HOFFMAN, MARK A. et al.

Patent Trials and Appeals Board

Oct 1, 2019

13490012 - (D) (P.T.A.B. Oct. 1, 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.
13/490,012 06/06/2012 MARK A. HOFFMAN CRNI.167735 3565
46169 7590 10/01/2019
SHOOK, HARDY & BACON L.L.P.
(Cerner Corporation)
Intellectual Property Department
2555 GRAND BOULEVARD
KANSAS CITY, MO 64108-2613
EXAMINER
PAULSON, SHEETAL R.
ART UNIT PAPER NUMBER
3626
NOTIFICATION DATE DELIVERY MODE
10/01/2019 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):
BPARKERSON@SHB.COM
IPRCDKT@SHB.COM
docketing.shb@clarivate.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________
Ex parte MARK A. HOFFMAN,
KEVIN MATTHEW POWER, ANDREW MECKLER,
MAHCAMEH MOUSSAVI, and BONNIE LINN BATES
____________________

Appeal 2018-007651
Application 13/490,012
Technology Center 3600
____________________

Before JOHN A. JEFFERY, JUSTIN BUSCH, and
JENNIFER L. McKEOWN, Administrative Patent Judges.

BUSCH, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 10–12, 14–16, and 18–20, which
constitute all the claims pending in this application. We have jurisdiction
over the pending claims under 35 U.S.C. § 6(b).
We AFFIRM.

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies the real party in interest as Cerner
Innovation, Inc. Br. 3.
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CLAIMED SUBJECT MATTER
Appellant’s disclosure relates to “providing indications of clinical-
trial criteria modifications” and, more specifically, providing suggested
clinical-trial criteria modifications based on comparing aggregated patient
data to the criteria that may increase the number of patients eligible for a
trial. Spec. ¶ 6, Abstract. According to the Specification, the invention
addresses the problem that clinical trials often lack sufficient enrollment
because not enough patients are eligible to participate and the clinical-trial
providers “often lack visibility to the impact of specific eligibility criteria on
recruitment rates.” Spec. ¶ 4. Claims 10 and 15 are independent claims, and
claim 10 is reproduced below:
10. A computerized method for providing indications of
clinical-trial criteria modifications, the method comprising:
providing an indication to view one or more suggested
clinical-trial criteria modifications that, if implemented, are
expected to increase a number of patients eligible for a clinical
trial;
receiving a distribution of patient data relative to a
clinical-trial criterion, wherein the distribution represents patient
data that is grouped in a plurality of value ranges indicating a
scope of the clinical-trial criterion;
receiving, via computing device, a suggested criterion
modification, wherein the suggested criterion modification
includes an instruction to modify at least one of the plurality of
value ranges and a new value with which to modify the at least
one of the plurality of value ranges, wherein the new value
modifies the scope of the clinical-trial criterion by increasing the
number of patients eligible for the clinical trial, and wherein the
new value of the suggested criterion modification is identified by
analysis of the distribution of patient data relative to the clinical-
trial criterion;
receiving one or more details pertaining to an expected
result if the new value of the suggested criterion modification is
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used to modify the at least one value range of the clinical-trial
criterion; and
concurrently displaying an indication of the distribution of
patient data relative to the plurality of value ranges, an indication
of the suggested criterion modification for the clinical-trial
criterion, and an indication of the one or more details pertaining
to the expected result that would occur if the suggested criterion
modification is applied.
REJECTIONS
Claims 10–12, 14–16, and 18–20 stand rejected under 35 U.S.C. § 101
as being directed to an abstract idea. Final Act. 2–6.
Claims 15, 16, and 18–20 stand rejected under 35 U.S.C. § 101 as
being directed to non-statutory subject matter. Final Act. 3.
Claims 10–12, 14–16, and 18–20 stand rejected under 35 U.S.C. § 102
as anticipated by Harrison (US 2010/0088245 A1; Apr. 8, 2010). Final
Act. 6–9.
ANALYSIS
We have reviewed the Examiner’s rejections in light of Appellant’s
arguments that the Examiner erred. In reaching this decision, we have
considered all evidence presented and all arguments Appellant made.
Arguments Appellant could have made, but chose not to make in the Brief,
are deemed waived. See 37 C.F.R. § 41.37(c)(1)(iv).
