Martin Leonard. Ashdown et al.

Patent Trials and Appeals Board

Jul 24, 2019

14579487 - (D) (P.T.A.B. Jul. 24, 2019)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
14/579,487 12/22/2014 Martin Leonard Ashdown 8651-4-PUS-1 9353
22442 7590 07/24/2019
Sheridan Ross PC
1560 Broadway
Suite 1200
Denver, CO 80202
EXAMINER
HALVORSON, MARK
ART UNIT PAPER NUMBER
1642
NOTIFICATION DATE DELIVERY MODE
07/24/2019 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):
e-docket@sheridanross.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte MARTIN LEONARD ASHDOWN and MARIA LUISA
ASHDOWN
____________

Appeal 2018-006466
Application 14/579,4871
Technology Center 1600
____________

Before JEFFREY N. FREDMAN, TAWEN CHANG, and DAVID COTTA,
Administrative Patent Judges.

COTTA, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134 involving claims to a method
of detecting the dynamics of immune system cycling in a patient having an
autoimmune disease. The Examiner rejected the claims on appeal under
35 U.S.C. § 101 as directed to patent ineligible subject matter and under
35 U.S.C. § 103(a) as obvious. We affirm the rejection under 35 U.S.C. §
101, reverse the rejection under 35 U.S.C. § 103(a), and enter a new ground
of rejection under 35 U.S.C. § 103(a).

1 According to Appellants, the real party in interest is Biotempus Pty. Ltd.
App. Br. 3. Appellants identify this case as related to Appeal No. 2018-
000527. Id. at 4.
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STATEMENT OF THE CASE
The Specification discloses that “[n]umerous diseases have been
linked to the production of effector cells.” Spec. 1. The Specification states
that “[t]he present inventors have surprisingly found that both effector cell
and regulator cell numbers cycle during disease states characterized by the
presence of effector cells.” Id. at 5. According to the Specification, “[t]his
cycling occurs on a regular basis, with effector cell expansion against a
target antigen being followed by the expansion of regulator cells directed
against the effectors.” Id. “Upon control of the effector cells by the
regulator cells the numbers of both types of cells decrease, which in turn is
followed by the same cycle due to the continuous presence of antigen.” Id.
at 5–6. The Specification discloses:
Knowledge of this cycle can be used to treat diseases where it is
known that the emergence of effector cells is detrimental to the
patient. Examples of such conditions are autoimmune diseases
and transplantation rejection. More specifically, treatment of a
patient can be timed such that effector cell expansion does not
occur, and/or effector cell numbers are reduced or abolished.
Id. at 6.
Appellants’ alleged invention “relates to the realization that effector
cells numbers are cycling in” “diseases . . . linked to the production of
effector cells” and that “regulator cells are cycling in degenerative diseases.”
Id. at 1. “Based on these realizations, the present invention provides
methods for treating conditions such as autoimmune diseases, degenerative
diseases, and graft-versus-host disease.” Id. at 1. Appellants’ invention also
“relates to methods of determining when therapy should be administered to a
patient.” Id.
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Claims 67–76 and 78–80 are on appeal. Claim 67 is illustrative and
reads as follows:
67. A method of detecting the dynamics of immune system
cycling in a patient having an autoimmune disease comprising:
a) selecting a patient having an autoimmune disease but
not having an infection,
b) obtaining multiple samples from the patient at a
frequency of at least one sample every three days, and
c) detecting the dynamics of immune system cycling in
the patient by assaying each of the multiple samples for the
levels of the one or more immune system marker(s).
App. Br. 34 (Claims App.). During prosecution, in response to a
requirement to elect a species, Appellants elected c-reactive protein (“CRP”)
as the claimed immune system marker. Ans. 14. We limit our discussion
and consideration to the elected species, and take no position respecting the
patentability of the broader generic claims, including the remaining, non-
elected species. See Ex parte Ohsaka, 2 USPQ2d 1460, 1461 (BPAI Mar.
31, 1987).
The claims stand rejected as follows.
Claims 67–76, 78, and 79 were rejected under 35 U.S.C. § 101 as
directed to patent ineligible subject matter.
Claims 67–76, 78, and 79 were rejected under 35 U.S.C. § 103(a) as
obvious over the combination of Schwenger2 and Weirich.3

