and

1 We use the word “Appellant” to refer to “Applicant” as defined in 37
C.F.R. § 1.42. Appellant, Crescendo Bioscience, which is a wholly owned
subsidiary of Myriad Genetics, Inc. identifies itself as the real party in
interest. (Appeal Br. 3.)
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adolescents.” (Spec. ¶ 4.) Appellant’s Specification also notes that
“[p]resentation, severity, and course of disease vary widely, from a benign
self-limiting course, to severe, unremitting disease resulting in progressive
joint destruction, skeletal deformity, growth retardation, possible blindness,
and long-term disability.” (Id.) The Specification further states that “[n]o
existing single biomarker or multi-biomarker test produces results
demonstrating a high association with level of JIA disease activity.” (Id.
¶ 7.) Appellant’s invention is directed at “using the biomarkers to measure
disease activity in a subject.” (Id. ¶ 8; see also ¶¶ 9–12, ¶ 35 (“The present
teachings relate generally to diagnostic applications of biomarkers
associated with subjects having inflammatory and/or autoimmune diseases,
such as for example JIA, and that are useful in determining or assessing
disease or flare activity.”).) The Specification does not provide for any
particular method of treatment for JIA other than to assess biomarkers prior
to any treatment. (Id. ¶ 12.)
Claims 1, 2, and 4–8 are on appeal.2 Claim 1 is representative and
reads as follows:
1. A method for treating a subject having juvenile idiopathic
arthritis (JIA) the method comprising:
providing a test sample comprising a sample of bodily
fluid taken from the mammal;
determining a sample concentration for a combination of
three or more biomarkers selected from the group comprising
C-reactive protein (CRP); epidermal growth factor (EGF);
interleukin 6 (IL-6); leptin (LEP); matrix metalloproteinase-1
(MMP1); matrix metalloproteinase-3 (MMP3); resistin

2 Claims 10–20 remain pending but are withdrawn from consideration as
being directed to a non-elected invention. (Final Action 2.)
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(RETN); serum amyloid (SAA); tumor necrosis factor receptor,
type 1 (TNF-R1); vascular cell adhesion molecule-1 (VCAM1);
vascular endothelial growth factor A (VEGF-A); and YKL-40;
determining whether the sample concentration is
statistically significantly greater than a combination of
concentrations of corresponding control biomarkers that are
indicative of JIA; and
administering a JIA therapeutic regimen if the sample
concentration is statistically significantly greater than the
combination of concentrations of corresponding control
biomarkers.
(Appeal Br. 18.)
The following grounds of rejection by the Examiner are before us on
review:
Claims 1, 2, and 4–8 under 35 U.S.C. § 101 as being directed to
patent-ineligible subject matter.
Claims 1, 2, 4–6, and 8 under 35 U.S.C. § 103(a) as unpatentable over
Cavet.3
Claim 7 under 35 U.S.C. § 103(a) as unpatentable over Cavet and
Shimizu.4
DISCUSSION
Patent Ineligible Subject Matter
The Examiner finds that claims 1, 2, and 4–8 are directed to a natural
law:

3 Cavet et al., US 2011/0137851 A1, published June 9, 2011.
4 Shimizu et al., Distinct subsets of patients with systemic juvenile
idiopathic arthritis based on their cytokine profiles, 61 Cytokine 345–348
(2013).
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The relationship between concentrations of IL-6, MMP-3 and
YKL-40, or a combination thereof, in a subject and the presence
or absence of JIA is a natural law.
(Final Action 5).
The Examiner notes that the method of treatment is dependent upon
the diagnostic steps of determining the concentrations of the biomarkers and
assessing whether the concentration is statistically significantly greater than
controls which are indicative of JIA. (Id.) The Examiner notes that methods
of determining these biomarkers in samples were known in the art. (Id. at 5–
6.)
The Examiner finds that no specific treatment protocol is recited in
the claims and that “[t]reatment after diagnosis is a routine and obvious step
in the medical arts; thus the claim, as amended, adds only a conventional
step [recited at a high degree of generality] and nothing significantly
different than the judicial exception.” (Id. at 6–7.)
Appellant does not argue the claims separately. We analyze claim 1
as representative. We agree with the Examiner’s factual findings and
conclusion that claim 1 is directed to patent ineligible subject matter.
