ORACLE INTERNATIONAL CORPORATION

Patent Trials and Appeals Board

Jun 2, 2020

13706529 - (D) (P.T.A.B. Jun. 2, 2020)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/706,529 12/06/2012 John Andrew KELLEGREW 2011-0090US01 1091
74739 7590 06/02/2020
Potomac Law Group, PLLC (Oracle International)
8229 Boone Boulevard
Suite 430
Vienna, VA 22182
EXAMINER
SEOH, MINNAH L
ART UNIT PAPER NUMBER
3689
NOTIFICATION DATE DELIVERY MODE
06/02/2020 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):
bgoldsmith@potomaclaw.com
eofficeaction@appcoll.com
patents@potomaclaw.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte JOHN ANDREW KELLEGREW and
MARK RAYMOND RINKER
____________

Appeal 2019-006690
Application 13/706,529
Technology Center 3600
____________

Before JOHN A. EVANS, JOHN P. PINKERTON, and
MICHAEL M. BARRY, Administrative Patent Judges.

EVANS, Administrative Patent Judge.

DECISION ON APPEAL
Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner’s
decision to reject claims 1, 4–8, 10, 11, 14–16, and 19–21, which constitute
all pending claims. Appeal Br. 22–31 (Claims App.). Appellant has
canceled claims 2, 3, 9, 12, 13, 17, and 18. Id. at 24, 25, 27, 30 (Claims
App.). We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.2

1 We use “Appellant” to refer to the “applicant” as defined in 37 C.F.R.
§ 1.42. Appellant identifies Oracle International Corporation as the real
party in interest. Appeal Br. 2.
2 Rather than reiterate the arguments of Appellant and the Examiner, we
refer to the Appeal Brief (filed March 25, 2019, “Appeal Br.”), the Reply
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STATEMENT OF THE CASE
The claims relate generally to a system for managing and reporting
adverse events that may occur in a clinical trial. See, e.g., Spec. ¶¶ 1, 5, 21,
26.
Invention
Claims 1, 11, and 16 are independent. Claim 1 is illustrative and is
reproduced below.
1. A non-transitory computer-readable medium
having instructions stored thereon that, when executed by a
processor, cause the processor to electronically transmit data to
a safety compliance management system associated with a
regulatory agency in response to an adverse event of a clinical
trial, the adverse event is an adverse change in health that
occurs in a patient participating in the clinical trial, the
electronically transmitting comprising:
monitoring one or more interactions with an adverse
event component by a user of an electronic data capture system,
wherein the adverse event component represents the adverse
event and the electronic data capture system is configured to
capture data associated with clinical trials;
receiving a first event in response to a first interaction
with the adverse event component by the user, wherein the first
event indicates a change to a data value of a safety data field
and that the adverse event is to be reported to the safety
compliance management system, wherein the first interaction
comprises selecting a first displayable element that marks the
adverse event as one to be reported to the safety compliance

Brief (filed September 10, 2019, “Reply Br.”), the Examiner’s Answer
(mailed July 10, 2019, “Ans.”), the Advisory Action (mailed January 4,
2019, “Advisory”), the Final Office Action (mailed October 25, 2018,
“Final”), and the Specification (filed December 6, 2012, “Spec.”) for their
respective details.
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management system, and wherein the safety data field is
monitored in response to the adverse event;
initiating a timer to a user-defined time interval in
response to a reception in a queue of the first event;
collecting data that is stored within the electronic data
capture system; and
in response to elapsing of the user-defined time interval
of the timer before a second event is received in the queue,
automatically electronically transmitting the collected data to
the safety compliance management system, the electronically
transmitting further comprising use of a user-defined safety data
logical schema that defines a subset of the data within the
electronic data capture system to be monitored after the data is
sent, through an integration component, to the safety
compliance management system, wherein the safety compliance
management system is configured to manage and report safety
data to a regulatory authority and the data includes one or more
data fields that can be mapped to an enterprise business object
that can be transmitted within an enterprise business message;
wherein the second event is in response to a second
interaction with the adverse event component by the user and
indicates that the adverse event is ready to be reported to the
safety compliance management system, and
wherein the second interaction comprises selecting a
second displayable element, different from the first displayable
element, that marks the data associated with the adverse event
as ready for reporting to the safety compliance management
system;
wherein the adverse event is always electronically
transmitted to the safety compliance management system as a
result of either the elapsing of the user-defined time interval of
the timer or the receiving of the second event, wherein the
transmitting as a result of receiving the second event is in near
real time.
Appeal Br. 22–23 (Claims App.).
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References
Name Reference Date
Strong US 6,167,523 Dec. 26, 2000
Trinks et al.
(Trinks) US 6,952,695 B1 Oct. 4, 2005
Klass et al.
(Klass) US 2009/0138289 A1 May 28, 2009
Goldner et al.
(Goldner) US 2009/0313170 A1 Dec. 17, 2009
Connors et al.
(Connors) US 2012/0143617 A1 June 7, 2012
Rejections
The Examiner rejected Claims 1, 4–8, 10, 11, 14–16, and 19–21 under
35 U.S.C. § 101 as directed to a judicial exception (i.e., an abstract idea)
without significantly more. Final 4–21.
The Examiner rejected Claims 1, 7, 8, 10, 11, 16, and 21 under
35 U.S.C. § 103 as being unpatentable over Connors, Klass, and Trinks. Id.
at 21–37.
The Examiner rejected Claims 4, 5, 14, 15, 19, and 20 under
35 U.S.C. § 103 as being unpatentable over Connors, Klass, Trinks, and
Strong. Id. at 38–42.
The Examiner rejected Claim 6 under 35 U.S.C. § 103 as being
unpatentable over Connors, Klass, Trinks, Strong, and Goldner. Id. at 42–
45.

