Billye Guthrie et al.

Patent Trials and Appeals Board

Jan 3, 2020

14169251 - (D) (P.T.A.B. Jan. 3, 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.
14/169,251 01/31/2014 Billye Guthrie JR. 005618.P11803 6209
45215 7590 01/03/2020
WOMBLE BOND DICKINSON (US) LLP/ABBOTT CARDIOVASCUL
Attn: IP Docketing
P.O. Box 7037
Atlanta, GA 30357-0037
EXAMINER
NG, JONATHAN K
ART UNIT PAPER NUMBER
3686
NOTIFICATION DATE DELIVERY MODE
01/03/2020 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):
FIP_Group@bstz.com
PTO.MAIL@BSTZ.COM
PTO.MAIL@BSTZPTO.COM
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte BILLYE GUTHRIE JR., JOHN W. CREECH,
LESLIE ORNELAS, DANA HAUDEK, and
CHRISTOPHER LEWIS

Appeal 2018-006893
Application 14/169,251
Technology Center 3600
Before MAHSHID D. SAADAT, MATTHEW J. McNEILL, and
JASON M. REPKO, Administrative Patent Judges.

REPKO, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Under 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s
decision to reject claims 1, 2, 4–8, 11, 13, 15, and 17. 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(a). Appellant identifies the real party in interest as Abbott
Cardiovascular Systems, Inc., 3200 Lakeside Drive, Santa Clara, California
95054. Appeal Br. 3.
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CLAIMED SUBJECT MATTER
The invention relates to monitoring data during medical investigations
or procedures. Spec. ¶ 2.
Claims 1, 8, and 17 are independent. Claim 1 is reproduced below.
1. A system for risk-based monitoring of a clinical trial,
comprising:
a plurality of on-site data input terminals including a first
data input terminal at a first clinical research site and a second
data input terminal at a second clinical research site, the onsite
data input terminals including:
respective terminal processors configured to:
receive data from users, wherein the data includes
clinical trial measurement values from the clinical
research sites corresponding to a clinical variable, and
wherein the data includes a first clinical trial measurement
value for the clinical variable from the first clinical
research site and a second clinical trial measurement value
for the clinical variable from the second clinical research
site,
determine whether the data is valid, and
dispatch the data in response to determining the data
is valid; and
an off-site data analysis server networked with the
plurality of on-site data input terminals to receive the data,
wherein the off-site data analysis server is remote from the
plurality of on-site data input terminals, the off-site data analysis
server including:
a memory configured to store a data monitoring guideline
identifying the clinical variable as a non-critical variable for both
the first clinical research site and the second clinical research
site, wherein the non-critical variable does not require on-site
verification at the first clinical research site and the second
clinical research site, and
a processor configured to:
apply a threshold rule having a probability function
to the clinical trial measurement values to determine a
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probability of error of the clinical trial measurement
values,
determine, based on the probability of error of the
first clinical trial measurement value, the first clinical trial
measurement value is a validation failure exceeding a
predetermined number of validation failures for the first
clinical research site,
modify, in response to determining the first clinical
trial measurement value is the validation failure exceeding
the predetermined number of validation failures for the
first clinical research site, the data monitoring guideline to
identify the clinical variable as a critical variable for the
first clinical research site and not the second clinical
research site, wherein the critical variable requires on-site
verification at the first clinical research site for any
treatment of the clinical trial performed at the first clinical
research site, and
dispatch, in response to modifying the data
monitoring guideline to identify the clinical variable as the
critical variable, an investigation request to cause an
investigator to perform the on-site verification of the
critical variable at the first clinical research site for any
treatment of the clinical trial performed at the first clinical
research site.

Appeal Br. 21–22 (Claims App.).2
THE REJECTION
The Examiner rejects claims 1, 2, 4–8, 11, 13, 15, and 17 under
35 U.S.C. § 101 as patent-ineligible subject matter. Final 2–5; Advisory 2–3.

2 Throughout this opinion, we refer to the Final Office Action (“Final”),
mailed August 30, 2017; the Advisory Action (“Advisory”), mailed January
3, 2018; the Appeal Brief (“Appeal Br.”), filed February 28, 2018; the
Examiner’s Answer (“Ans.”), mailed April 20, 2018; and Reply Brief
(“Reply Br.”), filed June 19, 2018.
