Glen De Vries et al.

Patent Trials and Appeals Board

Jul 24, 2019

14066421 - (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.
14/066,421 10/29/2013 Glen de Vries 20622.0020 (IDF-20) 4102
127350 7590 07/24/2019
Steptoe & Johnson LLP
1330 Connecticut Avenue NW
Washington, DC 20036
EXAMINER
ELLIS, MATTHEW J
ART UNIT PAPER NUMBER
2165
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):
hfox@steptoe.com
ipdocketing@steptoe.com
rgreenfeld@steptoe.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte GLEN DE VRIES, MICHELLE MARLBOROUGH,
CHRISTOPHER BOUND, JOSHUA HARTMAN, and JEEVAN PENDLI1
____________

Appeal 2018-000169
Application 14/066,421
Technology Center 2100
____________

Before CAROLYN D. THOMAS, JOSEPH P. LENTIVECH, and
SCOTT RAEVSKY, Administrative Patent Judges.

THOMAS, Administrative Patent Judge.

DECISION ON APPEAL

Appellants seek our review under 35 U.S.C. § 134(a) of the
Examiner’s Final Rejection of claims 1–18, 20, and 21, all the pending
claims in the present application. Claim 19 is canceled (see Claims
Appendix). We have jurisdiction over the appeal under 35 U.S.C. § 6(b).
An Oral Hearing was held on June 25, 2019.
We AFFIRM-IN-PART.
The present invention relates generally to generating a master clinical
database (see Spec., Abstract).

1 Appellants name Medidata Solutions, Inc. as the real party in interest
(App. Br. 3).
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Claims 1, 7, 15, and 18 are illustrative:
1. A method for generating a clinical record in a clinical
trial database for a clinical site, comprising:
executing a matching algorithm to identify clinical data
corresponding to the clinical site, said clinical data being received
from at least a first and a second database;
receiving additional information concerning the clinical
site;
identifying a user associated with the clinical site who
may confirm the clinical data from the first database and the second
database;
requesting the user to confirm the clinical data;
receiving a confirmation from the user; and
adding to the clinical record clinical trial information
about the clinical site and training the matching algorithm based on
the confirmation.

7. A method for generating a master clinical record in a
master clinical database, comprising:
receiving at the master clinical database, utilizing a
processor, data from at least a first database that comprises at least a
record;
executing a matching algorithm to identify the received
data corresponding to data received from a second database that
comprises at least a record;
calculating a match for the corresponding data, wherein
said calculation determines a degree of confidence;
determining whether the degree of confidence is greater
than or equal to a threshold confidence level;
if the degree of confidence is less than the threshold
confidence level, identifying a user who may confirm the
corresponding data;
requesting, at a time point, from the user confirmation of
the corresponding data;
receiving said confirmation from the user at the time
point;
updating the received data from the first and second
databases with said confirmation;
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repeating said steps of calculating, determining, and
requesting, receiving, and correlating said confirmation until the
degree of confidence is greater than or equal to the threshold
confidence level; and
if said degree of confidence is greater than or equal to the
threshold confidence level, updating the master clinical database by
confirming said updated data comprises a master clinical record.

15. A computer-enabled database system comprising clinical
records, each clinical record comprising:
clinical data corresponding to a clinical site, said clinical
data received from:
at least one public database;
at least one private database; and
the clinical site itself; and
clinical trial information about the performance of the
clinical site, wherein, at a time point, a user associated with the
clinical site is identified who may confirm information from the
public and private databases and confirms said information.

18. A computer readable storage medium, comprising
computer executable instructions embodied therein, to be executed by
a computer, for:
executing a matching algorithm to identify clinical data
corresponding to a clinical site, said clinical data being received from
at least one public database and at least one private database;
identifying, based on a retrieved workflow, at least one
user associated with the clinical site, wherein the workflow consists of
users, tasks, and time points, wherein the tasks are executable at said
time points;
receiving additional information from said at least one
user concerning the clinical site;
requesting, at one or more of the time points, said at least
one user to confirm the corresponding clinical data; and
adding to a clinical record clinical trial information about
the performance of the clinical site.