ANALYSIS
In making our decision, we have reviewed the rejections of claims 1,
4–8, 10, 11, 14–16, and 19–21 and considered Appellant’s arguments. We
have considered only those arguments Appellant actually raised in the
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Briefs. Appellant has waived any argument it could have made but chose
not to in the Briefs. See 37 C.F.R. § 41.37(c)(1)(iv). Appellant’s arguments
do not persuade us of Examiner error. Rather, we adopt as our own the
Examiner’s findings, reasoning, and conclusions, as set forth in the Final
Office Action (Final 4–45), Advisory Action (Advisory 1–2), and
Examiner’s Answer (Ans. 4–25). For emphasis, we provide the following
discussion that highlights certain parts of the record before us.
CLAIMS 1, 4–8, 10, 11, 14–16, AND 19–21: INELIGIBLE SUBJECT MATTER.
Appellant argues these claims as a group. Appeal Br. 4–11; Reply Br.
2–3. Therefore, we decide the appeal of the § 101 rejection of claims 1, 4–8,
10, 11, 14–16, and 19–21 with reference to illustrative claim 13 and refer to
the rejected claims collectively herein as “the claims.” See 37 C.F.R.
§ 41.37(c)(1)(iv); In re Marco Guldenaar Holding B.V., 911 F.3d 1157,
1162 (Fed. Cir. 2018).
We have reviewed the record de novo. SiRF Tech., Inc. v. Int’l Trade
Comm’n, 601 F.3d 1319, 1331 (Fed. Cir. 2010) (“Whether a claim is drawn
to patent-eligible subject matter is an issue of law that we review de novo.”).
Based on our review of the record in light of recent policy guidance on
patent subject matter eligibility under 35 U.S.C. § 101,4 we sustain the § 101
rejection of claims 1, 4–8, 10, 11, 14–16, and 19–21, as discussed in greater

3 Our § 101 analysis for claim 1 applies equally to claims 4–8, 10, 11, 14–
16, and 19–21, which are not argued separately with particularity.
4 USPTO, 2019 Revised Patent Subject Matter Eligibility Guidance, 84(4)
Fed. Reg. 50–57 (Jan. 7, 2019) (“Revised Guidance” or “Rev. Guid.”); see
also USPTO, October 2019 Patent Eligibility Guidance Update (Oct. 17,
2019), https://www.uspto.gov/sites/default/files/documents/
peg_oct_2019_update.pdf.
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detail below.
35 U.S.C. § 101
Section 101 provides that a patent may be obtained for “any new and
useful process, machine, manufacture, or composition of matter, or any new
and useful improvement thereof.” 35 U.S.C. § 101. The Supreme Court has
long recognized, however, that § 101 implicitly excludes “[l]aws of nature,
natural phenomena, and abstract ideas” from the realm of patent-eligible
subject matter, as monopolization of these “basic tools of scientific and
technological work” would stifle the very innovation that the patent system
aims to promote. Alice Corp. v. CLS Bank Int’l, 573 U.S. 208, 216 (2014)
(quoting Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S.
576, 589 (2013)); see also Mayo Collaborative Servs. v. Prometheus Labs.,
Inc., 566 U.S. 66, 72–78 (2012); Diamond v. Diehr, 450 U.S. 175, 185
(1981).
Under the mandatory Revised Guidance, we reconsider whether
Appellant’s claims recite:
1. any judicial exceptions, including certain groupings of abstract ideas
(i.e., mathematical concepts, certain methods of organizing human
interactions 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 reach the
issue of whether the claim:
3. adds a specific limitation beyond the judicial exception that is not
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“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.

A. Whether the claims recite a judicial exception.
The Revised Guidance extracts and synthesizes key concepts
identified by the courts as abstract ideas to explain that the abstract-idea
exception includes the following groupings of subject matter, when recited
as such in a claim limitation(s) (that is, when recited on their own or per se):
(a) mathematical concepts,5 i.e., mathematical relationships, mathematical
formulas, equations,6 and mathematical calculations7; (b) certain methods of
organizing human activity—fundamental economic principles or practices
(including hedging, insurance, mitigating risk); commercial or legal
interactions (including agreements in the form of contracts; legal
obligations; advertising, marketing or sales activities or behaviors; business
relations); managing personal behavior or relationships or interactions

5 Bilski v. Kappos, 561 U.S. 593, 611 (2010) (“The concept of hedging . . .
reduced to a mathematical formula . . . is an unpatentable abstract idea.”).
6 Diehr, 450 U.S. at 191 (“A mathematical formula as such is not accorded
the protection of our patent laws”); Parker v. Flook, 437 U.S. 584, 594
(1978) (“[T]he discovery of [a mathematical formula] cannot support a
patent unless there is some other inventive concept in its application.”).
7 SAP Am., Inc. v. InvestPic, LLC, 898 F.3d 1161, 1163 (Fed. Cir. 2018)
(holding that claims to a “series of mathematical calculations based on
selected information” are directed to abstract ideas).
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between people (including social activities, teaching, and following rules or
instructions)8; and (c) mental processes—concepts performed in the human
mind (including observation, evaluation, judgment, opinion).9
The preamble of independent claim 1 recites:
A non-transitory computer-readable medium having
instructions stored thereon that, when executed by a processor,
cause the processor to electronically transmit data to a safety
compliance management system associated with a regulatory
agency in response to an adverse event of a clinical trial, the
adverse event is an adverse change in health that occurs in a
patient participating in the clinical trial, the electronically
transmitting comprising:
The steps recited in the body of the claim are analyzed in Table I against the
categories of abstract ideas as set forth in the Revised Guidance.
Claim 1 Revised Guidance
[a]10 monitoring one or more
interactions . . . by a user . . . to
capture data associated with clinical
trials;
Mental processes, i.e.,
concepts performed in the human
mind or with pen and paper
(including an observation,
evaluation, judgment, opinion).
Rev. Guid., 84 Fed. Reg. at 52.
[b] receiving a first event in
response to a first interaction . . . by
the user, wherein the first event
“receiving”—Insignificant
extra-solution activity, e.g., mere
data-gathering. Id. at 55 n.31.