2 Schwenger et al, CRP Levels in Autoimmune Disease Can be Specified by
Measurement of Procalcitonin, 26 Infection 274–276 (1998) (“Schwenger”).
3 Weirich et al., US Patent No. 6,077,665, issued June 20, 2000 (“Weirich”).
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CLAIM CONSTRUCTION
We begin by construing the claims. During prosecution before the
PTO, claim terms are given their broadest reasonable interpretation
consistent with the specification, reading claim language in light of the
specification as it would be interpreted by one of ordinary skill in the art. In
re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004).
Claim 67 requires “obtaining multiple samples from the patient at a
frequency of at least one sample every three days.” This language presents
the question: Does this limitation establish a minimum sampling frequency,
such that the claim can be met by e.g., obtaining samples more frequently
than once every three days, or does it instead establish a minimum interval
between sampling, such that at least one of the multiple samples must be
obtained three days after another sample was obtained? We find that the
limitation establishes a minimum sampling frequency that can be met by
obtaining multiple samples within a three day period.
Our construction is supported by the teaching in the Specification that
it is important to monitor the patient as frequently as possible. The
Specification states:
Furthermore, it is preferred that the patient is monitored
as frequently as possible to ensure immune system cycling
within a given patient is suitably characterized. Naturally this
will ensure that the agent is administered at the appropriate time
and that any small variations in, for example, effector/regulator
cell numbers or activity, or markers thereof, is not
misinterpreted. Preferably, the patient is monitored at least
every 3 days, more preferably at least every 2 days, and most
preferably at least every day. Monitoring may occur more
frequently, for instance every 12 hours, when the cycling is
reaching a stage where it is likely that the timing would be
appropriate to administer the agent.
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Spec. 15. This passage suggests that monitoring “at least every 3 days” is a
minimum sampling frequency and that the limitation can be met by
obtaining samples more frequently. This interpretation is consistent with
dependent claims 72–74, each of which narrows claim 67 by specifying a
more frequent sampling frequency. For example, claim 74, the narrowest of
these claims, requires that “the step of assaying4 comprises assaying at least
one sample every twelve hours.” This suggests that the broader limitation
“at least one sample every three days” can be met by sampling more
frequently – e.g., by sampling every twelve hours. Claim 67.
We acknowledge that the Specification also teaches that patients need
to be monitored for an extended period of time in order to properly assess
their immune system cycle. See, e.g., Spec. 13–14 (“As result, it will most
likely be desirable to monitor the patient for a sufficient length of time to
follow trends in fluctuations between and within cycles, and hence sufficient
to determine the maximum and/or minimum, whichever is required for the
relevant cell type, or marker thereof. This ensures that the dynamics of the
immune system cycling within a particular patient is understood.”).
However, given the Specification’s teachings regarding the importance of
frequent sampling, and the fact that dependent claims 72–74 narrow claim
67 by requiring more frequent sampling, we find that the limitation “at least