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Appellants appeal the following rejections:
R1. Claims 1–6 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Toto (US 2004/0078216 A1, Apr. 22, 2004), Jensen (US
2011/0099193 A1, Apr. 28, 2011), Caulfield (US 2004/0158562 A1, Aug. 12,
2004), and Melton,
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2995709/pdfamiajnl2238.pdf.
(Final Act. 2–7);
R2. Claims 7–14 and 212 are rejected under 35 U.S.C. § 103(a) as
being unpatentable over Toto, Jensen, Caulfield, and Vicars (US
2005/0165734 A1, July 28, 2005) (Final Act. 7–14, 19);
R3. Claims 15–17 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Toto, Jensen, and Vicars (Final Act. 14–15); and
R4. Claims 18–20 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Toto, Jensen, Melton, and Vicars (Final Act. 16–19).
In the Examiner’s Answer, the Examiner issues the following new
grounds of rejection, which Appellants also appeal:
R5. Claims 15–17 are rejected under 35 U.S.C. § 101 because the
claimed invention is directed to non-statutory subject matter, i.e., software
per se (Ans. 2–3);
R6. Claims 18 and 20 are rejected under 35 U.S.C. 101 because the
claimed invention is directed to non-statutory subject matter, i.e., a signal
per se (Ans. 3); and

2 In the Final Action, although the heading for the rejection of claims 7–21
list all five references cited (see Final Act. 7), the body of the rejection
reflects that less than all of the cited references are actually being relied
upon for the above noted groups of claims (see id. at 7–19; see also App. Br.
8–9 (footnote 1)).
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R7. Claims 1–14 and 21 are rejected under 35 U.S.C. § 101 because
the claimed invention is directed to patent-ineligible subject matter (Ans. 4–
10).
We review the appealed rejections for error based upon the issues
identified by Appellants, and in light of the arguments and evidence
produced thereon. Ex parte Frye, 94 USPQ2d 1072, 1075 (BPAI 2010)
(precedential).

ANALYSIS
Rejection under § 103(a)
Issue 1: Did the Examiner err in concluding that the cited prior art is
analogous?
Appellants contend:
In order [] “to rely on a reference under 35 U.S.C. § 103, it must be
analogous prior art.” . . . Patent Office classification is not indicative
of analogous art. So, even though all the references the Examiner
used are in class 707, only one (Toto) is in the same field of endeavor
– clinical trials – and none “is reasonably pertinent to the problem
faced by the inventor,” which is facilitating future clinical trials.
Thus, Appellant submits that the references cannot be properly
combined.
(App. Br. 16).
We point out that “[w]hether a reference in the prior art is ‘analogous’
is a fact question.” In re Clay, 966 F.2d 656, 658 (Fed. Cir. 1992) (citing
Panduit Corp. v. Dennison Mfg. Co., 810 F.2d 1561, 1568 n.9 (Fed. Cir.
1987)). There are two separate tests for determining whether a prior art
reference is analogous as follows: (1) whether the art is from the same field
of endeavor, regardless of the problem addressed; and (2) if the reference is
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not within the inventors’ endeavor, whether the reference is reasonably
pertinent to the particular problem with which the inventors are involved. In
re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004). “A reference is reasonably
pertinent if, even though it may be in a different field from that of the
inventor’s endeavor, it is one which, because of the matter with which it
deals, logically would have commended itself to an inventor’s attention in
considering his problem.” In re Icon Health and Fitness, Inc., 496 F.3d
1374, 1379–80 (Fed. Cir. 2007) (citations and quotations omitted).
The field of endeavor test “requires the PTO to determine the
appropriate field of endeavor by reference to explanations of the invention’s
subject matter in the patent application, including the embodiments,
function, and structure of the claimed invention.” In re Bigio, 381 F.3d at
1325. Here, the Examiner merely states:
Multiple reasons for combining Toto and Jensen have been
given including the basis that both are in the same class 707 as
well as the sentence of Melton as pointed out in response to
argument 1 (A). It is recognized that MPEP 2141.01 (a) III.
states that while classification of references are some evidence
of “nonanalogy” or analogy” respectively, the court has found
“the similarities and differences in structure and function of the
inventions to carry far greater weight.”
Again this is only used as a basis for evidence of analogy
between the references.
(Ans. 12.) In other words, the Examiner appears to merely rely upon the
alleged common classification of the cited art (e.g., class 707) to illustrate
analogous art, i.e., evidence that each of the cited art is in the same field of
endeavor. However, we agree with Appellants that “this argument does not
remedy the need for the references to be analogous art to that of the claimed
invention” (Reply Br. 8).
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For instance, the Examiner does not expressly state a determination of
Appellants’ field of endeavor, nor does the Examiner cite any evidence in
the Specification supporting a conclusion that Appellants’ field of endeavor
is the same as the cited references. See In re Bigio, 381 F.3d at 1326 (“[T]he
PTO must show adequate support for its findings on the scope of the field of
endeavor in the application’s written description and claims, including the
structure and function of the invention.”). In addition, MPEP § 2141.01
(a)(II) states:
While Patent Office classification of references and the cross-
references in the official search notes of the class definitions are
some evidence of “nonanalogy” or “analogy” respectively, the
court has found “the similarities and differences in structure and
function of the inventions to carry far greater weight.” In re
Ellis, 476 F.2d 1370 (CCPA 1973).