THE 35 U.S.C. § 101 NON-STATUTORY SUBJECT MATTER REJECTION
In addition to concluding claims 15, 16, and 18–20 are directed to an
abstract idea (discussed further below), the Examiner determines these
claims are directed to non-statutory subject matter because they encompass
transitory computer readable storage media. Final Act. 3. Appellant does not
respond to this aspect of the Examiner’s rejection. Therefore, we summarily
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sustain the Examiner’s rejection of claims 15, 16, and 18–20 under 35
U.S.C. § 101 as being directed to non-statutory subject matter.
THE 35 U.S.C. § 101 ABSTRACT IDEA REJECTION
The Examiner concludes claims 10–12, 14–16, and 18–20 are directed
to judicially excepted subject matter. Final Act. 2–6. Appellant argues the
§ 101 rejection of all claims as a group. See Br. 11 (arguing independent
claim 15 and dependent claims 11, 12, 14, 16, and 18–20 are directed to
eligible matter for the same reasons argued with respect to independent
claim 10), 17 (arguing independent claim 15 and dependent claims 11, 12,
14, 16, and 18–20 recite an inventive concept for the same reasons argued
with respect to independent claim 10). We select claim 10 as representative
of the claims with respect to the rejection of claims 10–12, 14–16, and
18–20 as ineligible subject matter for being directed to no more than an
abstract idea. See 37 C.F.R. § 41.37(c)(1)(iv) (2016).
The Supreme Court’s two-step framework guides our analysis of
patent eligibility under 35 U.S.C. § 101. Alice Corp. v. CLS Bank Int’l, 573
U.S. 208, 217 (2014). In addition, the United States Patent and Trademark
Office recently published revised guidance for evaluating subject matter
eligibility under 35 U.S.C. § 101, specifically with respect to applying the
Alice framework. USPTO, 2019 Revised Patent Subject Matter Eligibility
Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019) (“Guidance”).
If a claim falls within one of the statutory categories of patent
eligibility (i.e., a process, machine, manufacture, or composition of matter),
we determine whether the claim is directed to one of the judicially
recognized exceptions (i.e., a law of nature, a natural phenomenon, or an
abstract idea). Alice, 573 U.S. at 217. As part of our inquiry, we “look at the
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‘focus of the claimed advance over the prior art’ to determine if the claim’s
‘character as a whole’ is directed to excluded subject matter.” Affinity Labs
of Tex., LLC v. DIRECTV, LLC, 838 F.3d 1253, 1257 (Fed. Cir. 2016). The
Guidance directs us to address this inquiry using the following two prongs of
analysis: (i) does the claim recite a judicial exception (e.g., an abstract idea),
and (ii) if so, is the judicial exception integrated into a practical application?
84 Fed. Reg. at 54.
Under the Guidance, if the judicial exception is integrated into a
practical application, the claim is patent eligible under § 101. 84 Fed. Reg. at
54–55. If the claim is directed to a judicial exception (i.e., the claim both
recites a judicial exception and fails to integrate the exception into a
practical application), we next determine whether the claim provides an
inventive concept, which includes determining whether any element, or
combination of elements, amounts to significantly more than the judicial
exception. Alice, 573 U.S. at 217; 84 Fed. Reg. at 56.
Here, we conclude representative claim 10 is directed to mental
processes (i.e., a concept performed in the human mind, such as an
observation, evaluation, judgment, and opinion), which are abstract ideas.
See 84 Fed. Reg. at 52. Claim 10 generally is directed to suggesting
modifications to clinical-trial criteria that will increase the number of
patients eligible to participate in the trial.
This is consistent with how Appellant describes the claimed
embodiments of the invention. Br. 8 (“The character of the claim, speaking
generally, focuses on a computerized method that intelligently generates
new criterion-specific values and further generates instructions to implement
the new criterion-specific values in order to redefine a value range for a
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particular criterion used to determine clinical trial eligibility.”); Spec. ¶¶ 6
(“Embodiments of the present invention relate to providing indications of
clinical-trial criteria modifications.”), 22 (“Utilizing the methods and
systems described herein, clinical-trial criteria associated with a particular
clinical trial can be compared to corresponding patient data,” “a suggested
criteria modification can be determined or identified,” and the “suggested
criteria modification can be provided to the clinical-trial provider to assist in
assessing the success of the clinical trial.”), 24 (“[A]n embodiment is
directed to a computerized method for providing indications of clinical-trial
criteria modifications. The method includes providing an indication to view
one or more suggested clinical-trial criteria modifications that, if
implemented, are expected to increase a number of patients eligible for a
clinical trial.”), 25 (describing an embodiment that is directed to computer
instructions for performing the method described in paragraph 24 of the
Specification). Although not dispositive regarding the scope of the claim, we
also note claim 10 explicitly recites it is a “computerized method for
providing indications of clinical-trial criteria modifications.” Br. 26 (Claim
10 preamble); accord Br. 3 (“embodiments of the invention are generally
directed to intelligently formulating new values that, if implemented by a
user setting participation in/eligibility [sic] parameters for each specific
clinical-trial criterion, will modify the scope of in/eligibility [sic] under one
or more of the clinical-trial criteria to boost patient recruitment rates”).