4 Claims 72–74 narrow the “assaying” step recited in claim 67; however, in
context, it appears that these claims were intended to instead narrow the
“obtaining” step because the import of the limitation is how frequently
samples are obtained rather than how frequently assays on the samples as
performed. For purposes of this opinion, we treat claims 72–74 as
narrowing the “obtaining” step.
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one sample every three days” is best understood as a minimum sampling
frequency.
Claim 67 also requires “detecting the dynamics of immune system
cycling in the patient.” The Examiner interpreted this phrase to require
“comparing and correlating the levels of the immune system markers over
time to obtain the relationship of the immune system marker over time in a
patient with an autoimmune disease.” Ans. 7. This interpretation is
consistent with the way the claimed method is described in the Specification.
See, e.g., Spec. 5–6 (“The present inventors have surprisingly found that
effector cell and regulator cell numbers cycle during disease states
characterized by the presence of effector cells. . . . Knowledge of this cycle
can be used to treat diseases where it is known that the emergence of
effector cells is detrimental to the patient.”). Accordingly, we construe the
phrase “detecting the dynamics of immune system cycling” to require
analyzing samples to determine the length of the patient’s immune system
cycle.
OBVIOUSNESS OVER SCHWENGER AND WEIRICH
In finding claim 67 and the claims depending therefrom, the Examiner
found that Schwenger disclosed measuring CRP levels in patients with an
autoimmune disease. Ans. 14. The Examiner also found that Schwenger
disclosed that patients with autoimmune disease are prone to infection and
that CRP levels provide a sensitive indication of infection. Id. The
Examiner found that Weirich disclosed measuring amounts of CRP over a
period of days to monitor infections. Id. Based on the disclosures of
Schwenger and Weirich, the Examiner concluded that the ordinary artisan
“would have been motivated to apply Weirich’s CRP-measuring regimen to
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Schwenger’s method for measuring CRP levels in patients with autoimmune
disorders because both Weirich and Schwenger disclose methods for
measuring CRP levels to detect bacterial infections.” Id. The Examiner
found that it would have been “obvious to combine Schwenger’s method for
measuring CRP levels in patients with autoimmune disease with Weirich’s
CRP-measuring regimen to have a method of assaying multiple samples
from the patient for the level of CRP in each of the samples at a frequency of
at least one sample every three days.” Id. at 14–15.
Appellants argue that “neither reference identifies any need or reason
for measuring CRP levels in an autoimmune disease patient who does not
have an infection and obtaining samples more frequently from such a
patient.” App. Br. 28–29.
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.” Appellants have persuaded us that the Examiner has not
carried the burden of establishing that the claimed invention would have
been obvious over the cited art.
The Examiner finds a reason to combine the teachings of Schwenger
and Weirich to arrive at the claimed method in the desire of the ordinary
artisan to “measur[e] CRP levels to detect bacterial infections.” Ans. 14; see
also, November 20, 2017 Advisory Action 6 (“Thus, it would have been
obvious to obtain multiple samples at a high frequency from an autoimmune
patient if there is a suspected infection. Thus, the frequency of sampling
would increase when there is evidence of an infection and even to monitor
the progress of the infection during treatment. Thus, in view of Schwenger
and Weirich it would have been obvious to substitute the sampling regimen
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of Weirich for Schwenger’s regimen when there is evidence of an infection
in the autoimmune patients of Schwenger.”) (emphasis added). However,
claim 67 requires, “selecting a patient . . . not having an infection.” The
Examiner does not provide a persuasive explanation of how the combination
of Schwenger and Weirich would result in a method where CRP levels are
monitored in patients “not having an infection.”
In a November 20, 2017 Advisory Action, the Examiner reasoned that
the skilled artisan would measure CRP levels in patients who do not have a
bacterial infection to establish a baseline. The Examiner explained:
As stated by Applicant, infections cause an increase in the
immune system markers. Thus, selecting the autoimmune
patient when that patient does not have a bacterial infection
would be essential to monitor that patient for future infections.
This would allow for a baseline determination of CRP levels.
By monitoring CRP levels afterwards one could determine the
likelihood that the autoimmune patient has a bacterial infection.
Advisory Action, 5. Appellants dispute that it would be necessary to obtain
a baseline to monitor for infection. App. Br. 28 (“the suggestion by the
Examiner that selecting the autoimmune patient when that patient does not
have a bacterial infection to establish a base line would be essential to
monitor that patient for future infections, is without substance and shows a
lack of understanding in the art.”). Neither the Examiner nor Appellants
identify evidence to support their position as to the desirability of making a
determination of baseline CRP levels for purposes of monitoring an
infection. See, Johnston v. IVAC Corp., 885 F.2d 1574, 1581 (Fed. Cir.
1989) (“Attorneys’ argument is no substitute for evidence.”); In re Pearson,
494 F.2d 1399, 1405 (CCPA 1974). Absent evidentiary support, the
Examiner has not persuaded us that it would have been obvious to make a
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determination of baseline CRP levels for purposes of monitoring an
infection.
In addition, we note that the Examiner’s determination that it would
have been obvious to use systematic testing of CRP levels to detect
infections in Schwenger’s autoimmune patients appears to be at odds with
Schwenger’s teaching that “[o]n the basis of CRP levels an infections origin
could not be discriminated from an inflammatory response to disease
activity.” Schwenger 275; see also, id. at 276 (stating that “the classical
laboratory tests such as ESR, leukocytosis and serology, particularly CRP,
are often misleading because they are affected by both the response to
immunological reaction and the infection”).
Because the Examiner has not provided a persuasive reason to
combine the teachings of Schwenger and Weirich to arrive at a method of
repeatedly measuring CRP levels in autoimmune patients not having an
infection, we reverse the Examiner’s rejection of claim 67–76, 78, and 79 as
obvious over the combination of Schwenger and Weirich.