35 U.S.C. § 101 defines patent-eligible subject matter. The Supreme
Court has carved out exceptions to what would otherwise appear to be
within the literal scope of § 101. Alice Corp. Pty. Ltd. v. CLS Bank Int’l,
573 U.S. 208, 216 (2014). One of these exceptions are claims “directed to”
laws of nature. Id. This appeal involves the law of nature exception to
patent eligibility under section 101.
The Supreme Court has established a two-step framework for
“distinguishing patents that claim laws of nature, natural phenomena, and
abstract ideas from those that claim patent-eligible applications of those
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concepts.” Id. at 217. “First, we determine whether the claims at issue are
directed to” a patent-ineligible concept. Id. If so, “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.” Id. (quoting Mayo Collaborative
Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 78–79 (2012)).
The United States Patent and Trademark Office (PTO) issued the
2019 Revised Patent Subject Matter Eligibility Guidance (“Guidance”),
indicating how the PTO would analyze patent eligibility under the Supreme
Court’s two-step framework. 84 Fed. Reg. 50–57 (January 7, 2019).
Applying the Guidance, we agree with the Examiner that the pending claims
are directed to patent ineligible subject matter.
STEP 2A, Prong One:
Under the Guidance, in determining what concept a claim is “directed
to” in step one of the Supreme Court’s two-step framework, we first look to
whether the claim recites any judicial exceptions, such as a law of nature.
Guidance, 84 Fed. Reg. at 52, 54 (Step 2A, Prong One).
In Mayo, the Supreme Court found that a claim was directed to a
natural law, where the claim required administering a drug and determining
the levels of a metabolite following administration, where the level of
metabolite was indicative of a need to increase or decrease the dosage of the
drug. Mayo, 566 U.S. at 74; Athena Diagnostics, Inc. v. Mayo Collaborative
Servs. LLC, 915 F.3d 743, 750, 753–54 (Fed. Cir. 2019) (noting that
detecting the presence of a label in a method for diagnosing
neurotransmission or developmental disorders related to MuSK comprising
contacting labeled MuSK with a bodily fluid, immunoprecipitating any
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antibody/MuSK labeled complex, monitoring for the label, and noting the
presence of the label is indicative of a neurotransmission or developmental
disorder related to MuSK, involves “the correlation between the presence of
naturally-occurring MuSK autoantibodies in bodily fluid and MuSK-related
neurological diseases” that “exists in nature apart from any human action.”).
Appellant does not dispute that claim 1 involves a natural law. (See,
e.g., Appeal Br. 8 (“Appellant submits that the claims under appeal are
patent eligible because the claims recite the application of a therapeutic
regimen.”).) The claim requires comparing the sample concentration
biomarkers against concentrations of corresponding control biomarkers that
are indicative of JIA and “determining whether the sample concentration is
statistically significantly greater” than the control and thus indicative of JIA
or not significantly greater and thus not indicative of JIA. This
“determining” step recites a natural law, i.e., the correlation between the
concentration of certain naturally occurring compounds, which are the
biomarkers, and the presence of JIA.
STEP 2A, Prong Two:
Having made the determination that claim 1 recites a natural law,
under the Guidance, we next examine whether there are additional elements
beyond the natural law that integrates the judicial exception into a practical
application. Under the Guidance, this is referred to as the “Prong Two”
inquiry under “Step 2A.” Guidance, 84 Fed. Reg. at 54–55. That is, under
the Prong Two analysis we look to whether the claim as a whole “appl[ies],
rel[ies] on, or use[s] the judicial exception in a manner that imposes a
meaningful limit on the judicial exception.” Id.
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The additional steps here include the data gathering to determine the
levels of biomarkers in a test sample and compare the levels to a control.
The Specification does not indicate any particular method of determining is
required; rather it explains that this determination can be done by
immunoassay or clinical chemistry to assess the presence and concentration
of the biomarkers. (Spec. ¶¶ 10, 11, 105.) The determination of the
statistical significance of the amount of the biomarker as compared to
control also is not required to be by a particular method. Many methods are
described in the Specification. (See, e.g., ¶¶ 72–78.) As our reviewing court
has explained application of “conventional techniques to detect [the] . . .
natural law” are not a particular application of the natural law. See Athena,
915 F.3d at 751. Similar to the “determining” step in Mayo, here the first
“determining” step tells the person performing the method to determine the
concentration of biomarkers through whatever process that person wishes to
use. See Mayo, 566 U.S. at 79. The second “determining” step, which is an
identification of the correlation, simply notes that a particular conclusion can
be drawn in light of the correlation: “rather like Einstein telling linear
accelerator operators about his basic law and then trusting them to use it
where relevant.” Id. at 78.