Claim 10 is reproduced below, with the claim limitations that recite
elements of the abstract idea of suggesting modifications to clinical-trial
criteria that will increase the number of patients eligible to participate in the
trial emphasized in italics:
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10. A computerized method for providing indications of
clinical-trial criteria modifications, the method comprising:
providing an indication to view one or more suggested
clinical-trial criteria modifications that, if implemented, are
expected to increase a number of patients eligible for a clinical
trial;
receiving a distribution of patient data relative to a
clinical-trial criterion, wherein the distribution represents
patient data that is grouped in a plurality of value ranges
indicating a scope of the clinical-trial criterion;
receiving, via computing device, a suggested criterion
modification, wherein the suggested criterion modification
includes an instruction to modify at least one of the plurality of
value ranges and a new value with which to modify the at least
one of the plurality of value ranges, wherein the new value
modifies the scope of the clinical-trial criterion by increasing the
number of patients eligible for the clinical trial, and wherein the
new value of the suggested criterion modification is identified by
analysis of the distribution of patient data relative to the clinical-
trial criterion;
receiving one or more details pertaining to an expected
result if the new value of the suggested criterion modification is
used to modify the at least one value range of the clinical-trial
criterion; and
concurrently displaying an indication of the distribution
of patient data relative to the plurality of value ranges, an
indication of the suggested criterion modification for the
clinical-trial criterion, and an indication of the one or more
details pertaining to the expected result that would occur if the
suggested criterion modification is applied.
More particularly, the abstract idea of suggesting modifications to
clinical-trial criteria that will increase the number of patients eligible to
participate in the trial comprises (i) providing an indication to begin the
process of suggesting criteria modifications to increase the number of
patients eligible for a clinical trial; (ii) receiving patient data grouped into
ranges relative to a clinical-trial criterion; (v) receiving a suggested criterion
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modification (including an instruction to modify a value range and a new
value for the value range) that (1) is identified by analyzing the received data
and (2) will increase the number of eligible patients; (vi) receiving details
regarding expected results if the modification is made; and (vii) displaying
the patient data, an indication of the suggested modification, and an
indication of the details regarding expected results. These steps that make up
the concept recited in claim 10 are simply a series of observations,
evaluations, and judgements for suggesting modifications to clinical-trial
criteria that will increase the number of patients eligible to participate in the
trial, and these steps all fall within the types of mental processes considered
abstract—i.e., observations, evaluations, judgments, and opinions. See 84
Fed. Reg. at 52.
Consistent with our Guidance and case law, we conclude this concept
is a mental process and, therefore, an abstract idea. See 84 Fed. Reg. at 52;
Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1067 (Fed.
Cir. 2011) (determining claims that recite reviewing information to
determine a lower-risk immunization schedule were directed to an abstract
idea because they involve only mental processes); Digitech Image Techs.,
LLC v. Elecs. For Imaging, Inc., 758 F.3d 1344, 1351 (Fed. Cir. 2014)
(concluding “taking existing information . . . and organizing this information
into a new form” is an abstract idea); SmartGene, Inc. v. Advanced
Biological Labs., SA, 555 F. App’x 950, 954–56 (Fed. Cir. 2014)
(concluding claims that analyzed provided patient information using
knowledge bases to generate a ranked list of treatment regimens and
advisory information for treatment regimens were directed to an abstract
idea); SAP Am., Inc. v. InvestPic, LLC, 898 F.3d 1161, 1167 (Fed. Cir. 2018)
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(concluding claims were directed to the abstract idea of “selecting certain
information, analyzing it using mathematical techniques, and reporting or
displaying the results of the analysis”). If a claim, under its broadest
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. Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1318
(Fed. Cir. 2016) (“[W]ith the exception of generic computer-implemented
steps, there is nothing in the claims themselves that foreclose them from
being performed by a human, mentally or with pen and paper.”); see Elec.