NEW GROUND OF REJECTION
Under the provisions of 37 C.F.R. § 41.50(b), we enter the following
new ground of rejection5 based substantially on the Examiner’s analysis in
the related application 14/063,104 that we affirmed in Appeal 2018-000527.

5 We limit our consideration to the claim 67. We leave it up to the Examiner
to consider the remaining claims in light of the cited prior art and other prior
art. The PTAB serves as a board of review, not a de novo examination
tribunal. See 35 U.S.C. § 6(b).
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Claim 67 is rejected under 35 U.S.C. § 103(a) as obvious over
Cohen.6
Cohen discloses methods and compositions for treating immune
system diseases. Cohen ¶ 3. Cohen teaches that “elevated levels of C-
reactive protein (CRP)” “correlate with rheumatoid arthritis” and that “[t]he
level of serum C-reactive protein . . . correlates with disease activity and the
likelihood of progressive joint damage.” Id. ¶ 7. Cohen discloses measuring
for baseline levels of CRP in autoimmune patients prior to treatment. Cohen
¶ 390 (“Patients were evaluated for baseline symptoms of disease activity
prior to receiving any infusions. . . . [T]he baseline evaluations included . . .
serum levels of C-reactive protein (CRP)”); see also, id. ¶ 138. As discussed
in the related appeal, a baseline is “a set of data collected at the beginning of
a study or before intervention has occurred” (see, The Free Dictionary by
Farlex, https://medical-dictionary.thefree dictionary.com/Baseline, last
accessed July 5, 2019), and thus establishing a baseline would involve
assaying multiple samples from a patient.
We find that Cohen anticipates and/or renders obvious the claimed
method. With respect to the first method step, “selecting a patient having an
autoimmune disease but not having an infection,” Cohen discloses
measuring CRP levels in patients with an autoimmune disease. Id. ¶ 390.
Cohen does not specify that the patients are free of infection. However,
absent a teaching that the patients have an infection, we infer that they are
not infected. Moreover, even if the patients in Cohen are not free of
infection, it would have been obvious to measure CRP levels in autoimmune

6 Cohen et al., US Patent Publication No. 2004/0022787 A1, published Feb.
5, 2004 (“Cohen”).
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patients free of infection because Cohen uses CRP levels to measure the
progression of the autoimmune disease, and not to detect infection.
With respect to the second method step, “obtaining multiple samples
from the patient at a frequency of at least one sample every three days,” we
find that taking multiple samples substantially contemporaneously – as
would be done to establish a baseline – meets the limitation requiring
obtaining “at least one sample every three days.”
With respect to the final method step, “detecting the dynamics of
immune system cycling in the patient by assaying each of the multiple
samples for the levels of the one or more immune system marker(s),” as
discussed above, we interpret this limitation to require analyzing samples to
determine the length of a patient’s immune system cycle. Perceiving or
calculating the length of the cycle is a mental step and, as such, is not
accorded patentable weight in an obviousness analysis. Praxair
Distribution, Inc. v. Mallinckrodt Hospital Products IP Ltd., 890 F.3d 1024,
1033 (Fed. Cir. 2018) (rejecting argument that consideration of whether
claims were directed to mental steps applied only in evaluating patent
eligibility, not obviousness, explaining, “[b]ecause claim limitations directed
to mental steps may attempt to capture informational content, they may be
considered printed matter lacking patentable weight in an obviousness
analysis.”).
A limitation that recites a mental step will be accorded patentable
weight only if the limitation has a “functional relationship to the rest of the
claim.” Id. at 1035 (“By interrelating the claimed information . . . with the
concrete step of discontinuing treatment because of the information, . . . the
printed matter . . . has a functional relationship to the rest of the claim and
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. . . patentable weight.”). We do not find such a functional relationship
between the mental step at issue and the remaining claim limitations.
Accordingly, we reject claim 67 as anticipated by and/or obvious over
Cohen. We leave it up to the Examiner to consider the remaining claims in
light of the cited prior art and other prior art.