Limitations that are indicative of integration into a practical
application can include the particular application of a natural law to effect a
particular treatment or prophylaxis for a disease or medical condition. See,
e.g., VandaPharms. Inc. v. West-Ward Pharms. Int’l Ltd., 887 F.3d 1117,
1134–35 (Fed. Cir. 2018). While Appellant’s claim is purportedly a method
of treatment, as the Examiner explains, the method steps do not require that
a treatment be administered. (Ans. 9.) That is, “[t]he skilled artisan is
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directed to do nothing if the concentration of the combination of biomarkers
is not statistically significantly greater than a combination of control
biomarker concentrations.” (Id. at 10 (emphasis omitted).) In particular, the
claim requires “determining a sample concentration for a combination” of
particular biomarkers, and “determining whether the sample concentration is
statistically significantly greater than a combination of concentrations of
corresponding control biomarkers that are indicative of JIA.” The
administration of a JIA therapeutic regimen is only a required step “if the
sample concentration is statistically significantly greater than the
combination of concentrations of corresponding control biomarkers.”
(Appeal Br. 18 (Claim 9).) Consequently, under certain scenarios the
claimed method merely results in detection of the biomarker and no action is
to be taken based on the information ascertained in the detection of the
natural correlation. In other words, if a certain condition precedent is not
met, the additional step of administering a treatment is not performed.
Indeed, Appellant agrees that such is the case stating:
the appealed claims apply the relationship of the biomarker
expression levels by instructing a skilled artisan whether or not
to treat with a JIA therapeutic regimen based on whether the
sample concentration is statistically significantly greater than a
combination of control biomarker concentrations.
(Appeal Br. 9.)5

5 In its Reply Brief, Appellant contends that claim 1 does not encompass the
lack of treatment because the preamble of the claim states a “method for
treating.” (Reply Br. 3.) However, the preamble “expression does not result
in a manipulative difference in the steps of the claim” and is thus deemed to
be only a statement of purpose and intended result. Bristol-Myers Squibb
Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1376 (Fed. Cir. 2001).
Appellant’s additional argument in the Reply Brief that one of ordinary skill
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This is similar to claims in Ex parte Schulhauser, Appeal No. 2013-
007847 (PTAB Apr. 28, 2016) (precedential), where the Board concluded
that in a method claim where the additional steps need only be performed if
certain conditions precedent were met, the claim covered the method where
the additional steps need not be performed. We conclude that this principle
applies to claim 1 on appeal here. As such, like the claims found patent-
ineligible in Mayo, Appellant’s claim involves acquiring information to
observe the natural law, but do not require any particular use of the acquired
information to, e.g., alter a patient’s condition. Mayo, 566 U.S. at 79–80
(claims ineligible where they merely “tell doctors to gather data from which
they may draw an inference in light of the correlations”).
Appellant argues that “there is doubt that Schulhauser is readily
applied outside the ‘context of both method claims and system claims’ in the
electronic/mechanical arts.” (Reply Br. 5.) We disagree. The legal issue as
to the broadest reasonable construction of claims that include conditional
language addressed in Schulhauser is not limited by or to a particular
technology. The analysis is universally applicable: conditional limitations in
a method claim are not limiting under a broadest reasonable interpretation,
because the claim covers at least two possibilities—one in which the
condition is satisfied and one in which the condition is not satisfied.

in the art would interpret claim 1 at issue to encompass only treatment being
performed on confirmed high risk patients (Reply Br. 2–3) is belied by the
claim language which requires administration of a therapeutic only “if the
sample concentration is statistically significantly greater than the
combination of concentrations of corresponding control biomarkers.”