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OPINION
I. Principles of Law
Under § 101, patent-eligible subject matter is defined as “any new and
useful process, machine, manufacture, or composition of matter, or any new
and useful improvement thereof.” 35 U.S.C. § 101. But courts have long
held that laws of nature, natural phenomena, and abstract ideas are not
patentable. Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S.
66, 70–71 (2012) (citing Diamond v. Diehr, 450 U.S. 175, 185 (1981)).
These ineligible concepts are implicit exceptions to the statutory categories.
Id. at 71.
The Supreme Court articulated a two-step subject-matter eligibility
test in Mayo and Alice Corp. v. CLS Bank International, 573 U.S. 208
(2014). Alice/Mayo step one asks whether a claim is “directed to” a judicial
exception. Alice, 573 U.S. at 217. In Alice/Mayo step two, 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, 566 U.S. at 79,
78). Step two is described as a search for an “inventive concept.” Id.
The USPTO has published revised guidance on patent subject matter
eligibility. 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed.
Reg. 50 (Jan. 7, 2019) (“Guidance”). Step 1 of the USPTO’s eligibility
analysis asks whether the claimed subject matter falls within the four
statutory categories of invention. Id. at 53–54. Under Step 2A, Prong One of
the Guidance, we determine if the claim recites a judicial exception,
including particular groupings of abstract ideas (i.e., mathematical concepts,
certain methods of organizing human activity, or mental processes). Id. at
52–53. If so, we then analyze the claim to determine whether the recited
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judicial exception is integrated into a practical application under Step 2A,
Prong Two of the Guidance. Id. at 53–55; MPEP §§ 2106.05(a)–(c), (e)–(h)
(9th ed. Rev. 08.2017, Jan. 2018).
Only if the claim fails to integrate the exception and, thus, is “directed
to” the judicial exception, do we then look to whether the claim adds a
specific limitation beyond the judicial exception that is not “well-
understood, routine, conventional activity in the field” or whether the claim
simply appends well-understood, routine, conventional activities previously
known to the industry, specified at a high level of generality, to the judicial
exception. Guidance, 84 Fed. Reg. at 56.
II. Overview of the Examiner’s Rejection and Appellant’s Arguments
The Examiner determines that representative3 claim 1 is a machine
under Step 1 of the USPTO’s eligibility analysis. Advisory 2. The Examiner,
however, concludes that claim 1 is directed to an abstract idea. Id. According
to the Examiner, the claims recite a process that analyzes data. Id. The
Examiner then determines that the additional elements do not amount to
significantly more than the abstract idea. Id. at 2–3. The Examiner finds that
the additional elements were well-known, routine, and conventional. Id.; see
also Final 4.
Appellant argues that “the claims are not analogous to any established
abstract idea.” Appeal Br. 15. According to Appellant, “the limitations of
claim 1 do not represent merely ‘collecting . . . analyzing . . . and
displaying.” Id. Rather, in Appellant’s view, the limitations “set up a
sequence of events that address unique problems associated with the

3 Appellant argues all claims together. See 37 C.F.R. § 41.37(c)(1)(iv). In
particular, Appellant states, “Claims 1–2, 4–8, 11, 13, 15 and 17 stand or fall
together. Claim 1 is the representative claim.” Appeal Br. 14.
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changing landscape of clinical trial monitoring.” Id. (citing Spec. ¶ 6).
Appellant argues that “combination of elements of the claims provide an
enhanced monitoring model.” Id. at 16.
III. Step 1: Does the claim fall within a statutory category of invention?
Under Step 1 of the USPTO’s eligibility analysis, we agree with the
Examiner’s determination that the claimed subject matter falls within one of
the four statutory categories of invention because the claim recites a
machine. Guidance, 84 Fed. Reg. at 53–54. Indeed, claim 1 recites a system
comprising terminals and a server. Appellant does not dispute the
Examiner’s determination here. See generally Appeal Br.; Reply Br.