PATENT ELIGIBLE SUBJECT MATTER
Appellants argue claims 67–76, 78, and 79 together. We designate
claim 67 as representative.
An invention is patent-eligible if it claims a “new and useful process,
machine, manufacture, or composition of matter.” 35 U.S.C. § 101.
However, the Supreme Court has long interpreted 35 U.S.C. § 101 to include
implicit exceptions: “[l]aws of nature, natural phenomena, and abstract
ideas” are not patentable. E.g., Alice Corp. v. CLS Bank Int’l, 573 U.S. 208,
216 (2014).
In determining whether a claim falls within an excluded category, we
are guided by the Supreme Court’s two-step framework, described in Mayo
and Alice. Id. at 217–18 (citing Mayo Collaborative Servs. v. Prometheus
Labs., Inc., 566 U.S. 66, 75–77 (2012)). In accordance with that framework,
we first determine what concept the claim is “directed to.” See Alice, 573
U.S. at 219 (“On their face, the claims before us are drawn to the concept of
intermediated settlement, i.e., the use of a third party to mitigate settlement
risk.”); see also Bilski v. Kappos, 561 U.S. 593, 611 (2010) (“Claims 1 and 4
in petitioners’ application explain the basic concept of hedging, or protecting
against risk.”).
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Concepts determined to be abstract ideas, and thus patent ineligible,
include certain methods of organizing human activity, such as fundamental
economic practices (Alice, 573 U.S. at 219–20; Bilski, 561 U.S. at 611);
mathematical formulas (Parker v. Flook, 437 U.S. 584, 594–95 (1978)); and
mental processes (Gottschalk v. Benson, 409 U.S. 63, 69 (1972)). Concepts
determined to be patent eligible include physical and chemical processes,
such as “molding rubber products” (Diamond v. Diehr, 450 U.S. 175, 192
(1981)); “tanning, dyeing, making water-proof cloth, vulcanizing India
rubber, smelting ores” (id. at 182 n.7 (quoting Corning v. Burden, 56 U.S.
252, 267–68 (1853))); and manufacturing flour (Benson, 409 U.S. at 69
(citing Cochrane v. Deener, 94 U.S. 780, 785 (1876))).
In Diehr, the claim at issue recited a mathematical formula, but the
Supreme Court held that “[a] claim drawn to subject matter otherwise
statutory does not become nonstatutory simply because it uses a
mathematical formula.” Diehr, 450 U.S. at 176; see also id. at 191 (“We
view respondents’ claims as nothing more than a process for molding rubber
products and not as an attempt to patent a mathematical formula.”). Having
said that, the Supreme Court also indicated that a claim “seeking patent
protection for that formula in the abstract . . . is not accorded the protection
of our patent laws, . . . and this principle cannot be circumvented by
attempting to limit the use of the formula to a particular technological
environment.” Id. (citing Benson and Flook); see, e.g., id. at 187 (“It is now
commonplace that an application of a law of nature or mathematical formula
to a known structure or process may well be deserving of patent
protection.”).
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If the claim is “directed to” an abstract idea, we turn to the second
step of the Alice and Mayo framework, where “we must examine the
elements of the claim to determine whether it contains an ‘inventive
concept’ sufficient to ‘transform’ the claimed abstract idea into a patent-
eligible application.” Alice, 573 U.S. at 221 (quotation marks omitted). “A
claim that recites an abstract idea must include ‘additional features’ to
ensure ‘that the [claim] is more than a drafting effort designed to
monopolize the [abstract idea].’” Id. (quoting Mayo, 566 U.S. at 77).
“[M]erely requir[ing] generic computer implementation[] fail[s] to transform
that abstract idea into a patent-eligible invention.” Id.
The PTO recently published revised guidance on the application of
§ 101. USPTO’s January 7, 2019, Memorandum, 2019 Revised Patent
Subject Matter Eligibility Guidance (“Memorandum”). Under that
guidance, we first look to whether the claim recites:
(1) any judicial exceptions, including certain groupings of abstract
ideas (i.e., mathematical concepts, certain methods of organizing
human activity such as a fundamental economic practice, or mental
processes); and
(2) additional elements that integrate the judicial exception into a
practical application (see MPEP § 2106.05(a)–(c), (e)–(h)).
Only if a claim (1) recites a judicial exception and (2) does not integrate that
exception into a practical application, do we then look to whether the claim:
(3) adds a specific limitation beyond the judicial exception that is not
“well-understood, routine, conventional” in the field (see MPEP
§ 2106.05(d)); or
(4) simply appends well-understood, routine, conventional activities
previously known to the industry, specified at a high level of
generality, to the judicial exception.
See Memorandum.
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A. Claim 67 Recites a Judicial Exception
Following the Guidance, we begin by considering whether claim 67
recites a judicial exception. In rejecting claim 67 as directed to patent
ineligible subject matter, the Examiner found that the claim was focused on
“a natural phenomenon, the levels of immune system markers in
autoimmune patients over time.” Ans. 3. The Examiner also found that the
method step of “detecting the dynamics of immune system cycling in the
patient” was an abstract idea. Ans. 4. We agree with the Examiner that
claim 67 recites a judicial exception.
Consistent with Mayo, the Guidance expressly identifies mental
processes – i.e., “concepts performed in the human mind (including an
observation, evaluation, judgment, opinion)” – as judicial exceptions. See,
Memorandum; Mayo, 566 U.S. at 71 (citation omitted) (“‘[M]ental
processes[ ] and abstract intellectual concepts are not patentable, as they are
the basic tools of scientific and technological work’”).
Claim 67 recites a method of “detecting the dynamics of immune
system cycling in a patient.” This phrase appears both in the preamble and
in method step (c). As discussed above, we construe the phrase “detecting
the dynamics of immune system cycling” to require analyzing samples to
determine the patient’s immune system cycle. This is a step that can be
performed mentally. It requires nothing more than thinking about and/or
observing the data obtained from assays. Accordingly, we conclude that
claim 67 recites concepts performed in the human mind, which is one of the
mental processes identified in the Guidance, and thus an abstract idea.
Additionally, claim 67 step (c), “detecting the dynamics of immune system
cycling in the patient by assaying each of the multiple samples for the levels
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of [CRP]” recites a natural law, i.e., the natural correlation between changes
in CRP level and immune system cycling.
Appellants argue that “‘detecting the dynamics of immune system
cycling in the patient’ cannot be considered an abstract idea” because it “is
not something that can be done merely by thought and is not merely
manipulation of information.” App. Br. 12. Instead, according to
Appellants, “it requires testing for and quantification of molecules that are
present in biological samples over time.” Id. at 12.
We do not dispute that in order to detect the dynamics of immune
system cycling one needs first to obtain data to analyze. However, in this
case, the focus of the claims is on the method of detecting the dynamics of
immune system cycling – the analysis – rather than on the data gathering
steps that precede the analysis. See Athena Diagnostics, Inc. v. Mayo
Collaborative Services LLC, 915 F.3d 743 (Fed. Cir. 2019) (finding that
method for diagnosing neurotransmission or developmental disorders was
directed to a judicial exception notwithstanding steps requiring contacting
bodily fluid with labeled muscle-specific tyrosine kinase (“MuSK”) and
immunoprecipitating an antibody/MuSK complex from the bodily fluid);
Genetic Technologies Ltd. v. Merial LLC, 818 F.3d 1369, 1372 (Fed. Cir.
2016) (finding that method for detection of at least one coding region allele
was directed to a judicial exception notwithstanding steps requiring
amplifying genomic DNA); Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788
F.3d 1371 (Fed. Cir. 2015) (finding that method for preforming a prenatal
diagnosis on a maternal blood sample was directed to a judicial exception
notwithstanding steps requiring obtaining a blood sample and amplifying
paternally inherited nucleic acid from the sample).
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Appellants argue that the claims are analogous to Example 29 of the
May 2016 Interim Guidance on Patent Subject Matter Eligibility (“Interim
Guidelines”). App. Br. 12–13. Claims 1 and 2 of Example 29 are
reproduced below:
1. A method of detecting JUL-1 in a patient, said method
comprising:
a. obtaining a plasma sample from a human patient;
and
b. detecting whether JUL-1 is present in the plasma
sample by contacting the plasma sample with an anti-JUL-1
antibody and detecting binding between JUL-1 and the
antibody.