We note that Appellants’ Specification states that the present
invention relates to “[a] method and system for generating a master clinical
database from disparate sources, including public databases, private
databases, and data from users, correlating the received data, determining a
degree of confidence in and requesting and seeking confirmation of any data
matched from the correlated data” (Abstract). In describing the prior art
upon which the invention improves, the Specification discusses that
“[c]linical trials typically involve numerous subjects, many test sites,
extensive planning and coordination, and are very expensive to run” (¶ 1)
and that “with appropriate data coordination, site and investigator
collaboration may be enabled, and through feedback from other PIs or site
personnel, improved protocol design collaboration may be facilitated” (¶ 2).
To the extent that the Examiner’s use of the cited references is based
on a determination that they are within Appellants’ field of endeavor, the
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Examiner has not provided adequate support for that conclusion in part
because the Examiner fails to cite any evidence in the Specification
supporting a conclusion that Appellants’ field of endeavor is the same as the
cited references.
Likewise, the Examiner does not make any findings in support of a
determination that the cited references are analogous art under the second
test. “A reference is reasonably pertinent if . . . it is one which, because of
the matter with which it deals, logically would have commended itself to an
inventor’s attention in considering his problem.” Klein, 647 F.3d at 1348
(quoting In re Clay, 966 F.2d 656, 659 (Fed. Cir. 1992); see also In re
Oetiker, 977 F.2d 1443, 1447 (Fed. Cir. 1992) (“[I]t is necessary to consider
“the reality of the circumstances’ . . . —in other words, common sense—in
deciding which fields a person of ordinary skill would reasonably be
expected to look for a solution to the problem facing the inventor.”). The
Examiner does not identify the problem with which Appellants are involved,
or explain how the cited references are pertinent to that problem. Appellants
define the problem as “facilitating future clinical trial” (see App. Br. 16).
Because the Examiner has not met the burden of establishing that
Toto, Jensen, Caulfield, Melton, and Vicars constitute analogous art to the
claimed invention, we are constrained by the record to reverse the rejection
of claims 1–18, 20, and 21 as obvious in view of these references. Because
we agree with at least one of the arguments advanced by Appellants, we
need not reach the merits of Appellants’ other arguments.
Accordingly, we will not sustain the Examiner’s obviousness rejection
of claims 1–18, 20, and 21.

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Rejections under § 101
Claims 15–17
Software per se
Issue 2: Did the Examiner err in determining that claims 15–17 are
software per se?
The Examiner determines that “Claim 15 recites ‘[a] computer-
enabled database system comprising clinical record,’ which with the
broadest reasonable interpretation can be interpreted as software per se. . . .
[Appellants’ paragraphs 14, 16, 17, 19, 23, 35, and 45] fail to limit the
database system to a hardware system” (Ans. 2). We agree with the
Examiner.
Step 1 of the patent eligibility analysis is to review the claims to
ensure they fall within one of the enumerated categories of invention under
§ 101, i.e., processes, machines, manufactures, and compositions of matter.
Although Appellants contend that “the Examiner provides absolutely
no support from the MPEP or case law that there is a rejection for ‘software
per se’” (Reply Br. 16), and that this “rejection is contrary to Federal Circuit
case law” (id. at 17), we respectfully point out that the Federal Circuit has
concluded that a claim that recites no more than software, logic, or a data
structure (i.e., an abstraction) does not fall within any statutory category. In
re Warmerdam, 33 F.3d 1354, 1361 (Fed. Cir. 1994). An abstract idea
which constitutes “descriptive material” or a data structure per se is non-
statutory. Id. at 1360–61. Significantly, “[a]bstract software code is an idea
without physical embodiment.” Microsoft Corp. v. AT&T Corp., 550 U.S.
437, 449 (2007); see also MPEP § 2106.03 (“Non-limiting examples of
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claims that are not directed to any of the statutory [§ 101] categories include
. . . ‘software per se[.]’”).
Here, we find Appellants’ claimed “computer-enabled database
system comprising clinical records” is software (a data structure, i.e., a
clinical record comprising clinical data and clinical trial information), and is
therefore non-statutory subject matter, particularly because Appellants fail to
direct our attention to any disclosure that illustrates such a system as being
limited to hardware. As such, under the broadest reasonable interpretation,
claims 15–17 can be interpreted as merely claiming a data structure.
Accordingly, we sustain the rejection of claims 15–17 as being
directed to software per se.