IV. Step 2A, Prong One: Does the claim recite a judicial exception?
A. The Guidance
We next consider whether the claim recites a judicial exception to the
statutory category. Guidance, 84 Fed. Reg. at 51. “[A] claim recites a
judicial exception when the judicial exception is ‘set forth’ or ‘described’ in
the claim.” October 2019 Update: Subject Matter Eligibility 1 (USPTO Oct.
17, 2019), https://www.uspto.gov/sites/default/files/documents/
peg_oct_2019_update.pdf (“October 2019 Update”).
The Guidance synthesizes the key concepts identified by the courts as
abstract ideas into three primary subject-matter groupings: mathematical
concepts, certain methods of organizing human activities, and mental
processes. Guidance, 84 Fed. Reg. at 52.
Under the broadest reasonable interpretation, claim 1 recites an
abstract idea within the Guidance’s mental-process grouping. In the sections
that follow, we explain how the claim sets forth or describes an evaluation or
judgment that can practically be performed in the mind or with the
assistance of pen and paper. See id. at 52 n. 14 (collecting cases).
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B. “determine whether data is valid”
Claim 1 recites that the terminal processors are configured to
“determine whether the data is valid.” Appeal Br. 12. As for that data, claim
1 recites, in part,
the data includes clinical trial measurement values from the
clinical research sites corresponding to a clinical variable, and
wherein the data includes a first clinical trial measurement
value for the clinical variable from the first clinical research site
and a second clinical trial measurement value for the clinical
variable from the second clinical research site.
Id.
This determination is an evaluation that can practically be performed
in the human mind. For instance, the Specification discloses that data
validation may involve determining whether a value is outside a range. See
Spec. ¶ 41. Thus, the recited determination can practically be performed
mentally by comparing a number to a range, for instance. See id.
C. “apply a threshold rule”
Claim 1 recites, in part, “apply a threshold rule having a probability
function to the clinical trial measurement values to determine a probability
of error of the clinical trial measurement values.” Appeal Br. 21.
Applying a threshold rule, as recited, can practically be performed in
the human mind. According to the Specification, “Threshold rules provide
ranges in which a value is considered likely accurate, and ranges in which a
value is considered likely inaccurate.” Spec. ¶ 34. Threshold rules can have
a probability function. Id. ¶ 35. Table 1, below, is an example of a
probability distribution. Id.
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Table 1, above, has two columns: systolic pressure (mmHg) and a
probability of error. Id.
In the table, “the probability is 1.0 for clearly erroneous values, and close to
0.0 for likely accurate values.” Id. Applying a threshold rule having a
probability function, as recited, can practically be performed mentally by
reviewing the values in this table.
D. “validation failure”
Claim 1 recites, in part, “determine, based on the probability of error
of the first clinical trial measurement value, the first clinical trial
measurement value is a validation failure exceeding a predetermined number
of validation failures for the first clinical research site.” Appeal Br. 21.
This step can practically be performed in the human mind, or with the
assistance of pen and paper, because it involves no more than keeping track
of the validation failures. For example, “a given value fails validation
because it lies outside a range.” Spec. ¶ 41. A human can mentally determine
whether a value is outside a range.
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E. “modify . . . the data monitoring guideline”
Claim 1 recites, in part,
modify, in response to determining the first clinical trial
measurement value is the validation failure exceeding the
predetermined number of validation failures for the first
clinical research site, the data monitoring guideline to identify
the clinical variable as a critical variable for the first clinical
research site and not the second clinical research site, wherein
the critical variable requires on-site verification at the first
clinical research site for any treatment of the clinical trial
performed at the first clinical research site.
Appeal Br. 21.
Appellant argues that the modify function is not analogous to
“analyzing data.” Id. at 14. According to Appellant, “analyzing data includes
examining data to understand the data but does not encompass modifying the
data, e.g., to identify a clinical variable, which was previously identified as a
non-critical variable, as a critical variable.” Id. at 14–15; see also
Reply Br. 3–4 (discussing the modify function). We find this argument
unpersuasive.