2. A method of diagnosing julitis in a patient, said method
comprising:
a. obtaining a plasma sample from a human patient;
b. detecting whether JUL-1 is present in the plasma
sample by contacting the plasma sample with an anti-JUL-1
antibody and detecting binding between JUL-1 and the
antibody; and
c. diagnosing the patient with julitis when the
presence of JUL-1 in the plasma sample is detected.
Interim Guidelines at 10. Appellants argue that, under the Interim
Guidelines, claim 1 was patent eligible because it does not “recite or
describe any recognized [judicial] exception” while claim 2 was “ineligible
because it recited the natural law in the Example, namely, ‘a correlation or
relationship between the presence of JUL-1 in a patient’s plasma and the
presence of julitis in the patient.’” App. Br. 13. Appellants argue that claim
67, like claim 1 of Example 29, is patent eligible because it does not recite a
judicial exception. Id. Appellants explain that “the recited steps in claim 67
of selecting a defined patient population, obtaining samples at a defined
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frequency and assaying for the level of markers are not themselves a natural
principle.” Id. at 14. We are not persuaded.
Although we agree with Appellants that the steps of obtaining samples
and assaying for the level of biological markers are not directed to a judicial
exception, claim 67 also requires “detecting the dynamics of immune system
cycling in the patient.” As discussed above, this step requires more than just
assaying samples, it also requires that the samples be analyzed to determine
the length of the patient’s immune system cycle. Claim 67 is thus
distinguishable from claim 1 of Example 29 because it does recite patent
ineligible subject matter.
B. Claim 67 is not Integrated into a Practical Application
Having determined that claim 67 recites a judicial exception, the
Guidance directs us to next consider whether the claims integrate the judicial
exception into a practical application. Summarizing the relevant case law,
the Guidance notes that courts have generally not considered an “additional
element [that] adds insignificant extra-solution activity,” like “mere data
gathering,” to integrate a judicial exception into a practical application. See
Memorandum 55 (citing Mayo as teaching that the “additional element of
measuring metabolites of a drug administered to a patient was insignificant
extra-solution activity, which was insufficient to confer patent eligibility”).
Appellants argue that claim 67 is directed to “a specific application,
namely detecting the dynamics of the immune cycle in a patient having an
autoimmune disease, in which a particular patient population is selected . . .
a defined sampling protocol is followed . . . and the samples are assayed.”
App. Br. 18. We are not persuaded that these limitations integrate the
judicial exception into a practical application.
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Here, in addition to the recited judicial exception, the claim includes
limitations identifying the patient from whom samples are to be taken,
specifying a minimum frequency with which samples are taken, and
requiring that those samples be assayed for the level of CRP. These steps
merely generate data that is analyzed in the step corresponding to the
judicial exception. They represent insignificant extra-solution activity that is
not sufficient to confer patentability on the recited judicial exception. See,
Athena, 915 F.3d at 754 (“[A]pplying standard techniques in a standard way
to observe a natural law does not provide an inventive concept”).7
Appellants argue that selecting a patient who “has only autoimmune
disease and not an infection ensures that the immune system cycling within
the patient is not obfuscated by the infection.” Id. at 18. We are not
persuaded. Although we do not dispute the necessity of obtaining samples
from an uninfected patient in order to accurately analyze immune system
cycling, simply specifying that the samples be obtained from an uninfected
patient does not confer patentability on the claimed method.
Appellants argue that the “element of ‘detecting the dynamics of
immune system cycling by assaying each of the multiple samples for the
level of one or more immune system marker(s)’ was unknown in the art at
the time.” Id. at 19. We are not persuaded because assaying samples is
routine extra solution activity and because the step of “detecting the
dynamics . . .” is, itself, the judicial exception.