Claims 18 and 20
Issue 3: Did the Examiner err in determining that claims 18 and 20
are directed to a signal per se?
The Examiner determines that claim 18 “can be interpreted as [a]
signal per se [given that] [p]aragraph [0047] of the specification fails to limit
computer-readable medium to non-transitory” (Ans. 3). We agree with the
Examiner.
The broadest reasonable interpretation of a claim drawn to a computer
readable medium (also called machine readable medium and other such
variations) typically covers forms of non-transitory tangible media and
transitory propagating signals per se in view of the ordinary and customary
meaning of computer readable media, particularly when the specification is
silent. See MPEP 2111.01. When the broadest reasonable interpretation of a
claim covers a signal per se, the claim must be rejected under 35 U.S.C.
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§ 101 as covering non-statutory subject matter. Stated differently, signals
are not patentable eligible subject matter under § 101. See In re Nuijten, 500
F.3d 1346, 1356–57 (Fed. Cir. 2007) (transitory embodiments are not
directed to statutory subject matter); see also MPEP § 2106(I) (8th ed. Rev.
9 Aug. 2012); Ex parte Mewherter, 107 USPQ2d 1857 (PTAB 2013)
(precedential).
As pointed out by the Examiner, Appellants’ Specification discloses:
For example, the computer-readable medium may be a
computer-readable signal medium or a computer-readable
storage medium. A computer-readable storage medium may be,
for example, an electronic, optical, magnetic, electromagnetic,
infrared, or semiconductor system, apparatus, or device, or any
combination thereof.
Spec. ¶ 47. Similarly,
A computer-readable signal medium may include a propagated
data signal with computer-readable program code embodied
therein, for example, in baseband or as part of a carrier wave.
Such a propagated signal may take any of a variety of forms,
including, but not limited to, electromagnetic, optical, or any
suitable combination thereof.
Id. ¶ 48.
Because the Specification describes only by example that a computer-
readable storage medium may encompass “electronic, optical, magnetic,
electromagnetic, infrared, or semiconductor system, apparatus, or device,”
the Specification does not necessarily exclude transient signals. The
Specification also describes a “computer-readable signal” medium as
including a propagated data signal, separately from examples of computer-
readable storage medium. However, describing two separate but non-
exclusive lists of examples does not exclude any particular embodiment
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from either list, and therefore does not exclude transitory signals as being
within a computer-readable storage medium. See ScriptPro, LLC v.
Innovation Associates, Inc., 833 F.3d 1336, 1341 (Fed. Cir. 2016) (“[A]
specification’s focus on one particular embodiment or purpose cannot limit
the described invention where that specification expressly contemplates
other embodiments or purposes.”).
Thus, we find unavailing Appellants’ contention that “there is no basis
for the Examiner’s rejection [because] Claim 18 does not claim a signal per
se, under the ‘broadest reasonable interpretation’” (Reply Br. 18), given In
re Nuijten and the disclosures in Appellants’ Specification.
Accordingly, we sustain the rejection of claims 15–17 as being
directed to a signal per se.

USPTO Step 1–Categories of Invention in 35 U.S.C. § 101
Claims 15–18 and 20
Not Falling Within One of the Enumerated Categories of Invention
The threshold analysis of whether a claim is directed to one of the
four statutory categories of invention, i.e., a process, machine, manufacture,
or composition of matter, is referred to as “Step 1” in the patent-eligibility
inquiry under 35 U.S.C. § 101. As noted supra, we have concluded that
claims 15–17 are directed to software per se and claims 18 and 20 are
directed to a signal per se, which do not fall into one of the statutory
categories of invention delineated under 35 U.S.C. § 101. As such, claims
15–18 and 20 fail Step 1 of the subject matter eligibility analysis.
Accordingly, we will not proceed to Step 2A for such claims.
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On the other hand, claims 1–14 and 21 recite “methods” which qualify
as “processes” under § 101. As such, we shall proceed to Step 2A to
determine whether claims 1–14 and 21 recite abstract ideas.