In CyberSource, for instance, the Federal Circuit determined that
“constructing a map of credit card numbers,” as recited by the claims at
issue in that case, could be performed “by writing down a list of credit card
transactions made from a particular IP address.” CyberSource Corp. v. Retail
Decisions, Inc., 654 F.3d 1366, 1372–73 (Fed. Cir. 2011). Yet the court
concluded that the constructing step was a mental process. Id. Also, the
October 2019 Update instructs Examiners that a claim encompassing a
human mentally performing steps with the aid of a pen and paper recites a
mental process. October 2019 Update 9 (discussing CyberSource, 654 F.3d
at 1372–73).
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Here, the modify function, as recited above, can practically be
performed in the human mind with the assistance of pen and paper.
According to the Specification, the data monitoring guideline (DMG) lists
each data point in the case report form. Spec. ¶ 25. The DMG “describes
which data points are reviewed remotely and which data points must be
reviewed during an on-site monitoring visit” and “includes guidance
regarding data checks and other information needed to assist the CRA during
on-site and remote data review and to help ensure consistency.” Id. Because
the step merely involves modifying this information, it can practically be
performed with the assistance of pen and paper by recording the
modifications, for instance. Thus, this step is part of the recited mental
process.
F. Conclusion to Step 2A, Prong One
Considering all the limitations together, claim 1 recites a method that
falls within the Guidance’s subject-matter grouping of mental processes.
Thus, claim 1 recites an abstract idea.

V. Step 2A, Prong Two: Is the claim “directed to” the recited judicial
exception?
A. The Guidance
Because claim 1 recites an abstract idea, we now proceed to determine
whether the recited judicial exception is integrated into a practical
application. Guidance, 84 Fed. Reg. at 51. When a claim recites a judicial
exception and fails to integrate the exception into a practical application, the
claim is “directed to” the judicial exception. Id.
We use the term “additional elements” for claim features, limitations,
or steps that the claim recites beyond the identified judicial exception. See
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id. at 55 n.24. In claim 1, the additional elements include (1) “on-site data
input terminals,” (2) “off-site data analysis server,” and (3) sending,
receiving, and storing data with these devices. For the reasons discussed
below, we determine that these additional elements—individually and in
combination—do not indicate that the judicial exception is integrated into a
practical application.
B. “receive data from users”
Claim 1 recites, in part, “receive data from users, wherein the data
includes clinical trial measurement values from the clinical research sites
corresponding to a clinical variable, and wherein the data includes a first
clinical trial measurement value for the clinical variable from the first
clinical research site and a second clinical trial measurement value for the
clinical variable from the second clinical research site.” Appeal Br. 21.
The receive function “adds insignificant extra-solution activity to the
judicial exception.” Guidance, 84 Fed. Reg. at 55. Courts have found that
such activity may not integrate the judicial exception into a practical
application. Id. The Guidance explains that insignificant extra-solution
activity includes “mere data gathering such as a step of obtaining
information about credit card transactions so that the information can be
analyzed” to detect fraudulent transactions. Id. at 55 n.31; CyberSource, 654
F.3d at 1372 (analyzing the step of obtaining transaction data and
determining that “such data-gathering steps cannot alone confer
patentability”); see also MPEP § 2106.05(g) (instructing examiners that
“[a]n example of pre-solution activity is a step of gathering data for use in a
claimed process”).
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In the system of claim 1, the receive function merely collects the data
to be processed. Apart from its role in data gathering, this function does not
impose any meaningful limitation on the claimed system, when considering
the claim as a whole. At most, claim 1’s receive function only further limits
the content itself, which is insufficient to impart patent eligibility. See
CyberSource, 654 F.3d at 1370. Thus, the receive function, considered
individually and in combination with the other limitations, does not indicate
that the claim integrates the abstract idea into a practical application.