8 Alice, 573 U.S. at 219–20 (concluding that use of a third party to mediate
settlement risk is a “fundamental economic practice” and thus an abstract
idea); see Rev. Guid., 84 Fed. Reg. at 52 n.13 for a more extensive listing of
“certain methods of organizing human activity” that have been found to be
abstract ideas.
9 Mayo, 566 U.S. at 71 (“‘[M]ental processes[ ] and abstract intellectual
concepts are not patentable, as they are the basic tools of scientific and
technological work.’” (quoting Gottschalk v. Benson, 409 U.S. 63, 67
(1972))).
10 Step designators, e.g., “[a],” are added to facilitate discussion.
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indicates a change to a data value of
a safety data field and that the
adverse event is to be reported . . . ,
wherein the first interaction
comprises selecting a first
displayable element that marks the
adverse event as one to be reported
. . . , and wherein the safety data
field is monitored in response to the
adverse event;
“selecting” and “wherein the
safety data field is monitored”—
Mental processes, i.e., concepts
performed in the human mind or
with pen and paper (including an
observation, evaluation, judgment,
opinion). Id. at 52.
[c] initiating . . . a user-
defined time interval in response to a
reception in a queue of the first
event;
Mental processes, i.e.,
concepts performed in the human
mind or with pen and paper
(including an observation,
evaluation, judgment, opinion). Id.
[d] collecting data that is
stored . . . ; and
Insignificant extra-solution
activity, e.g., mere data-gathering.
Id. at 55 n.31.
[e] in response to elapsing of
the user-defined time interval . . .
before a second event is received in
the queue, . . . transmitting the
collected data . . . , the . . .
transmitting further comprising use
of a user-defined safety data logical
schema that defines a subset of the
data . . . to be monitored after the
data is sent . . . to manage and report
safety data . . . and the data includes
one or more data fields that can be
mapped to an enterprise business
object that can be transmitted within
an enterprise business message;
“transmitting”—
Insignificant extra-solution
activity, e.g., mere data-gathering.
Id.
“use of a . . . schema that
defines a subset of the data . . . to
be monitored . . . to manage and
report . . .data . . . and the data
includes one or more data fields
that can be mapped to an enterprise
business object that can be
transmitted within an enterprise
business message”— Mental
processes, i.e., concepts performed
in the human mind or with pen and
paper (including an observation,
evaluation, judgment, opinion). Id.
at 52.
[f] wherein the second event is
in response to a second interaction
. . . by the user and indicates that the
Insignificant extra-solution
activity, e.g., mere data-gathering.
Id. at 55 n.31.
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adverse event is ready to be reported
. . . , and

[g] wherein the second
interaction comprises selecting a
second displayable element, different
from the first displayable element,
that marks the data associated with
the adverse event as ready for
reporting . . . ;