Claims 1–14 and 21
Issue 4: Did the Examiner err in determining that the claims are
directed to a judicial exception without significantly more?
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 the 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.”). For example, 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,
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594–95 (1978)); and mental processes (Gottschalk v. Benson, 409 U.S. 63,
69 (1972)).
Recently, the USPTO published revised guidance on the application
of 35 U.S.C. § 101. USPTO’s 2019 Revised Patent Subject Matter
Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019) (“Revised Guidance”).
Under the Revised Guidance “Step 2A,” the office first looks 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)). 84 Fed. Reg. at
51–52, 55.
Only if a claim (1) recites a judicial exception and (2) does not
integrate that exception into a practical application, does the Office then
(pursuant to the Revised Guidance “Step 2B”) 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. 84 Fed. Reg. at 56.
Step 2A, Prong 1 (Does the Claim Recite a Judicial Exception?)
With respect to independent method claims 1 and 7, the Examiner
determines that the claims are directed to the abstract idea of “comparing
information regarding a sample or test subject to a control or target data”
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(Ans. 3 (citing Ambry/Myriad CAFC)), which we conclude are at least
mental processes. For at least the following reasons, we are persuaded that
representative claim 1 recites an abstract idea.
The Specification discloses:
Currently the typical process by which a pharmaceutical company or a
contract research organization (a CRO) selects a site and/or a principal
investigator (PI) for participation in a clinical trial includes finding
data about the site or PI from existing spreadsheets, contacting key
opinion leaders to determine which PIs provide appropriate sites,
confirming PIs who are interested, qualified and available, having
sites and PIs upload documents such as curricula vitae (CVs), and/or
performing qualification feasibility, e.g., a questionnaire sent by
sponsors to confirm sites are adequately equipped to conduct a trial.
. . . The present invention may be used to reduce clinical study start-
up costs by generating and maintaining a cross-sourced database of
sites, site personnel, subjects, and site histories and performance.
Systems utilizing such a database could engage physicians (e.g., PIs)
and sponsors in a collaboration prior to, during, or after the conduct of
a clinical trial, including the review of study protocols to avoid
unnecessary, expensive amendments mid-study and other uses
described herein. Such collaboration has other benefits, because the
participation of better performing sites and investigators (e.g., those
having histories or performing well in previous studies) is likely to
lead to better data and a more efficient and economically conducted
trial. In an industry in which a significant fraction of sites could be
considered “under-performing,” reducing this fraction will result in
significant savings for a given clinical trial.
Spec. ¶ 13.
Representative claim 1 recites at least the following limitations: (1)
“executing a matching algorithm to identify clinical data,” (2) “receiving
additional information,” (3) “identifying a user associated with the clinical
site,” (4) “requesting the user to confirm the clinical data,” (5) “receiving a
confirmation from the user,” (6) “adding to the clinical record clinical trial
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information,” and (7) “training the matching algorithm based on the
confirmation.” Independent claim 7 recites similar limitations including
(8) “receiving data,” (9) “calculating a match,” (10) “determining whether
the degree of confidence is greater than or equal to a threshold,” and
(11) “updating the received data.” These limitations, under their broadest
reasonable interpretation, recite at least mental processes, i.e., concepts
performed in the human mind and/or by using pen and paper.
A claim recites a mental process when the claim encompasses acts
people can perform using their minds or pen and paper. See, e.g.,
CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372–73 (Fed.
Cir. 2011) (determining that a claim whose “steps can be performed in the
human mind, or by a human using a pen and paper” is directed to an
unpatentable mental process); Elec. Power Grp. LLC v. Alstom, 830 F.3d
1350, 1353–54 (Fed. Cir. 2016) (collecting information and “analyzing
information by steps people go through in their minds, or by mathematical
algorithms, without more, [are] essentially mental processes within the
abstract-idea category”); see also, University of Utah Res. Foundation v.
Ambry Genetics Corp., 774 F.3d 755, 763 (Fed. Cir. 2014) (referring to prior
holding that claim 1 was patent ineligible because “it claimed an abstract
mental process of ‘comparing’ and ‘analyzing’ two gene sequences”). This
is true even if the claim recites that a generic computer component performs
the acts. See, e.g., Versata Dev. Grp., Inc. v. SAP Am., Inc., 793 F.3d 1306,
1335 (Fed. Cir. 2015) (“Courts have examined claims that required the use
of a computer and still found that the underlying, patent-ineligible invention
could be performed via pen and paper or in a person's mind.”); see also 2019
Eligibility Guidance 84 Fed. Reg. at 52 n.14 (“If a claim, under its broadest
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reasonable interpretation, 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.”).
The aforementioned limitations, under their broadest reasonable
interpretation, encompass acts people can practically perform using their
minds or pen and paper because people can perform the: “executing,”
“training,” and “calculating” steps by using pen and paper to both evaluate
the algorithm to identify clinical data and a match and also train the
algorithm based on a confirmation received from a user; “receiving,”
“identifying,” and “determining” steps by simply looking at and reading the
additional information and degree of confidence and/or observing a
confirmation and a user name associated with the site; “requesting” step by
merely asking a user verbally or by written note to confirm; and the
“adding” and “updating” steps by using pen and paper to note the trial
information and confirmation.
Although Appellants contend that “claim 1 does not compare
information and detect changes” in contrast to the claims in Ambry (see
Reply Br. 20), we note that the claimed “executing a matching algorithm”
must inherently include a comparison step in order to detect a match.
Because all of the above processes can be performed mentally or
using a pen and paper, we conclude that independent claim 1 recites the
abstract idea of mental processes. See Revised Guidance, Step 2A, Prong 1
(Groupings of Abstract Ideas). Although independent claim 7 recites a
“database” and “processor,” it recites similar features that can be otherwise
performed using a pen and paper. Therefore, claim 7 also recites the abstract
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idea of mental processes. See Revised Guidance, Step 2A, Prong 1
(Groupings of Abstract Ideas). The dependent claims recite similar
processes or functions, and Appellants have not shown that such claims are
directed to other non-abstract functions or processes.
Therefore, for at least the aforementioned reasons, we agree with the
Examiner that the claims recite an abstract idea, which we conclude are
“mental processes.”
Step 2A—Prong 2 (integration into Practical Application) 3
Under the Revised Guidance, we now must determine if additional
elements in the claims integrate the judicial exception into a practical
application (see MPEP § 2106.05(a)–(c), (e)–(h)).
We discern no additional element (or combination of elements)
recited in Appellants’ representative claim 1 that integrates the judicial
exception into a practical application. See Revised Guidance, 84 Fed. Reg.
at 54–55 (“Prong 2”). For example, Appellants’ claimed additional elements
(e.g., “database,” and “processor”) do not: (1) improve the functioning of a
computer or other technology; (2) are not applied with any particular
machine (except for a generic computer); (3) do not effect a transformation
of a particular article to a different state; and (4) are not applied in any
meaningful way beyond generally linking the use of the judicial exception to
a particular technological environment, such that the claim as a whole is