C. “a memory configured to store a data monitoring guideline”
Claim 1 recites, in part, “a memory configured to store a data
monitoring guideline identifying the clinical variable as a non-critical
variable for both the first clinical research site and the second clinical
research site, wherein the non-critical variable does not require on-site
verification at the first clinical research site and the second clinical research
site.” Appeal Br. 21.
The MPEP instructs examiners that courts have recognized that the
function of “[s]toring and retrieving information in memory” can be
“insignificant extra-solution activity.” MPEP § 2106.05(d)(II)(collecting
cases). Thus, claim 1’s store function also “adds insignificant extra-solution
activity to the judicial exception.” Guidance, 84 Fed. Reg. at 55.
The recited memory is limited by the type of data stored: a data
monitoring guideline. Yet “[t]he mere combination of data sources,
however, does not make the claims patent eligible.” FairWarning IP, LLC v.
Iatric Sys., Inc., 839 F.3d 1089, 1097 (Fed. Cir. 2016). Like the claims here,
the Federal Circuit found that a server used in its ordinary capacity to store
images was not an improvement to computer functionality. In re TLI
Commc’ns LLC Patent Litig., 823 F.3d 607, 612–13 (Fed. Cir. 2016), cited
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in MPEP § 2106.05(f). Thus, the recited memory, considered individually
and in combination with the other limitations, does not indicate that the
claim integrates the abstract idea into a practical application.
D. “dispatch”
Claim 1 recites, in part, “dispatch the data in response to determining
the data is valid.” Appeal Br. 21. Claim 1 further recites,
dispatch, in response to modifying the data monitoring
guideline to identify the clinical variable as the critical variable,
an investigation request to cause an investigator to perform the
on-site verification of the critical variable at the first clinical
research site for any treatment of the clinical trial performed at
the first clinical research site.
Id. at 22.
Appellant argues that the “additional limitations of claim 1 include
dispatching data from an on-site data input terminal responsive to a validity
determination,” which “allows real-time identification of errors, which
facilitates remote review.” Id. at 16 (citing Spec. ¶ 67).
The recited “dispatch” functions, however, encompass sending
information over a network. For example, dispatching may include sending
data via “email or instant message.” Spec. ¶ 29. The Federal Circuit
explained that the “computers in Alice were receiving and sending
information over networks connecting the intermediary to the other
institutions involved, and the Court found the claimed role of the computers
insufficient.” buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355 (Fed. Cir.
2014). Similarly, the recited dispatch functions are insignificant extra
solution activity. Guidance, 84 Fed. Reg. at 55. So these functions do not
indicate that the claim integrates the abstract idea into a practical
application.
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E. The Terminals and Server
Claim 1 recites, in part, “a plurality of on-site data input terminals
including a first data input terminal at a first clinical research site and a
second data input terminal at a second clinical research site, the onsite data
input terminals including: respective terminal processors configured to:”
perform the functions discussed above. Appeal Br. 21. Claim 1 further
recites “an off-site data analysis server networked with the plurality of on-
site data input terminals to receive the data, wherein the off-site data analysis
server is remote from the plurality of on-site data input terminals, the off-site
data analysis server including” a memory and processor. Id. at 21–22.
An additional element may integrate a judicial exception into a
practical application when, for example, the “additional element implements
a judicial exception with, or uses a judicial exception in conjunction with, a
particular machine or manufacture that is integral to the claim.” Guidance,
84 Fed. Reg. at 55.
But claim 1 does not require a particular machine. Here, claim 1 uses
the terminals and servers in their ordinary capacity to send, receive, and
store data. Unlike a particular machine, claim 1 recites general-purpose
processors that merely execute the abstract idea. Ultramercial, Inc. v. Hulu,
LLC, 772 F.3d 709, 716–17 (Fed. Cir. 2014), cited in MPEP § 2106.05(b)(I).
Considering the terminals and server in combination with the other
limitations, they are merely token additions. Claim 1, for example, does not
recite a particular technical improvement to how the recited processors carry
out the operations.
For all these reasons, the claimed method does not use the recited
computing devices in a way that indicates that the judicial exception has
been integrated into a practical application.