Mental processes, i.e.,
concepts performed in the human
mind or with pen and paper
(including an observation,
evaluation, judgment, opinion). Id.
at 52.
[h] wherein the adverse event
is always . . . transmitted . . . as a
result of either the elapsing of the
user-defined time interval . . . or the
receiving of the second event.
Insignificant extra-solution
activity, e.g., post-solution activity.
Id. at 55 n.31.
In view of Table I, these steps describe the concept of collecting
information, monitoring and managing the information, and reporting certain
results (adverse events), which can be performed mentally or with pen and
paper. Thus, steps [a]–[h] of claim 1 recite an abstract idea in the mental
processes grouping. See Rev. Guid., 84 Fed. Reg. at 52; see also, e.g., Spec.
¶ 5 (summarizing the functionality of Appellant’s invention in a similar
way). As this concept relates to tracking and organizing information about
patients in a clinical trial, we note that it may also be characterized as an
abstract idea in the certain methods of organizing human activity grouping.
See, e.g., Final 6–11 (characterizing the concept of Appellant’s invention
similarly and determining that claim 1 recites an abstract idea in the certain
methods of organizing human activity grouping). And although claim 1
recites various computing elements for performing steps [a]–[h], these are no
more than generic computing elements for performing generic computing
functions, as will be discussed in greater detail below. See discussion for
Step 2A(ii), infra. “If a claim, under its broadest reasonable interpretation,
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covers performance in the mind but for the recitation of generic computer
components, then it is still in the mental processes category unless the claim
cannot practically be performed in the mind.” Rev. Guid., 84 Fed. Reg. at
52 n.14. “Likewise, performance of a claim limitation using generic
computer components does not necessarily preclude the claim limitation
from being in . . . the certain methods of organizing human activity
grouping, Alice, 573 U.S. at 219–20.” Id.
We acknowledge that the claim’s use of a user-defined time interval, a
user-defined safety data logical schema, and data fields mapped to an
enterprise business object within an enterprise business message add a
degree of particularity to the claims. But the concepts embodied by these
elements merely encompass the underlying abstract idea as discussed above.
See, e.g., Intellectual Ventures I LLC v. Capital One Financial Corporation,
850 F.3d 1332, 1341 (Fed. Cir. 2017). These elements are, at bottom,
broadly defined rules, arrangements, or labels used for organizing,
managing, and selecting data so as to report adverse events accordingly.
These elements, therefore, do not alter our conclusion that the claimed
invention recites an abstract idea. See id.
In view of the foregoing, we determine that claim 1 recites a judicial
exception, per se.
Step 2A(ii): Judicial Exception Integrated into a Practical
Application?
If the claims recite a patent-ineligible concept, as we determine above,
we proceed to Step 2A(ii), where we determine whether the recited judicial
exception is integrated into a practical application of that exception by: (a)
identifying whether there are any additional elements recited in the claim
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beyond the judicial exception(s); and (b) evaluating those additional
elements individually and in combination to determine whether they
integrate the exception into a practical application.
For the following reasons, we determine that Appellant’s claims do
not integrate the judicial exception into a practical application. See also
Final 11–17 (making the same determination for similar reasons); Ans. 9–
16.
MPEP § 2106.05(a) “Improvements to the Functioning of a Computer
or to Any Other Technology or Technical Field.”
“In determining patent eligibility, examiners should consider whether
the claim ‘purport(s) to improve the functioning of the computer itself’” or
“any other technology or technical field.” MPEP § 2106.05(a).
Appellant argues that the claims “are directed to an improvement to
computer technology” because they “are innately tied to computers and
improve the safety data reporting methodology” by, for example,
“provid[ing] a true integration, where safety data can be sent from an
electronic data capture system to a safety compliance management system in
near real-time.” Appeal Br. 6–7 (emphasis omitted). Appellant explains
that “the claims . . . recite limitations that focus on addressing problems
arising when integrating different systems in a clinical trial adverse event
reporting system.” Id. at 7. Appellant further explains that “a reason the
present claims are subject matter eligible is the combination and integration
of known disparate components to provide a technical solution for
implementing the need to always report adverse events.” Reply Br. 2.
In support of its position, Appellant points to the following limitations
of claim 1:
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receiving a first event in response to a first interaction
with the adverse event component by the user, wherein the first
event indicates a change to a data value of a safety data field
and that the adverse event is to be reported to the safety
compliance management system;
initiating a timer to a user-defined time interval in
response to a reception in a queue of the first event;
in response to elapsing of the user-defined time interval
of the timer before a second event is received in the queue,
automatically electronically transmitting the collected data to
the safety compliance management system, the electronically
transmitting further comprising use of a user-defined safety data
logical schema that defines a subset of the data within the
electronic data capture system to be monitored after the data is
sent, through an integration component, to the safety
compliance management system, wherein the safety compliance
management system is configured to manage and report safety
data to a regulatory authority and the data includes one or more
data fields that can be mapped to an enterprise business object
that can be transmitted within an enterprise business message;
and
the adverse event is always electronically transmitted to
the safety compliance management system as a result of either
the elapsing of the user-defined time interval of the timer or the
receiving of the second event, wherein the transmitting as a
result of receiving the second event is in near real time.
Appeal Br. 7–8 (tabbing added for ease of reference).
We are not persuaded by Appellant’s arguments. It is true that
claim 1 recites a plurality of different computing elements, including “[a]
non-transitory computer-readable medium having instructions . . . executed
by a processor,” “an electronic data capture system,” “a safety compliance
management system,” “an adverse event component,” “a timer,” and “an
integration component.” It is also true that the claimed invention requires
certain computing elements to perform certain functions and to interact with
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one or more other computing elements. But Appellant does not identify—
nor do we find—any persuasive evidence in the claims or Specification that
the claims provide a technical solution to a technical problem or that the
recited computer or software elements (and their associated functionalities)
are anything but generic. Appellant points to paragraph 15 of the
Specification, which discloses that “embodiments of the invention can
provide a true integration, where safety data can be sent from an electronic
data capture system to a safety compliance management system in near real-
time.” See Appeal Br. 6–7 (citing Spec. ¶ 15) (emphasis omitted). But the
Specification describes an example of claim 1’s “integration component” as
merely a communication channel from which predefined data is sent or
received. Spec. ¶ 38. In other words, an “integration component” could just
be a network including a communication channel, such as a wired or
wireless link that integrates two computing systems or devices by allowing
for the connection and sharing of data between them. “That a computer
receives and sends the information over a network—with no further
specification—is not even arguably inventive.” buySAFE, Inc. v. Google,
Inc., 765 F.3d 1350, 1355 (Fed. Cir. 2014). Similarly, “[t]he 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” to render the claims non-abstract.
Id. And although certain embodiments describe the computing elements as
corresponding to Oracle Corporation commercial software products,11

11 See, e.g., Spec. ¶¶ 19, 21, 25, 29, 37–39, 46, 47, Figs. 2, 4 (for example,
the “integration component” may correspond to Oracle’s “integration
endpoint” software).
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Appellant does not describe the features of these products or their
functionalities with any specificity, much less require their use to perform
Appellant’s invention. In addition, the mere fact that data is sent “in near
real time” does not change our analysis because “relying on a computer to
perform routine tasks more quickly or more accurately is insufficient to
render a claim patent eligible.” OIP Techs., Inc. v. Amazon.com, Inc., 788
F.3d 1359, 1363 (Fed. Cir. 2015).12
Appellant also argues that, similar to the Board’s finding in Ex Parte
Smith,13 “the Specification provided further context to conclude that the use
of the claimed timing mechanisms and the associated temporary restraints on
execution of trades provided a specific technological improvement over
prior derivatives trading systems,” “the present specification discloses how
the novel integration functionality recited in the claims provide technical
improvements over prior clinical trial systems.” Appeal Br. 8–9. We do not
agree. First, as discussed above, although the Specification discloses that
“embodiments of the invention can provide a true integration” between
systems, the Specification does not describe with specificity how such
integration is achieved beyond the use of generic computer networking