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Second and apart from the fact that treatment is not always required
by the claim, to the extent treatment is administered because “the sample
concentration is statistically significantly greater than the combination of
concentrations of corresponding control biomarkers,” there is no particular
treatment required. The Guidance suggests that a claim including “an
additional element that applies or uses a judicial exception to effect a
particular treatment or prophylaxis for a disease or medical condition”
would be a practical application. Guidance, 84 Fed. Reg. at 55 (citing
Classen Immunotherapies, Inc. v. Biogen IDEC, 659F.3d 1057, 1066–68
(Fed. Cir. 2011); and Vanda, 887 F.3d at 1135) (emphasis added). On the
other hand, the Guidance also suggests that a claim including “[a]n
additional element [that] merely recites the words ‘apply it’ (or an
equivalent) with the judicial exception,” does not integrate the judicial
exception into a practical application. Id. (citing Alice, 573 U.S. at 222–26;
Gottschalk v. Benson, 409 U.S. 63 (1972); and Credit Acceptance Corp. v.
Westlake Servs., 859 F.3d 1044 (Fed. Cir. 2017). See also Mayo, 566 U.S. at
72, 81 (claiming a law of nature or natural phenomenon and also reciting
steps that must be taken to apply the laws in question is not patent-eligible);
October 2019 Update: Subject Matter Eligibility at 14 (October 18, 2019),
available at https://www.uspto.gov/sites/default/files/documents/
peg_oct_2019_update.pdf (“October 2019 Guidance Update”).
Here, the claim says to administer a JIA therapeutic regimen “if the
sample concentration is statistically significantly greater than the
combination of concentrations of corresponding control biomarkers.” That
language, on its face, does not require the use or application of the natural
law to effect the therapeutic regimen chosen. And even if the claim were
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interpreted to recite a regimen based on the natural correlation between the
markers and JIA, the administering step is stated at such a high level of
generality, we conclude that it is merely the equivalent of an instruction to
apply it. Thus, claim 1 does not apply or use the natural correlation to
“effect a particular treatment or prophylaxis.” See October 2019 Guidance
Update at 14.
The level of generality stands in contrast to the claims found patent-
eligible in cases like Vanda and Natural Alternatives Int’l v. Creative
Compounds LLC, 918 F.3d 1338, 1345 (Fed. Cir. 2019). The claims at issue
in Vanda that were found not to be directed to a law of nature, but to a
method of treatment, required performing one of two specific therapies for
schizophrenia with specific daily doses of iloperidone based on a patient’s
genetic disposition. Id. at 1134 (holding that claims including a limitation of
genotyping to determine if a patient is a CYP2D6 poor metabolizer and then
administering a drug in either case but in certain amounts depending upon
whether the patient is or is not a CYP2D6 poor metabolizer). The Federal
Circuit characterized the Vanda claims as being directed to “a specific
method of treatment for specific patients using a specific compound at
specific doses to achieve a specific outcome.” Vanda, 887 F.3d at 1136.
In Natural Alternatives, the Federal Circuit explained that the method
claims at issue “contain a dosage limitation by virtue of the ‘effective’
limitation” and
[t]he claims not only embody this discovery [that administering
certain quantities of beta-alanine to a human subject alters that
subject's natural state to produce greater levels of creatine
which results in specific physiological benefits for athletes
engaged in certain intensive exercise,] they require that an
infringer actually administer the dosage form claimed in the
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manner claimed, altering the athlete’s physiology to provide the
described benefits.
918 F.3d at 1344, 1346. Appellant’s claim 1 is not directed to a specific
method of treatment using a specific compound at a specific dose based on
the natural law. Thus, the claimed method is not a practical application of
the natural law.
Furthermore, we find, as the Examiner did, that considering the steps
of claim 1 together as an ordered combination adds nothing to the law of
nature that is not already present when the steps are considered separately.
We conclude, therefore, that the claims do not recite additional elements that
integrate the exception into a practical application of that exception. The
process steps here merely tell those “interested in the subject about the
correlations that the researchers discovered.” Mayo, 566 U.S. at 78.
STEP 2B
Step 2B requires that we look to whether the claim “adds a specific
limitation beyond the judicial exception that [is] not ‘well-understood,
routine, conventional’ in the field.” (See MPEP § 2106.05(d) (9th ed., rev.