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F. The Combination
Appellant argues that “[t]he combination of elements of the claims
provide an enhanced monitoring model, which is a system for risk-based
monitoring of a clinical trial that increases efficiency and decreases costs as
compared to conventional clinical study monitoring.” Appeal Br. 16 (citing
Spec. ¶ 61). According to Appellant, “the enhanced monitoring model is an
integrated approach that utilizes mutually dependent parts of: increased on-
site monitoring intervals; remote review; and targeted source data
verification.” Id. (citing Spec. ¶¶ 62–66); see also Reply Br. 4 (discussing
technological environments and solving problems with clinical-study
monitoring).
Appellant points to the dispatching and the steps that are part of the
abstract idea itself (e.g., determining a probability of error and an excess of
validation failures, and modifying data monitoring guidelines).
Appeal Br. 16–17. In Appellant’s view, “the additional limitations combine
to solve the specific problems associated with conventional clinical study
monitoring, which can require on-site monitoring visits to review all clinical
data variables regardless of criticality.” Id. at 17.
An improvement to technology or a technical field, for example,
indicates that the claim may have integrated the judicial exception into a
practical application. Guidance, 84 Fed. Reg. at 55. But Appellant has not
shown that this is the case here.
Apart from the abstract idea, claim 1 uses general-purpose processors
and generic memory systems to receive, send, and store data. The problem
being solved relates to organizing a clinical study and on-site monitoring.
Appeal Br. 17. That is, instead of improving technology or a technical field,
claim 1 merely uses the terminals and servers as tools to execute the recited
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abstract idea. See Ans. 4 (discussing technological problems). Thus,
Appellant’s arguments concerning the improvement to technology are
unpersuasive. Appeal Br. 15–17; Reply Br. 4.
G. Other Indicia of Integration
Claim 1 does not recite the other indicia of integration listed in the
Guidance. Guidance, 84 Fed. Reg. at 55. For instance, “[t]ransformation and
reduction of an article ‘to a different state or thing’ is the clue to
patentability of a process claim that does not include particular machines.”
Bilski v. Kappos, 561 U.S. 593, 604 (2010) (quoting Gottschalk v. Benson,
409 U.S. 63, 70 (1972)) (emphasis added); see also MPEP § 2106.05(c). Yet
“not all transformations . . . infuse an otherwise ineligible claim with an
‘inventive concept.’” DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d
1245, 1256 (Fed. Cir. 2014). Unlike some eligible transformations, the
claimed system here does not transform a physical object or substance. See,
e.g., Diehr, 450 U.S. at 184 (a process that transforms rubber).
H. Conclusion to Step 2A, Prong Two
For all the reasons above, claim 1 is directed to the identified abstract
idea.
VI. Step 2B: Does the claim provide an inventive concept?
A. The Guidance
To determine whether a claim provides an inventive concept, the
additional elements are considered—individually and in combination—to
determine whether (1) they add a specific limitation beyond the judicial
exception that is not well-understood, routine, and conventional in the field
or (2) they simply append well-understood, routine, and conventional
activities previously known to the industry, specified at a high level of
generality, to the judicial exception. Guidance, 84 Fed. Reg. at 56. Also, we
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reevaluate our conclusions about the additional elements that we presented
in Step 2A, Prong Two. Id.
B. “receive data from users” and “dispatch”
Claim 1 recites, in part,
receive data from users, wherein the data includes clinical trial
measurement values from the clinical research sites
corresponding to a clinical variable, and wherein the data
includes a first clinical trial measurement value for the clinical
variable from the first clinical research site and a second
clinical trial measurement value for the clinical variable from
the second clinical research site.
Appeal Br. 21. Claim 1 recites, in part, “dispatch the data in response to
determining the data is valid.” Id. Claim 1 further recites,
dispatch, in response to modifying the data monitoring
guideline to identify the clinical variable as the critical variable,
an investigation request to cause an investigator to perform the
on-site verification of the critical variable at the first clinical
research site for any treatment of the clinical trial performed at
the first clinical research site.