12 See also Bancorp Servs., L.L.C. v. Sun Life Assurance Co. of Can. (U.S.),
687 F.3d 1266, 1278 (Fed. Cir. 2012) (“[T]he fact that the required
calculations could be performed more efficiently via a computer does not
materially alter the patent eligibility of the claimed subject matter.”); Alice,
573 U.S. at 224 (concluding that “the use of a computer to create electronic
records, track multiple transactions, and issue simultaneous instructions”
was not an inventive concept).
13 Ex Parte Eileen C. Smith, Anthony Montesano, Edward T. Tilly, Mark A.
Esposito, Stuart J. Kipnes, & Anthony J. Carone, Appeal No. 2018-000064,
2019 WL 764497 (PTAB 2019).
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elements and functionality. Second, the claimed timing mechanisms here
are not technical in nature and do not provide any technical solution to a
technical problem. Rather, they are part of the underlying abstract idea and
relate to confirming whether an adverse event exists by allotting an
additional period of time to further evaluate or treat the patient’s condition.
Appellant further argues that, similar to the claims identified as
patent-eligible in Ex Parte Lu, 14 “the present claims are directed to an
improvement in integrating an electronic data capture system with a safety
compliance management system so that adverse events are always sent to a
regulatory agency.” Reply Br. 3. We are not persuaded by Appellant’s
argument. The claims in Lu focused specifically on computer software
technology—in particular, on “‘software endpoint applications [integrated]
with a single transaction facility to enable transactions between a first
endpoint and a second endpoint’ and [electronic data interchange (EDI)]
messages which are received and generated relative that first endpoint.” Lu,
at *4. There, the Board explained that “the advance over the prior art is a
mechanism (‘utility’) for ‘forward[ing] an EDI request from a sending party
to applications that may act as either a payer or provider,’” which “solves
the problem of integration between these two parties by providing the
developer with an application that is capable of automatically generating an
Electronic Data Interchange (EDI) response message to a request.” Id. at *5
(citing U.S. Patent Application No. 12/185,178, Spec. ¶ 4).

14 Ex Parte Anh Q. Lu, Gautham Pamu, & David Y. Yu, Appeal No.
2017-007127, 2018 WL 5631453 (PTAB 2018).

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By contrast, the focus of claim 1 as currently recited is not on an
improvement to computer technology, but on an algorithm for collecting,
managing, monitoring, and reporting patient information relating to a
clinical trial. And as discussed above, although the claim recites various
computing elements, these elements are recited generically without the level
of specificity needed to characterize the claim as being directed to an
improvement in computer or software technology. Likewise, the
Specification describes embodiments of these elements and functions in no
more than generic terms. See, e.g., Spec. ¶¶ 14, 16–20, 46, Fig. 1.
MPEP § 2106.05(b) Particular Machine.
The Bilski15 machine-or-transformation test is only applicable to
method (process) claims on appeal in the present application. Although
method claims 11, 14, and 15 are computer-implemented using a plurality of
computing elements, these claims do not recite a particular machine. Rather,
the Specification describes embodiments that use such computing elements
in no more than generic terms as a tool for performing the recited processes.
See, e.g., Spec. ¶¶ 14, 16–20, 46, Fig. 1. “[A]dditional elements that invoke
computers or other machinery merely as a tool to perform an existing
process will generally not amount to significantly more than a judicial
exception.” MPEP 2106.05(b)(II) (citing Versata Development Group v.
SAP America, 793 F.3d 1306, 1335 (Fed. Cir. 2015)).
MPEP § 2106.05(c) Particular Transformation.
This section of the MPEP guides: “Another consideration when
determining whether a claim recites significantly more is whether the claim