08.2017 (Jan. 2018)).). The Examiner found, and Appellant does not
dispute, that determining the concentrations of the biomarkers at issue in
samples was known in the art. (Final Action at 5–6 (citing references).) The
Examiner further found, and Appellant does not dispute, that “[t]reatment
after diagnosis is a routine and obvious step in the medical arts.” (Id. at 6.)
Based on the foregoing, therefore, we conclude that claim 1 is
directed to a judicial exception without significantly more, and therefore, is
not eligible for patent protection.
Claims 2 and 4–8 have not been argued separately and therefore fall
with claim 1. 37 C.F.R. § 41.37(c)(1)(iv) (2017).
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II
Non-Obviousness
In response to a restriction requirement, Appellant elected the
biomarkers IL6, MMP3, and YKL-40 for examination. (Final Action 2.)
The Examiner finds that Cavet teaches a method of measuring inflammatory
disease activity by measuring the levels of at least two biomarkers, including
IL6, MMP3, and YKL-40, in a sample and comparing the levels to
constituent levels of those markers in samples and making a clinical
assessment thereon. (Id. at 9.) The Examiner explains that “[t]he disease
activity to be measured may include juvenile idiopathic arthritis [paragraph
0105].” (Id.) The Examiner also finds that Cavet teaches that using multiple
serum biomarkers “are necessary for the accurate clinical assessment of
disease activity in subjects [paragraph 0014].” (Id.) The Examiner further
finds that
[t]he reference discloses that measurement of the biomarkers
would aid in accurately classifying subjects by disease activity,
in order to establish their optimal treatment regimen [paragraph
0009], thus suggesting a therapeutic regimen would follow
diagnosis of JIA.
(Id.) The Examiner concludes that one of ordinary skill in the art would
have found it obvious to modify Cavet to include assaying for the elected
biomarkers with a reasonable expectation of success “because the reference
teaches that such a method is successful in diagnosing an inflammatory
disease such as JIA, and one would be aware that measuring additional
biomarkers would provide useful diagnostic information.” (Id. at 10.)
The Examiner further explains that while the “[e]xamples presented
deal with diagnosis and treatment of rheumatoid arthritis” (RA), the art
demonstrates that the symptoms presented in JIA and RA are similar and the
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treatment regimens (including NSAID therapy and methotrexate) are similar.
(Ans. 15–17.) Thus, according to the Examiner “one of ordinary skill, aware
of the success in utilizing the markers to diagnose and plan a treatment
regimen to treat rheumatoid arthritis, would be motivated to apply methods
taught by Cavet to diagnose and treat JIA.” (Id. at 17.)
Appellant argues that Cavet mentions JIA once in a paragraph
defining autoimmune disease where JIA is mentioned as one of thirty-seven
autoimmune disorders, and does not “describe[] any sort of success in
diagnosing an inflammatory disease or even administering a JIA
therapeutic.” (Appeal Br. 13.) Appellant further argues that “Cavet does not
describe the use of the recited biomarkers to identify individuals with JIA.”
(Id. at 15.) Thus, according to Appellant “[t]here is simply no indication
whatsoever, not even in the definition of an autoimmune disorder in Cavet,
that indicates to a skilled artisan any success of the presently claimed
invention.” (Id. at 13.) Appellant further explains that the prior art
references the Examiner cites to for establishing the similarity of JIA and
RA do not “provide knowledge sufficient to select particular biomarkers
disclosed in Cavet, which are used for RA, to be used in a method for
treating JIA.” (Reply Br. 7.) The Appellant argues that the similarity of
symptoms and treatment therapeutics does not help to predict a priori a
specific group of biomarkers from Cavet that would be useful in identifying
JIA and treating that inflammatory disease. (Id. at 7–8.) In particular,
Appellant notes that “NSAIDS, which include aspirin and ibuprofen, are
also used as analgesics and antipyretics, and methotrexate is also used for
psoriasis” which Appellant urges establishes that the “superficial level of
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fact finding does not predict a biomarker solution and does not justify prima
facie obviousness.” (Id. at 9.)
We agree with Appellant that the Examiner has failed to establish a
prima facie case of obviousness as to the elected invention. We agree with
the Examiner that Cavet is not limited to its preferred embodiment (Ans. 14–
15), which includes methods of diagnosing RA disease activity so as to
provide appropriate and optimized treatment for patients (Cavet ¶¶ 4, 9, 14).