7 Our opinion does not address whether taking samples over an extended
time period amounts to insignificant extra solution activity because, as
discussed above, we understand the claims to encompass taking multiple
samples substantially contemporaneously to establish a baseline.
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C. Claim 67 does not Amount to Significantly More than the
Exception
Having determined that the judicial exception – the mental step of
detecting the dynamics of immune system cycling – is not “integrated into a
practical application,” the Guidance directs us to “evaluate the additional
elements individually and in combination . . . to determine whether they
provide an inventive concept (i.e., whether the additional elements amount
to significantly more than the exception itself).” Memorandum 55–56.
Here, we find that the remaining additional elements do not amount to
significantly more than the exception itself because they simply append well
understood, routine, and conventional activities to the recited judicial
exception.
Appellants argue that it was not routine or conventional to obtain
multiple samples. App. Br. 16. Appellants explain that “[o]btaining
multiple samples at a high frequency comes with increased costs in terms of
time, money, inconvenience and more blood draws, and as of the priority
date of the application, it was not routine to obtain multiple samples at the
claimed high frequency.” Id. at 18–19.
We are not persuaded because, as discussed above, the evidence
supports that it was known to establish a baseline CRP level. See, Cohen
¶ 390.8 The evidence also supports that a baseline would involve obtaining
multiple samples. Although it may be the case that obtaining multiple
samples over an extended time period was unconventional, the claims