15 Bilski v. Kappos, 561 U.S. 593 (2010).

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effects a transformation or reduction of a particular article to a different state
or thing.” “‘[T]ransformation and reduction of an article to a different state
or thing is the clue to the patentability of a process claim that does not
include particular machines.’” Bilski, 561 U.S. at 658 (quoting Benson, 409
U.S. at 70) (emphasis added and internal quotation marks omitted).
Appellant’s claims, which recite monitoring, receiving, selecting,
initiating, collecting, transmitting, managing, reporting, mapping, and
marking operations—do not effect a “transformation or reduction of an
article into a different state or thing constituting patent-eligible subject
matter,” but instead merely create, receive, transmit, store, evaluate,
manipulate or reorganize data. See In re Bilski, 545 F.3d 943, 962 (Fed. Cir.
2008) (en banc), aff’d sub nom. Bilski, 561 U.S. at 593; see also
CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1375 (Fed. Cir.
2011) (“The mere manipulation or reorganization of data . . . does not satisfy
the transformation prong.”). Applying this guidance here, we determine
Appellant’s claims fail to satisfy the transformation prong of the Bilski
machine-or-transformation test.
MPEP § 2106.05(e) Other Meaningful Limitations.
This section of the MPEP guides:
For a claim that is directed to a judicial exception to be
patent-eligible, it must include additional features to ensure that
the claim describes a process or product that applies the
exception in a meaningful way, such that it is more than a
drafting effort designed to monopolize the exception. The
claim should add meaningful limitations beyond generally
linking the use of the judicial exception to a particular
technological environment to transform the judicial exception
into patent-eligible subject matter.
MPEP § 2106.05(e).
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“Diamond v. Diehr provides an example of a claim that recited
meaningful limitations beyond generally linking the use of the judicial
exception to a particular technological environment” by reciting “additional
elements such as the steps of installing rubber in a press, closing the mold,
constantly measuring the temperature in the mold, and automatically
opening the press at the proper time,” which “sufficiently limited the use of
the mathematical equation to the practical application of molding rubber
products.” Id. (citing Diehr, 450 U.S. at 177–78, 184, 187). “In contrast,
the claims in Alice Corp. v. CLS Bank International did not meaningfully
limit the abstract idea of mitigating settlement risk” because “the additional
elements such as the data processing system and communications controllers
. . . merely linked the use of the abstract idea to a particular technological
environment (i.e., ‘implementation via computers’) or were well-understood,
routine, conventional activity.” Id. (citing Alice, 573 U.S. at 226).
We determine that claim 1 does not add “other meaningful
limitations” at least because the additional elements discussed above are
nothing more than generic components performing generic functions, which
do not amount to a meaningful limitation that is significantly more than an
abstract idea.
MPEP § 2106.05(f) Mere Instructions to Apply an Exception.
In view of the foregoing, we find no evidence that the claims do
anything more than invoke generic computer components as a tool in which
computer software instructions apply the judicial exception.
MPEP § 2106.05(g) Insignificant Extra-Solution Activity.
The claims receive, collect, transmit, and send data, which are classic
examples of insignificant extra-solution activity. Rev. Guid., 84 Fed. Reg.
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55, 55 n.31; see also, e.g., Bilski, 545 F.3d at 963.
MPEP § 2106.05(h) Field of Use and Technological Environment.
“[T]he Supreme Court has stated that, even if a claim does not wholly
pre-empt an abstract idea, it still will not be limited meaningfully if it
contains only insignificant or token pre- or post-solution activity—such as
identifying a relevant audience, a category of use, field of use, or
technological environment.” See Alice, 134 S.Ct. at 2356. Here, even
though the limitations of claim 1 may be “narrowly drawn” to certain
instances and arrangements of information about a patient participating in a
clinical trial, limiting an abstract idea to a particular field of use in this
manner does not convert an otherwise ineligible concept into an inventive
one. See Rev. Guid., 84 Fed. Reg. at 55, id. nn. 31–32. Nor does the claim’s
implementation using the recited computing elements do more than
generally link the use of a judicial exception to a particular technological
environment. See id. at 55. Appellant does not present any persuasive
evidence otherwise.
In view of the foregoing, we determine the claims are “directed to” a
judicial exception.
Step 2B: Does the Claim Provide an Inventive Concept?
Because the claim has been determined to be directed to a judicial
exception under revised Step 2A, we now evaluate the additional elements
individually and in combination under Step 2B to determine whether they
provide an inventive concept (i.e., whether the additional elements amount
to significantly more than the exception itself). Rev. Guid., 84 Fed. Reg. at
56. It is indicative of the absence of an inventive concept where the claims
simply append well-understood, routine, conventional activities previously
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known to the industry, specified at a high level of generality, to the judicial
exception. Id.
Here, the Examiner determines that “[w]hen the additional elements in
claim 1 are considered as an ordered combination, they amount to a generic
technological platform on which commercially available software is
executed to carry out well-understood, routine, and conventional functions
pursuant to compliance with regulatory obligations.” Final 15, see also id. at
13–17; see Ans. 9–10 (citing Spec. ¶¶ 16–17 as evidence that the claims do
not recite a particular computer). In particular, the Examiner explains that
“[t]he safety compliance management system, electronic data capture
system, and integration component are apparently built upon the computer
recited as generic components, where the individual labels or titles for each
of these additional elements describes the function rather than structure and
as such does not amount to any particular computer.” Final 13. The
Examiner further explains that these additional elements are recited at a high
level of generality, correspond to commercially available products, and,
therefore, are well-understood, routine, and conventional in the field. Id. at
14; Ans. 17–18. The Examiner additionally explains how the functions
performed by these additional elements are well-understood, routine, and
conventional. Final 14–15; Ans. 17–18.
We agree with the Examiner. Appellant’s disclosure describes the
claimed computer system consistent with its being well-understood, routine,
and conventional, at a high level of generality. See, e.g., Spec. ¶¶ 14, 16–20,
46, Fig. 1. For example, the Specification discloses that:
Processor 22 may be any type of general or specific purpose
processor. . . . Memory 14 can be comprised of any
combination of random access memory ("RAM"), read only
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memory ("ROM"), static storage such as a magnetic or optical
disk, or any other type of machine or computer-readable
medium. System 10 further includes a communication device
20, such as a network interface card or other communications
interface, to provide access to a network. As a result, a user
may interface with system 10 directly, or remotely through a
network or any other method. A computer-readable medium
may be any available medium that can be accessed by processor
22. A computer-readable medium may include both a volatile
and nonvolatile medium, a removable and non-removable
medium, a communication medium, and a storage medium. A
communication medium may include computer readable
instructions, data structures, program modules or other data in a
modulated data signal such as a carrier wave or other transport
mechanism, and may include any other form of information
delivery medium known in the art. A storage medium may
include RAM, flash memory, ROM, erasable programmable
read-only memory ("EPROM"), electrically erasable
programmable read-only memory ("EEPROM"), registers, hard
disk, a removable disk, a compact disk read-only memory
("CD-ROM"), or any other form of storage medium known in
the art. . . . Database 34 can be an operational database, an
analytical database, a data warehouse, a distributed database, an
end-user database, an external database, a navigational
database, an in-memory database, a document-oriented
database, a real-time database, a relational database, an object-
oriented database, or any other database known in the art. . . .
[E]ach functionality may be performed by hardware (e.g.,
through the use of an application specific integrated circuit
("ASIC"), a programmable gate array ("PGA"), a field
programmable gate array ("FPGA"), etc.), or any combination
of hardware and software.
Spec. ¶¶ 16, 17, 20, 46.
And, as the Examiner explains, the Specification’s disclosure that
certain computing elements may correspond to certain Oracle software
products appears to indicate that these products were commercially available
at the time of invention, which likewise appears to indicate that these
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elements were well-understood, routine, and conventional in accordance
with Berkheimer16 and the Berkheimer memo.17 See Ans. 17–18.
We also note that Appellant’s § 101 arguments include assertions that
certain claim elements are novel. See, e.g., Appeal Br. 9; Reply Br. 2–3.
But “‘novelty’ . . . is of no relevance in determining . . . patentable subject
matter.” Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307,
1315 (Fed. Cir. 2016) (emphasis omitted) (quoting Diehr, 450 U.S. at 188–
89).18
In view of the foregoing, we sustain the rejection of claims 1, 4–8, 10,
11, 14–16, and 19–21 under 35 U.S.C. § 101.
CLAIMS 1, 4–8, 10, 11, 14–16, and 19–21: OBVIOUSNESS.
In an obviousness analysis, the cited references must be considered
for the entirety of what they teach and suggest to one skilled in the art. See,
e.g., In re Hedges, 783 F.2d 1038, 1039 (Fed. Cir. 1986) (citing In re
Wesslau, 353 F.2d 238, 241 (CCPA 1965)). Further, each reference cited by
the Examiner must be read, not in isolation, but for what it fairly teaches in
combination with the prior art as a whole. See In re Merck & Co., 800 F.2d
1091, 1097 (Fed. Cir. 1986). The relevant inquiry is “what the combined
teachings of th[os]e references would have suggested to those of ordinary