However, we agree with the Appellant that the mere similarity of symptoms
of disease and overlap of treatment modalities does not establish a
reasonable expectation of selecting the specific biomarkers claimed as
relevant to an assessment of JIA. (Appeal Br. 7–8.)
That is because Cavet teaches that, even as to RA,
[d]eveloping biomarker-based tests (e.g., measuring cytokines),
e.g. specific to the clinical assessment of RA, has proved
difficult in practice because of the complexity of RA biology—
the various molecular pathways involved and the intersection of
autoimmune dysregulation and inflammatory response.
(Cavet ¶ 13.) The Examiner has not established with any evidence that RA
and JIA, which both involve arthritic conditions with autoimmune etiologies
or components (Ans. 15), share any of the same or similar biochemical
pathways in their autoimmune dysregulation and inflammatory response.
Cavet only discloses that the DAIMRK group of biomarkers is a set of
biomarkers that is “strongly associated with inflammatory disease, and
especially RA, when used in particular combinations.” (Cavet ¶ 174.)
Moreover, regarding the “Biological Significance of the DAIMRK Group of
Markers,” Cavet teaches that
[t]he methodology employed in selecting the DAIMRK
biomarkers thus resulted in a set of markers especially useful in
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quantifying RA disease activity, by providing the clinician with
a unique and broad look at RA disease biology.
(Id. ¶ 177.) And, while a diversity of pathways are represented, that
diversity is relevant to RA and “the clinical assessment of individual
subjects, despite the heterogeneity of the pathology of the disease assessed.”
(Id. ¶ 176.) In other words, the DAIMRK biomarkers are specific to RA and
there is no teaching of how one of ordinary skill in the art would know
which of those markers would reasonably correlate to JIA. While it may be
the case that one of ordinary skill in the art could have used the “Model
Development Process” described in Cavet (id. ¶¶ 181–188) to assess what
biomarkers are relevant to JIA, that the described process would be
promising to try does not establish obviousness. In re Kubin, 561 F.3d
1351, 1359 (Fed. Cir. 2009) (identifying two categories of obvious-to-try
situations that do not equate to prima facie obviousness under § 103: when
what was “obvious to try” was (a) to vary all parameters or try every
available option until one succeeds, where the prior art gave no indication of
critical parameters and no direction as to which of many possibilities is
likely to be successful; or (b) to explore a new technology or general
approach in a seemingly promising field of experimentation, where the prior
art gave only general guidance as to the particular form or method of
achieving the claimed invention.); In re Eli Lilly & Co., 902 F.2d 943, 945
(Fed. Cir. 1990) (“An ‘obvious-to-try’ situation exists when a general
disclosure may pique the scientist’s curiosity, such that further investigation
might be done as a result of the disclosure, but the disclosure itself does not
contain a sufficient teaching of how to obtain the desired result, or that the
claimed result would be obtained if certain directions were pursued.”).
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There is no particular combination of disclosed biological markers in
Cavet that is noted to be associated with JIA. Picking one of a finite number
of known solutions to a known problem is obvious. KSR Int’l Co. v. Teleflex
Inc., 550 U.S. 398, 421 (2007): That is not the case here. Consequently,
even though Cavet generically suggests a genus of biomarkers from the
DAIMRK biomarkers from which to select at least two biomarkers in a
diagnostic method for inflammatory disease that completely overlaps the
biomarkers claimed (Cavet ¶¶ 15, 19), we do not agree with the Examiner
that Cavet provides a reasonable expectation that any combination of these
biomarkers or any other biomarkers from the DAIMRK genus would
reasonably be expected to have a correlation to diagnosing JIA.
Thus, we reverse the Examiner’s rejection of claims 1, 2, 4–6, and 8
as being obvious over Cavet.
The Examiner’s rejection of claim 7 over Cavet and Shimizu does not
rectify the problem discussed above regarding claim 1. Thus, we also
reverse the Examiner’s rejection of claim 7 as being obvious over Cavet and
Shimizu.
CONCLUSION
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1, 2, and 4–
8
101 Eligibility 1, 2, and 4–
8

1, 2, 4–6,
and 8
103 Cavet 1, 2, 4–6,
and 8
7 103 Cavet and Shimizu 7
Overall
Outcome
1, 2, and 4–
8

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TIME PERIOD FOR RESPONSE
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