3 We acknowledge that some of the considerations at Step 2A, Prong 2,
properly may be evaluated under Step 2 of Alice (Step 2B of the Office
revised guidance). For purposes of maintaining consistent treatment within
the Office, we evaluate them under Step 1 of Alice (Step 2A of the Office
revised guidance). See Revised Guidance, 84 Fed. Reg. at 55 n.25, 27–32.

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more than a drafting effort designed to monopolize the exception. See
MPEP §§ 2106.05(a)–(c), (e)–(h).
As for Appellants’ contention that the “claimed invention claims a
specific way of generating a clinical trial database record – there is no
monopolization of database generation” (Reply Br. 21), we treat this as a
“preemption” argument and note that although pre-emption “might tend to
impede innovation more than it would tend to promote it, ‘thereby thwarting
the primary object of the patent laws”’ (Alice, 134 S. Ct. at 2354 (citing
Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S.Ct. 1289, 1293
(2012))), “the absence of complete preemption does not demonstrate patent
eligibility” (Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1379
(Fed. Cir. 2015)). Moreover, because we find the claimed subject matter
covers patent-ineligible subject matter, the pre-emption concern is
necessarily addressed.
Appellants further contend that the “claimed invention is directed to
generating a clinical trial database record, similar to the claims in Enfish . . .
[because the operations] are at least as patentable as [Enfish’s] ‘configuring’
of computer memory ‘according to a logical table’ made up of logical rows
and logical columns and ‘indexing [of] data stored in said table’” (Reply Br.
21). We disagree with Appellants.
For example, the claims at issue in Enfish were directed to a specific
type of data structure, i.e., a self-referential table for a computer database,
designed to improve the way a computer carries out its basic functions of
storing and retrieving data. See Enfish, LLC v. Microsoft Corp., 822 F.3d
1327, 1335–36 (Fed. Cir. 2016). In rejecting a § 101 challenge, the court in
Enfish held that “the plain focus of the claims is on an improvement to
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computer functionality itself, not on economic or other tasks for which a
computer is used in its ordinary capacity.” Id. at 1336.
Here, Appellants do not persuasively point to anything in the claim
that resembles the inventive self-referential data structure at issue in Enfish.
Nor have Appellants persuasively shown that Appellants’ claims are similar
to Enfish’s “configuring of memory” or “indexing of data,” as argued.
Appellants also do not direct our attention to anything in the Specification to
indicate that the invention provides an improvement in the computer’s
technical functionality.
Instead, the claimed “clinical record” is “used to reduce clinical study
start-up costs . . . engage physicians (e.g., PIs) and sponsors in a
collaboration . . . lead to better data and a more efficiently and economical
conducted trial” (see Spec. ¶ 13). That is, here the arguably innovative
technique of the appealed claims is based on economics or other tasks for
which a computer is used in its ordinary capacity.
Moreover, nothing in the claims, understood in light of the
Specification, requires anything other than an off-the-shelf, conventional
computer used for collecting and processing/analyzing various
information/data. Therefore, unlike Enfish, the claims are directed not to
improvement in computer capabilities, but to the results of applying an
abstract idea. Thus we agree with the Examiner that “[t]here is no indication
that the combination of elements improves the functioning of a computer or
improves any other technology” (Ans. 5).
Similarly, Appellants contend that that claims “at least (d) execute a
matching algorithm, (e) calculate a match, and (f) train the algorithm based
on the confirmation. Such specific limitations work together to create a
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more comprehensive database of clinical trial sites and investigators to make
clinical trials more efficient” (Suppl. App. Br. 10 (citing Spec. ¶ 13)).
However, we highlight that simply using a computer to gain efficiency over
a manual process is not sufficient to distinguish a claim from a patent-
ineligible abstract idea. See OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d
1359, 1363 (Fed. Cir. 2015) (“[R]elying on a computer to perform routine
tasks more quickly or more accurately is insufficient to render a claim patent
eligible.”).
Appellants have not provided persuasive evidence or technical
reasoning that the method of claim 1 produces an advance in efficiency or
technological improvement to the clinical trial database.
Appellants also broadly contend that the claimed invention “generates
a concrete outcome, a database that greatly improves the operation of
clinical trials, which is a practical application . . . [that] recites ‘a specific
improvement over prior art systems” (Suppl. App. Br. 10). Such an
argument appears to address the “useful, concrete, and tangible result” test.4
However, the standard for reviewing claims for statutory subject matter is
ever evolving and this argument in Appellants’ Supplemental Brief, filed
after our Revised Guidance, fails to sufficiently establish that the claims as a
whole integrate the judicial exception into a practical application, for at least
the reasons noted supra.
For at least the reason noted supra, we determine that claim 1