Power Grp., LLC v. Alstom S.A., 830 F.3d 1350, 1353–54 (Fed. Cir. 2016)
(concluding that “analyzing information by steps people go through in their
minds, or by mathematical algorithms, without more, as essentially mental
processes within the abstract-idea category” and concluding claims directed
to “collecting information, analyzing it, and displaying certain results of the
collection and analysis” were abstract);.
Because claim 10 recites a judicial exception, we next determine
whether it integrates the judicial exception into a practical application.
84 Fed. Reg. at 54. To determine whether the judicial exception is integrated
into a practical application, we identify whether there are “any additional
elements recited in the claim beyond the judicial exception(s)” and evaluate
those elements to determine whether they integrate the judicial exception
into a practical application. 84 Fed. Reg. at 54–55 (emphasis added); see
also Manual of Patent Examining Procedure (“MPEP”) §§ 2106.05(a)–(c),
(e)–(h) (9th ed. Rev. 08.2017, Jan. 2018).
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Here, the additional limitations recited beyond the judicial exception
itself fail to integrate the exception into a practical application. More
particularly, claim 10 does not recite: (i) an improvement to the functionality
of a computer or other technology or technical field (see MPEP
§ 2106.05(a)); (ii) a “particular machine” to apply or use the judicial
exception (see MPEP § 2106.05(b)); (iii) a particular transformation of an
article to a different thing or state (see MPEP § 2106.05(c)); or (iv) any other
meaningful limitation (see MPEP § 2106.05(e)). See also 84 Fed. Reg. at 55.
Rather, the additional elements simply use computers as tools to
implement the abstract idea requiring no more than generic computer
elements to perform generic computer functions or add insignificant extra-
solution activity. The only additional element recited in claim 10 is the
“computing device” via which the suggested modification is received. The
computing device is a generic computer element recited at a high level of
generality. The Specification and claims provide only generic high-level
descriptions of the computing device, without providing detail indicating
these elements include any improvement to existing computers or
technology. Cf. Berkheimer Memo2 § III.A.1; see Spec. ¶¶ 28 (explaining
“[t]he present invention may be operational with numerous other general

2 “Changes in Examination Procedure Pertaining to Subject Matter
Eligibility, Recent Subject Matter Eligibility Decision (Berkheimer v. HP,
Inc.)” at 3 (Apr. 19, 2018), available at
https://www.uspto.gov/sites/default/files/documents/memo-berkheimer-
20180419.PDF (explaining that a specification that describes additional
elements “in a manner that indicates that the additional elements are
sufficiently well-known that the specification does not need to describe the
particulars of such additional elements to satisfy 35 U.S.C. § 112(a)” can
show that the elements are well-understood, routine, and conventional).
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purpose or special purpose computing system environments or
configurations” and listing various generic types of computing systems or
devices, such as “personal computers, server computers, hand-held or laptop
devices”), 30–31 (describing generic computing elements within a “control
server” implemented on “a general purpose computing device”).
Although the recited steps of “providing an indication to view one or
more suggest clinical-trial criteria modifications” and “concurrently
displaying” indications of the patient data, suggested modification, and
expected result details are part of the recited abstract idea, for purposes of
this Decision, we alternatively evaluate these steps as additional elements.
These steps, however, are the type of insignificant extra-solution activity the
courts have determined insufficient to transform judicially excepted subject
matter into a patent-eligible application. See 84 Fed. Reg. at 55, 55 n.31;
MPEP § 2106.05(g); Parker v. Flook, 437 U.S. 584, 590 (1978)
(determining that adjusting an alarm limit is insignificant extra-solution
activity and explaining “[t]he notion that post-solution activity, no matter
how conventional or obvious in itself, can transform an unpatentable
principle into a patentable process exalts form over substance”); Bancorp
Servs., L.L.C. v. Sun Life Assur. Co. of Can., 771 F. Supp. 2d 1054, 1065
(E.D. Mo. 2011) aff’d, 687 F.3d 1266 (Fed. Cir. 2012) (explaining that
“providing data . . . [is] insignificant post-solution activity”); Bilski v.