16 Berkheimer v. HP Inc., 881 F.3d 1360, 1369 (Fed. Cir. 2018).
17 Robert W. Bahr, Changes in Examination Procedure Pertaining to
Subject Matter Eligibility, Recent Subject Matter Eligibility Decision
(Berkheimer v. HP, Inc.), USPTO 3 (2018) (“Berkheimer Memo”).
18 See also Two-Way Media Ltd. v. Comcast Cable Commc’ns, LLC, 874
F.3d 1329, 1340 (Fed. Cir. 2017) (“[e]ligibility and novelty are separate
inquiries”); Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1151
(Fed. Cir. 2016) (“The search for a § 101 inventive concept is . . . distinct
from demonstrating § 102 novelty.”).
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skill in the art.” In re Keller, 642 F.2d 413, 425 (CCPA 1981) (emphasis
added). Here, in rejecting claim 1 as obvious, the Examiner relies on the
combined teachings of Connors, Klass, and Trinks. Final 21–34; see also
Advisory Act. 1–2; Ans. 19–25.
Appellant argues claims 1, 4–8, 10, 11, 14–16, and 19–21 together as
a group. See Appeal Br. 14–20; Reply Br. 3–4. Appellant’s arguments in
the Appeal Brief rest on the following two assertions:
(1) Connors’s mobile communications devices 110 and documentation
server 138 fail to disclose the “electronic data capture system” and
“safety compliance management system”, respectively, along with
certain associated functionalities, as recited in claim 1 (Appeal Br.
14–19; and (2)
(2) Klass merely discloses a waiting period before maybe sending an
alert, whereas the claim requires “always” sending an alert (id. at
19–20) (emphasis omitted).
For the foregoing reasons, Appellant’s arguments do not persuade us of
Examiner error.
In particular, Appellant argues that Connors’s mobile communications
devices 110 fail to disclose “user-defined safety data logical schema that
defines a subset of the data within the electronic data capture system to be
monitored after the data is sent.” Appeal Br. 17–18. Appellant also argues
that Klass does not disclose this limitation because “there is NO
DISCLOSURE of the monitoring the data by the SENDERS of the data in
Klass, as would be required by the claims.” Id. at 19. These arguments do
not persuade us of error.
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As an initial matter, Appellant is incorrect in asserting that claim 1
requires “monitoring the data by the SENDERS of the data.” Id. Rather,
the claim language at issue recites “a subset of the data . . . to be monitored
after the data is sent,” which does not specify the entity performing the
monitoring, nor does it even require that monitoring actually occur.
Therefore, applying the broadest reasonable interpretation of the claim
language, the Examiner finds, and we agree, that Klass teaches the disputed
limitation with its disclosure of an adverse drug events (ADE) monitoring
system that uses predefined ADE rules to see if the data corresponds to a
patient’s lab and pharmacy data received over a network from laboratory and
pharmacy information systems. Final 29 (citing Klass ¶¶ 42–43, 52–54, 66,
Figs. 3, 6, 7). Because the Examiner has shown that Klass teaches the
disputed limitation, we need not address whether Connors does as well.
Keller, 642 F.2d at 425.
Appellant also argues, without further explanation, that Connors’s
mobile communications devices 110 fail to disclose several other limitations
of claim 1. Appeal Br. 17. These arguments are not persuasive because
Appellant failed to present substantive arguments and supporting evidence
persuasive of Examiner error regarding the aforementioned disputed
limitations. See In re Lovin, 652 F.3d 1349, 1357 (Fed. Cir. 2011) (“[W]e
hold that the Board reasonably interpreted Rule 41.37 to require more
substantive arguments in an appeal brief than a mere recitation of the claim
elements and a naked assertion that the corresponding elements were not
found in the prior art.”). Moreover, Appellant’s argument is not persuasive
because it attacks Connors individually, whereas the Examiner relies on the
combined teachings of Connors, Klass, and Trinks for teaching or
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suggesting the disputed limitations. Keller, 642 F.2d at 425.
Appellant further argues that “Klass fails to disclose any components
that can be considered the recited ‘electronic data capture system’ and
‘safety compliance management system associated with a regulatory
agency.’” Appeal Br. 18. This argument attacks Klass, but the Examiner
relies on Connors for teaching the disputed elements. See Final Act. 23–24;
Keller, 642 F.2d at 425. Moreover, the Examiner finds, and we agree, that
Connors teaches an electronic data capture system and safety compliance
management system with its disclosures of a mobile communications device
and a documentation server (that can report SAE results to the FDA),
respectively. Final 23–24 (citing, e.g., Connors ¶¶ 24, 40, 54–55); see also
Connors ¶ 35.
Claim 1 further recites “wherein the adverse event is always
electronically transmitted to the safety compliance management system as a