4 See State Street Bank & Trust Co., v. Signature Fin. Group, Inc., 149 F.3d
1368, 1371 (Fed. Cir. 1998).
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(1) recites a judicial exception and (2) does not integrate that exception into
a practical application. Thus, representative claim 1 is directed to the
aforementioned abstract idea.

Alice/Mayo—Step 2 (Inventive Concept)
Step 2B identified in the Revised Guidance
Turning to the second step of the Alice inquiry, we now look to
whether claim 1 contains any “inventive concept” or adds anything
“significantly more” to transform the abstract concept into a patent-eligible
application. Alice, 573 U.S. at 216. As recognized by the Revised
Guidance, an “inventive concept” under Alice step 2 can be evaluated based
on whether an additional element or combination of elements:
(1) “adds a specific limitation or combination of limitations
that are not well-understood, routine, conventional
activity in the field, which is indicative that an inventive
concept may be present;” or
(2) “simply appends well-understood, routine, conventional
activities previously known to the industry, specified at a
high level of generality, to the judicial exception, which
is indicative that an inventive concept may not be
present.”

See Revised Guidance, 84 Fed. Reg. at 56; see MPEP § 2106.05(d).
The Examiner determines that:
The claims include terms such as “processor,” but generic
computer components such as these are recited as performing
generic computer functions that are well-understood, routine
and conventional.
Ans. 4.
Additionally, this claim contains the limitation of clarifying the
databases as public and private. . . . databases being public and
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private is well understood, routine, and conventional. . . . The
claims include terms such as “processor,” but generic computer
components such as these are recited as performing generic
computer functions that are well-understood, routine and
conventional.
Id. at 6.
Additionally, this claim contains the limitation of retrieving a
workflow with tasks and timepoints. . . . adding a workflow for
when and how the function is done still matches the abstract
idea and is also well understood, routine, and conventional. . . .
Additionally, this claim contains the limitation of adjusting a
threshold. . . . adding a threshold still matches the abstract idea
and is also well understood, routine, and conventional.
Id. at 7.
Additionally, this claim contains the limitation of maintaining
confidentiality requirements. . . . keeping confidentiality still
matches the abstract idea and is also well understood, routine,
and conventional.
Id. at 8.
As an initial matter, we note that regarding independent claims 1 and
7, Appellants point out the Examiner’s determination that the claimed
“processor” is generic and well-understood, routine, and conventional (see
Suppl. App. Br. 3–4), but fail to specifically rebut such a determination. If
Appellants fail to present arguments on a particular issue, the Board will not,
as a general matter, unilaterally review those uncontested aspects of the
rejection. Ex Parte Frye, 94 USPQ2d at 1075 (citing, inter alia, Hyatt v.
Dudas, 551 F.3d 1307, 1313–14 (Fed. Cir. 2008) (the Board may treat
arguments appellant failed to make for a given ground of rejection as
waived)). As a result, Appellants fail to identify any issue regarding
whether the claimed “processor” in independent claim 7 is well-understood,
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routine, or conventional. Furthermore, as recognized by the Supreme Court,
“the mere recitation of a generic computer cannot transform a patent-
ineligible abstract idea into a patent-eligible invention.” See Alice, 134 S.
Ct. at 2359 (concluding claims “simply instruct[ing] the practitioner to
implement the abstract idea of intermediated settlement on a generic
computer” not patent eligible).
As such, we find no element or combination of elements recited in
Appellants’ independent claims 1 and 7 that contains any “inventive
concept” or adds anything “significantly more” to transform the abstract
concept into a patent-eligible application, in part because, Appellants have
not adequately explained how independent claims 1 and 7 are performed
such that it is not a routine and conventional function of a generic processor.
This is equally applicable to dependent claims 2, 4–6 and 21, which are not
argued separately.
Accordingly, because Appellants’ independent claims 1 and 7 (and
dependent claims 2, 4–6, and 21) are directed to a patent-ineligible abstract
concept, does not include additional elements that integrate the judicial
exception into a practical application, and does not add a specific limitation
beyond the judicial exception that is not “well-understood, routine, and
conventional,” we sustain the Examiner’s rejection of the claims 1, 2, 4–7,
and 21 under 35 U.S.C. § 101 as being directed to non-statutory subject
matter in light of Alice, its’ progeny, and the Revised Guidance.