Kappos, 561 U.S. 593, 612 (2010) (holding the use of well-known
techniques to establish inputs to the abstract idea as extra-solution activity
that fails to make the underlying concept patent eligible); Elec. Power, 830
F.3d at 1354 (recognizing “that merely presenting the results of abstract
processes of collecting and analyzing information, without more (such as
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identifying a particular tool for presentation), is abstract as an ancillary part
of such collection and analysis”).
Appellant asserts representative claim 10 is not directed to an abstract
idea because the claimed method “intelligently generates new criterion-
specific values and further generates instructions to implement the new
criterion-specific values in order to redefine a value range for a particular
criterion used to determine eligibility.” Br. 7–10. Appellant also contends
claim 10 is not directed to an abstract idea because improves on the prior art
by reciting “concrete elements that” solve two problems with existing
solutions—a lack of “information transparency or visibility” because users
or clinicians were unable to see which criterion and value ranges were
negatively affecting patient eligibility and the need to use guessing or trial-
and-error techniques to determine which criteria and values to modify.
Br. 8–9.
Appellant paraphrases claim 10’s limitations and asserts that
“[a]ccordingly, claim 10 provides much more than . . . simply collecting and
comparing known information (Classen) and collecting information,
analyzing it, and displaying certain results of the collection and analysis
(Electric Power Group).” Br. 9–10. Appellant concludes by asserting that
“the character of independent claim 10, viewed as a whole in light of the
Specification, addresses the lack of electronic information transparency and
the piecemeal ‘guess-timation’ that was required in the prior systems and
methods” and, therefore, “claim 10 is not directed to an abstract idea.”
Br. 10.
Notably, Appellant neither claims nor describes any claimed
technological improvement tied to the invention recited in claim 10. Rather,
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Appellant merely claims a general use of a computing device to aid in
analyzing data to determine a suggested modification to achieve a goal of
enlarging a pool of patients eligible to participate in a clinical trial. As
broadly recited, claim 10 encompasses (1) receiving a distribution of patient
data relative to the criterion, an indication to view a suggested modification,
and details regarding a result expected if the modification is made; (2)
providing any suggestion to modify any clinical-trial criterion as long as the
suggestion (i) is derived by analyzing the patient data, (ii) includes both an
instruction to modify the criterion and a new value with which to modify the
range, and (iii) increases the number of patients eligible to participate in the
trial; and (3) displaying any indications of the patient data, suggested
modification, and the expected result details.
Appellant (1) reproduces or paraphrases the various claim limitations,
which recite receiving and/or providing various types of information (i.e.,
patient data, suggested criterion modifications that include an instruction and
a value range, and presenting portions of the information), (2) argues the
claims solve the two-fold problem of prior systems and methods, and
(3) states that the claim language is different from, and more than, what was
recited in Electric Power and Classen. Br. 8–11. However, Appellant does
not persuasively explain why or how the claims differ from claims the
Federal Circuit previously found ineligible. We agree with the Examiner that
the identified “two-fold problem” is a business problem, not a technical
problem, and Appellant’s claimed solution, which captures, analyzes, and
displays information to provide suggested modifications to clinical-trial
criteria, provides a business solution without improving a computer,
technology, or other technical field. See Ans. 3. Analyzing data to provide
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suggested modifications to increase the number of patients eligible for a trial
broadly claims a solution rooted in data collection and analysis, not a
solution rooted in technology.
Moreover, Appellant does not identify particular limitations in claim
10, let alone limitations in addition to the abstract idea, that allegedly
differentiate the claims over those found ineligible in Electric Power and
Classen. Instead, Appellant vaguely alleges claim 10 recites “concrete
elements” and an ordered combination that solve the identified business
problems associated with increasing a desired number of patients to
participate in a clinical trial. These arguments are insufficient to demonstrate
Appellant’s claims are directed to something other than mental processes to
perform the abstract idea of suggesting modifications to clinical-trial criteria
that will increase the number of patients eligible to participate in the trial.
For these reasons, we determine claim 10 recites an abstract idea
comprised of mental steps and fails to integrate the judicial exception into a
practical application. Therefore, claim 10 is directed to an abstract idea, and
we analyze the claims under step two of Alice to determine whether there are
additional limitations that individually, or as an ordered combination, ensure
the claims amount to “significantly more” than the abstract idea. Alice, 573
U.S. at 217–18 (citing Mayo Collaborative Servs. v. Prometheus Labs., Inc.,
566 U.S. 66, 72–73, 77–79 (2012)).
As stated in the Guidance, many of the considerations to determine
whether the claims amount to “significantly more” under step two of the
Alice framework are already considered as part of determining whether the
judicial exception has been integrated into a practical application. 84 Fed.