Id. at 22.
In OIP Technologies, Inc. v. Amazon.com, Inc., the Federal Circuit
determined that, in the claims at issue, “sending a first set of electronic
messages over a network to devices” encompassed well-understood, routine,
and conventional activity. 788 F.3d 1359, 1363 (Fed. Cir. 2015). Also, the
MPEP instructs examiners that courts recognize that receiving or
transmitting data over a network may be well‐understood, routine, and
conventional activity when claimed generically. MPEP § 2106.05(d)(II)(i)
(collecting cases).
Here, the receiving and dispatching functions are claimed generically.
Apart from the limitations to the data type, claim 1 does not recite how the
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data is received or sent. Thus, we agree with the Examiner that claim 1
merely uses a computer to receive data in a well‐understood, routine, and
conventional way. See Advisory 2–3 (determining that the claimed data
collection uses “[g]eneric computer functions that are well-understood,
routine, and conventional activities previously known to the pertinent
industry”); Ans. 5 (finding that the additional elements are “arranged, and
used, in well-known, routine and conventional fashion(s)”).
C. “a memory configured to store a data monitoring guideline”
Claim 1 recites, in part, “a memory configured to store a data
monitoring guideline identifying the clinical variable as a non-critical
variable for both the first clinical research site and the second clinical
research site, wherein the non-critical variable does not require on-site
verification at the first clinical research site and the second clinical research
site.” Appeal Br. 21.
Courts recognize that storing and retrieving information in memory
may be well‐understood, routine, and conventional activity when claimed
generically. Versata Dev. Grp. v. SAP Am., Inc., 793 F.3d 1306, 1334 (Fed.
Cir. 2015); OIP Techs., 788 F.3d at 1363, cited in MPEP
§ 2106.05(d)(II)(iv). Because the claimed memory merely stores the data
monitoring guideline, the recited computer memory is used in a well‐
understood, routine, and conventional way. See Ans. 5 (finding that the
additional elements are “arranged, and used, in well-known, routine and
conventional fashion(s)”).
D. The Terminals and Server
Claim 1 recites, in part, “a plurality of on-site data input terminals
including a first data input terminal at a first clinical research site and a
second data input terminal at a second clinical research site, the onsite data
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input terminals including: respective terminal processors configured to:”
perform the functions discussed above. Appeal Br. 21. Claim 1 further
recites “an off-site data analysis server networked with the plurality of on-
site data input terminals to receive the data, wherein the off-site data analysis
server is remote from the plurality of on-site data input terminals, the off-site
data analysis server including” a memory and a processor. Id. at 21–22.
The recited terminals and server perform operations that can
practically be performed mentally. See supra § IV. The Specification
discloses that the recited processor can be a general-purpose processor. See,
e.g., Spec. ¶¶ 13, 29 (disclosing general-purpose computers to carry out
some of the functions). Using a computer “only for its most basic function,
the performance of repetitive calculations,” may not impose meaningful
limits on the claim’s scope. Bancorp Servs. v. Sun Life Assurance Co. of
Can. (U.S.), 687 F.3d 1266, 1278 (Fed. Cir. 2012). Because the recited
terminals and servers merely execute the abstract idea, the recited terminals
and servers add nothing more than well-understood, routine, and
conventional activity, specified at a high level of generality, to the abstract
mental process. See MPEP § 2106.05(d)(II)(ii) (citing Parker v. Flook, 437
U.S. 584, 594 (1978); Bancorp, 687 F.3d at 1278).
E. The Combination
Appellant argues that claim 1’s additional limitations are like those in
BASCOM Global Internet Services, Inc. v. AT&T Mobility LLC, 827 F.3d
1341 (Fed. Cir. 2016). Appeal Br. 17–18. For instance, Appellant contends
that the on-site and off-site devices require a “distribution of functionality
within a network.” Id. at 18. In Appellant’s view, “[t]he technology-based
solution locates the function of modifying monitoring guidelines at the off-
site server, which allows for customization of critical variables for individual
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sites based on data received from all sites.” Id. We find these arguments
unpersuasive.