result of either the elapsing of the user-defined time interval of the timer or
the receiving of the second event.” Appellant argues Klass does not disclose
this limitation because “in Klass the alert is being sent back to the healthcare
provide[r] FROM WHICH THE DATA WAS RECEIVED,” whereas “the
claims require the adverse event to be sent from where the event was
generated (i.e., the electronic data capture system) to the ‘safety compliance
management system’ upon expiration of the timer.” Appeal Br. 19–20.
But the Examiner relies not only on Klass, but on the combined
teachings of Connors and Klass for rendering the disputed limitation
obvious. Final Act. 30–32; Ans. 22–24. More specifically, the Examiner
finds Connors’s reporting of an SAE to the documentation server
immediately upon receipt from the participant teaches this limitation except
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for the adverse event being sent as a result of “the elapsing of the
user-defined time interval of the timer.” Final Act. 27–28 (citing Connors
¶¶ 54, 60) (emphasis omitted). The Examiner cites Klass merely “as
evidence that it was known in the art to condition the transmission of an alert
regarding an adverse event on the expiration of a timeframe or user-defined
time period.” Ans. 22 (citing Klass ¶¶ 9, 61, 74, 78, 107); see also Final
Act. 30–32. In other words, according to the Examiner, “the origin and
destination of the adverse event alert or report is taught in cited portions of
Connors (Action, pp. 27–28), and Klass is relied upon only to teach that the
transmitting of the alert or report is in response to user-defined time interval
expiring as shown by the italicized portion of the limitation in the office
action (Action, p. 30).” Ans. 24.
We find no error in the Examiner’s findings at least because Klass
discloses generating and sending an alert about a potential ADE (“adverse
event is . . . electronically transmitted”) after a defined waiting period has
ended (“elapsing of the user-defined time interval”) without proper or
appropriate action being taken. See, e.g., Klass ¶¶ 73–74. We also find
reasonable the Examiner’s explanation that combining the cited teachings of
Connors with those of Klass to arrive at the disputed limitation “is merely a
combination of prior art elements according to known techniques to produce
predictable results.” Final Act. 33, see also id. at 32–33. And using Klass’s
waiting period allows for additional evaluation or treatment of the patient to
ensure that a potential ADE does exist (see, e.g., Klass ¶ 73), which may
well yield an improvement in the accuracy and reliability of ADE reporting
in systems such as Connors’s. Appellant’s arguments do not persuasively
rebut the Examiner’s findings and explanations.
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For similar reasons, we are not persuaded by Appellant’s argument
that the Examiner erred because in Klass, an alert may not “always” be sent,
for example, if appropriate action is taken during the waiting period. See
Appeal Br. 19–20. The Examiner relies on Connors, not Klass, for teaching
the concept of “always” electronically transmitting an alert. Final Act. 27–
28 (citing Connors ¶¶ 54, 60). And nevertheless, Klass also teaches this
feature because an alert is generated and sent every time proper or
appropriate action has not been taken with respect to a potential ADE during
the defined waiting period. See Ans. 23.
Appellant’s argument that the ADE in Klass is not the same as the
claimed “adverse event” (Reply Br. 3–4) fares no better. This argument
attacks the teachings of Klass individually, but the Examiner’s rejection is
based on the combined teachings of Connors and Klass, which include the
unrebutted finding that Connors teaches an adverse event with its disclosure
of a serious adverse event related to a clinical trial. See, e.g., Final Act. 22–
23 (citing Connors ¶¶ 11–13, 24). That there may be minor contextual
differences between Klass’s ADE and the claimed “adverse event” is of no
moment. While Appellant may have shown that the references have
differences, this alone is insufficient to rebut a prima facie case of
obviousness. See In re Beattie, 974 F.2d 1309, 1312–13 (Fed. Cir. 1992).
For the foregoing reasons, we sustain the Examiner’s rejection of
claims 1, 4–8, 10, 11, 14–16, and 19–21 under 35 U.SC. § 103.

CONCLUSION
We AFFIRM the rejection of claims 1, 4–8, 10, 11, 14–16, and 19–21
under 35 U.S.C. § 101.
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We AFFIRM the rejection of claims 1, 4–8, 10, 11, 14–16, and 19–21
under 35 U.S.C. § 103.

In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 4–8, 10, 11,
14–16, 19–21
101 Eligibility 1, 4–8, 10, 11,
14–16, 19–21

1, 4–8, 10, 11,
14–16, 19–21
103 Connors, Klass,
Trinks, Strong,
Goldner
1, 4–8, 10, 11,
14–16, 19–21

Overall
Outcome
1, 4–8, 10, 11,
14–16, 19–21

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