Reg. at 56. Thus, at this point of our analysis, we determine if claim 10 adds
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a specific limitation, or combination of limitations, that is not well-
understood, routine, conventional activity in the field, or simply appends
well-understood, routine, conventional activities at a high level of generality.
84 Fed. Reg. at 56.
Appellant argues claim 10 recites elements that, considered as an
ordered combination, provide an inventive concept because claim 10 solves
the two problems in prior art systems and methods (i.e., lack of information
transparency and requiring trial-and-error modifications). Br. 13–15.
Appellant argues there is no evidence in the record that claim 10’s elements
were well-understood, routine, and conventional and the fact that claim 10’s
ordered combination of elements is not present “in prior computerized
clinical trial referral systems” demonstrates the ordered combination was not
well-understood, routine, and conventional. Br. 13, 15. Appellant further
asserts claim 10’s ordered combination “confines the claim to a particular
useful application, via a computerized clinical trial referral engine.” Br. 13.
An inventive concept “cannot be furnished by the unpatentable law of
nature (or natural phenomenon or abstract idea) itself.” Genetic Techs. Ltd.
v. Merial L.L.C., 818 F.3d 1369, 1376 (Fed. Cir. 2016); see also 84 Fed.
Reg. at 56; Alice, 573 U.S. at 217 (explaining that, after determining a claim
is directed to a judicial exception, “we then ask, ‘[w]hat else is there in the
claims before us?’” (emphasis added, brackets in original) (quoting Mayo,
566 U.S. at 78)). Instead, an “inventive concept” is furnished by an element
or combination of elements that is recited in the claim in addition to the
judicial exception and sufficient to ensure the claim as a whole amounts to
significantly more than the judicial exception itself. Alice, 573 U.S. at 218–
19 (citing Mayo, 566 U.S. at 72–73); see BSG Tech LLC v. BuySeasons, Inc.,
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899 F.3d 1281, 1290 (Fed. Cir. 2018) (explaining that the Supreme Court in
Alice “only assessed whether the claim limitations other than the invention’s
use of the ineligible concept to which it was directed were well-understood,
routine and conventional,” (emphasis added)).
Appellant does not identify which elements are elements in addition
to the abstract idea, let alone which additional elements or combination of
elements allegedly are not well-understood, routine, and conventional.
Rather, Appellant generally asserts “the elements of independent claim 10,
when considered as an ordered combination, are not well-understood,
routine, or conventional.” Br. 15. As already noted, the majority of claim 10
recites mental processes that are part of the abstract idea.
Claim 10 fails to recite specific additional limitations (or a
combination of limitations) that are not well-understood, routine, and
conventional. Rather, the only additional elements (i.e., the “computing
device” and the two steps we previously noted we alternatively consider an
additional element for purposes of this Decision—“providing an indication
to view one or more suggest clinical-trial criteria modifications” and
“concurrently displaying” indications of the patient data, suggested
modification, and expected result details) are generic computer components
recited at a high level of generality or extra-solution activity, which do not
recite limitations beyond what was well-understood, routine, and
conventional in the field. See Berkheimer Memo § III.A.1; Spec. ¶¶ 28,
30–31.
To the extent Appellant argues claim 10 is similar to the claims held
eligible in BASCOM Glob. Internet Servs., Inc. v. AT&T Mobility LLC, 827
F.3d 1341 (Fed. Cir. 2016), we disagree. See Appeal Br. 12–14.
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In BASCOM, the court found “the patent describes how its particular
arrangement of elements is a technical improvement” and, when construed
in favor of BASCOM,3 the claims may be read to improve an existing
technological process. BASCOM, 827 F.3d at 1350. As discussed above,
claim 10 does not improve an existing technological process, but rather
receives and analyzes data using a generic “computing device” to meet a
desired functional goal (increasing the number of patients eligible for a
trial). Additionally, unlike the arrangement of elements (i.e., installation of a
filtering tool at a specific location) in BASCOM, 827 F.3d at 1349–50, claim
10 does not recite a non-conventional and non-routine arrangement of
known elements because the only component recited in the method is the
“computing device,” which is only used in claim 10 for “receiving, via the
computing device, a suggested criterion modification.” Using a computing
device to receive data, one of the most basic functions of any computing
device, does not even arguably constitute an unconventional or non-routine
arrangement or use of the generic “computing device.”