Specifically, the claims in BASCOM involved an inventive
distribution of function between a local computer and a server. See 827 F.3d
at 1350–51. The Federal Circuit noted that “[t]he inventive concept
described and claimed in the ’606 patent is the installation of a filtering tool
at a specific location, remote from the end-users, with customizable filtering
features specific to each end user.” Id. at 1350. “Because the filtering tool on
the ISP server contains each user’s customized filtering mechanism, the
filtering tool working in combination with the ISP server can apply a
specific user’s filtering mechanism to the websites requested by that user.”
Id. at 1345.
Unlike the claims in BASCOM, claim 1 does not recite an inventive
distribution of function between the recited terminals and servers, for
example. Rather, the computers here simply execute the abstract idea, and
the memory stores data. For instance, the terminal processors receive the
data, execute part of the mental process (see supra § IV) and then send data.
Likewise, the server has a processor to execute the mental process (see supra
§ IV), and then it too merely sends data. Thus, the computing components,
in combination, carry out the abstract idea and add nothing similar to
BASCOM’s filtering tool working in combination with an ISP server. See
BASCOM, 827 F.3d at 1345. That is, it is insufficient to simply have some
kind of “distribution of functionality within a network.” See Appeal Br. 17–
18. Here, unlike BASCOM, claim 1 is simply an “abstract-idea-based
solution implemented with generic technical components in a conventional
way.” 827 F.3d at 1351.
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Appellant argues that the additional limitations include
unconventional functions, such as determining the recited probability and
modifying the data monitoring guidelines. Reply Br. 4. These steps,
however, are part of the abstract idea itself. See supra § IV. And “a claim
for a new abstract idea is still an abstract idea.” Synopsys, Inc. v. Mentor
Graphics Corp., 839 F.3d 1138, 1151 (Fed. Cir. 2016). So the limitations on
the mental process do not make claim 1 any less abstract. None of the argued
limitations provide an inventive concept in the non-abstract application
realm. See Appeal Br. 15–18; Reply Br. 4.
Considering all the additional elements discussed above, we
reevaluate our conclusions about whether the recited additional elements
integrate the abstract idea into a practical application. Because the additional
elements add nothing more than well-understood, routine, and conventional
activity, those conclusions stand. Considering both our previous conclusions
and the findings about well‐understood, routine, and conventional activity,
we determine that the claimed method does not use the additional elements
in a way that indicates that the claim provides an inventive concept.
F. The Factual Determinations
Appellant argues that the Examiner has not made the requisite factual
determinations in determining that the additional elements were well-
understood, routine, and conventional. Reply Br. 5 (citing Robert W. Bahr,
Deputy Commissioner for Patent Examination Policy, Changes in
Examination Procedure Pertaining to Subject Matter Eligibility, Recent
Subject Matter Eligibility Decision (Berkheimer v. HP, Inc.) (USPTO April
19, 2018)). We disagree. Here, the Examiner supports the factual findings by
citing paragraph 36 of the published application (paragraph 29 of the
Specification) and Figure 1. Advisory 2; Final 4. Indeed, paragraph 29 of the
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Specification discusses generic computing components, such as a “desktop
computer.” Spec. ¶ 29.
G. Conclusion to Step 2B
Thus, claim 1’s limitations—considered individually and in
combination—do not provide an inventive concept.
H. Summary
Appellant has not persuaded us of error in the rejection of
representative claim 1 under 35 U.S.C. § 101. Thus, we sustain the rejection.
We also sustain the rejection of claims 2, 4–8, 11, 13, 15, and 17, which are
not argued separately. See supra n.3.
CONCLUSION
We affirm the Examiner’s decision to reject claims 1, 2, 4–8, 11, 13,
15, and 17.
DECISION SUMMARY

Claims
Rejected
35 U.S.C. § Reference(s) Affirmed Reversed
1, 2, 4–8, 11,
13, 15, 17
101  Eligibility 1, 2, 4–8, 11,
13, 15, 17

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)(1)(iv).

AFFIRMED