8 Cohen was not cited by the Examiner. As our affirmance of the
Examiner’s rejection on the basis that the claims are directed to patent
ineligible subject matter relies on art not cited by the Examiner, we
designate it a new ground of rejection. 37 C.F.R. § 41.50(b).
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encompass the conventional technique of obtaining multiple substantially
contemporaneous samples to establish a baseline CRP level.
Appellants argue that “[w]hile measuring levels of CRP at different
time points from different patient populations may have been known in the
art, measuring them at the claimed frequencies in the claimed subpopulation
of patients was not well known or routine in the art.” Reply Br. 6.
Appellants further argue that the Examiner has failed to show that the
combination of “selecting a patient having an autoimmune disease but not
having an infection” and “obtaining multiple samples from the patient” at
the claimed frequency was “widely prevalent or common use in the
autoimmune disease treatment field.” Id. at 6; see also, id. at 4–5 (citing
Berkheimer v. HP Inc., 881 F.3d 1360 (Fed. Cir. 2018)). We are not
persuaded.
For the reasons discussed above, we find that obtaining a CRP
baseline satisfies the limitation requiring obtaining “at least one sample
every three days.” Cohen provides evidence that it was known to measure
CRP levels and to obtain a CRP baseline in patients suffering from an
autoimmune disease. Cohen ¶ 390. Schwenger suggests that CRP serum
levels are “common laboratory parameters.” Schwenger 274. Accordingly,
we are not persuaded that the Examiner’s evidence was insufficient under
Berkheimer.9

9 Our opinion does not address whether obtaining samples over an extended
time period was routine and conventional because, as discussed above, we
understand the claims to encompass taking multiple samples
contemporaneously to establish a baseline.

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Appellants argue that claim 67 does not “tie up” the subject matter of
the judicial exception because the claims recite a “specific sampling protocol
(multiple samples taken from the patient at a frequency of at least one
sample every three days) for a specific population of patients (a patient who
has an autoimmune disease but not an infection).” App. Br. 22. We are not
persuaded because even accepting Appellants’ argument that
monopolization of excepted subject matter is not a concern in this case, “the
absence of complete preemption does not demonstrate patent eligibility.”
Ariosa, 788 F.3d at 1379.
Accordingly, we affirm the Examiner’s rejection of claim 67 as
directed to patent ineligible subject matter. As noted supra, because we rely
on prior art not relied upon by the Examiner to support our reasoning, we
designate this a new ground of rejection. Because they were not argued
separately, claims 68–76, 78, and 79 fall with claim 67.

SUMMARY
In summary, we reverse the Examiner’s rejection of claims 67–76, 78,
and 79 under 35 U.S.C. § 103(a) as obvious over the combination of
Schwenger and Weirich.
We affirm the Examiner’s rejection of claims 67–76, 78, and 79 under
35 U.S.C. § 101 as directed to patent ineligible subject matter, but designate
this rejection as a new ground of rejection under 37 C.F.R. § 41.50(b).
We enter a new ground of rejection under 37 C.F.R. § 41.50(b),
rejecting claim 67 as anticipated by and/or obvious over Cohen. We leave it
to the Examiner to address the remaining claims.
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Section 41.50(b) provides “[a] new ground of rejection pursuant to
this paragraph shall not be considered final for judicial review.” Section
41.50(b) also provides:
When the Board enters such a non-final decision, the
appellant, within two months from the date of the decision,
must exercise one of the following two options with respect to
the new ground of rejection to avoid termination of the appeal
as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new Evidence relating
to the claims so rejected, or both, and have the matter
reconsidered by the examiner, in which event the prosecution
will be remanded to the examiner. The new ground of rejection
is binding upon the examiner unless an amendment or new
Evidence not previously of Record is made which, in the
opinion of the examiner, overcomes the new ground of rejection
designated in the decision. Should the examiner reject the
claims, appellant may again appeal to the Board pursuant to this
subpart.
(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same Record. The
request for rehearing must address any new ground of rejection
and state with particularity the points believed to have been
misapprehended or overlooked in entering the new ground of
rejection and also state all other grounds upon which rehearing
is sought.

Further guidance on responding to a new ground of rejection can be
found in the Manual of Patent Examining Procedure § 1214.01.
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; 37 C.F.R. § 41.50(b)