Dependent claims 3 and 8–14
On the other hand, Appellants’ contentions focus on the dependent
claims and contend that in specific dependent claims “the types of databases
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used and how a threshold confidence level is determined, confirmation of
data by retrieving a workflow comprising users, tasks, and time points, and
maintaining confidentiality of database records [] are not – and have not
been found to be – well-understood, routine, or conventional” (Suppl. App.
Br. 4). Appellants further contend that “[t]he Examiner did not provide any
evidence to support his conclusion that the [dependent] claims or any
additional elements as ‘well-understood, routine, and conventional’ . . .
contrary to the Berkheimer Guidelines” (id.).
Here, although we agree with the Examiner that the dependent claims
recites a judicial exception, i.e., a mental process (and do not integrate that
exception into a practical application), Appellants raise a persuasive issue
regarding whether the Examiner provided any evidence to support the
conclusion that certain additional elements are well-understood, routine, and
conventional (see MPEP § 2106.05(d)).
Specifically, Appellants highlight claim 3’s “public and private
databases,” claim 8’s “retrieving of a workflow,” claim 9’s “threshold
confidence level,” and claim 13’s “confidentiality requirements” (see claims
3, 8, 9, and 13).
Although the Examiner points out the generic component, i.e.,
processor (see Ans. 4), the Examiner fails to specifically address the above-
noted additional limitations highlighted by Appellants, beyond the
Examiner’s conclusory statement that such features are well-understood,
routine, and conventional (see Ans. 4–8). Appellants specifically rebut the
“well-understood, routine, and conventional” nature of such features.
As such, a factual determination is required. See Berkheimer v. HP
Inc., 881 F.3d 1360, 1369 (Fed. Cir. 2018) (“Whether something is well-
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understood, routine, and conventional to a skilled artisan at the time of the
patent is a factual determination.”). On the record before us, the Examiner
has not provided any factual finding that the specifically claimed features
noted supra are well-understood, routine, or conventional. Thus, under
Alice Step 2B and Revised Guidance (3), the Examiner has not properly
consider the elements of specific dependent claims, both individually and
“as an ordered combination,” to determine whether the additional elements
transform the Examiner’s asserted abstract idea into a patent-eligible
application.
For at least the above reasons, we are constrained by the record to
determine that the Examiner’s rejection of dependent claims 3 and 8–14
under 35 U.S.C. § 101 (Alice and the Revised Guidance) is reversed.

DECISION
We reverse the Examiner’s § 103 rejections R1–R4 of claims 1–18,
20, and 21.
We affirm the Examiner’s § 101 rejection R5 of claims 15–17 as
being directed to software per se.
We affirm the Examiner’s § 101 rejection R6 of claims 18 and 20 as
being directed to a signal per se.
We affirm the Examiner’s § 101 rejection R7 of claims 1, 2, 4–7, and
21 as being directed to patent-ineligible subject matter under Alice, its’
progeny, and the Revised Guidance.
We reverse the Examiner’s § 101 rejection R7 of claims 3 and 8–14 as
being directed to patent-ineligible subject matter under Alice, its’ progeny,
and the Revised Guidance, in light of Berkheimer.
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No period for taking any subsequent action in connection with this
appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED-IN-PART