Finally, Appellant asserts, without further explanation, that claim 10
does not preempt “using different steps or system arrangements” to generate
similar outcomes. Br. 16. We disagree that the lack of complete pre-emption
demonstrates patent eligibility in this case. Claim 10 limits the performance
of the recited mental processes only by providing an indication to view a
suggested modification, using a “computing device” for “receiving . . . a
suggested criterion,” and displaying patient data, the suggested modification,
and the expected results of the modification. Such limitations either

3 In BASCOM, BASCOM appealed the district court’s granting of a motion
to dismiss under Fed. R. Civ. P. 12(b)(6). BASCOM, 827 F.3d at 1341
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constitute details that limit the data used in mental processes or, for the
reasons discussed above, are well-understood, routine and conventional
elements insufficient to integrate the abstract idea into a practical
application.
Moreover, although “preemption may signal patent ineligible subject
matter, the absence of complete preemption does not demonstrate patent
eligibility. . . . Where a patent’s claims are deemed only to disclose patent
ineligible subject matter under the Mayo framework, as they are in this case,
preemption concerns are fully addressed and made moot.” Ariosa
Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1379 (Fed. Cir. 2015);
see also OIP Techs. v. Amazon.com, Inc., 788 F.3d 1359, 1362–63 (Fed. Cir.
2015) (“And [the fact] that the claims do not preempt all price optimization
or may be limited to price optimization in the e-commerce setting do[es] not
make them any less abstract.”).
For the above reasons, Appellant has not persuaded us of Examiner
error, and we sustain the Examiner’s rejection of claims 10–12, 14–16, and
18–20 under 35 U.S.C. § 101 as being directed to ineligible subject matter.
THE 35 U.S.C. § 102 REJECTION
The Examiner finds Harrison discloses every limitation recited in
claims 10–12, 14–16, and 18–20. Final Act. 6–9. Of particular relevance to
the dispositive issue with respect to this Appeal, the Examiner finds
Harrison discloses “receiving . . . a suggested criterion modification”
including “a new value with which to modify the at least one of the plurality
of value ranges,” as recited in claim 10. Final Act. 7 (citing Harrison ¶¶ 90,
142–151; Fig. 24). The Examiner provides no explanation regarding how
Harrison’s cited portions disclose this limitation. In the Answer, the
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Examiner cites a different paragraph of Harrison. Ans. 9 (citing Harrison
¶ 141). The entire explanation the Examiner provides in the Answer states:
Harrison teaches analyzing each protocol criteria and displaying
the top ten greatest impacts on patient eligibility. Harrison further
teaches that analysis of the criteria allows suggestions of
potential modifications to enhance study size, increase patient
enrollment, etc. (para. 141). Examiner states that the Harrison's
teaching of suggestion for potential modifications includes the
instructions on how to modify the criterion and adjust protocol
criteria.
Ans. 9.
Appellant argues the § 102 rejection of all claims as a group. See
Br. 23 (arguing “independent claim 15 recites similar elements to the
elements discussed with regard to independent claim 10” and, therefore,
independent claim 15 and dependent claims 11, 12, 14, 16, and 18–20 are
not anticipated by Harrison for the same reasons presented with respect to
claim 10). We select claim 10 as representative of the claims with respect to
the rejection of claims 10–12, 14–16, and 18–20 as anticipated by Harrison
under 35 U.S.C. § 102. See 37 C.F.R. § 41.37 (c)(1)(iv) (2016).
Appellant acknowledges that Harrison discloses analyzing a group of
patients eligible for a trial, referred to as a “patient cohort,” using multiple
criteria, presenting “a list that ranks the multiple clinical trial protocol
criteria by their respective impact on clinical trial eligibility within the
patient cohort,” and allowing a user to select and change different sets of
criteria to “‘work through various scenarios, determining the impact of
patient and physician eligibility based on various combinations.’” Br. 20–21
(citing Harrison ¶¶ 142–145, 149–151). Appellant argues, among other
things, that Harrison’s ranked list, however, does not include a “new
suggested value for modifying one of the ranked criteria” and “merely
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allowing a user to manually select different sets of multiple protocol criteria”
and work though different scenarios fails to disclose receiving a suggested
modification that includes a new suggested value, as required by claim 10.
Br. 21.
Harrison discloses that “[a]nalyzing each clinical trial criteria
individually [in relationship to the patient population] allows the system 100
to suggest potential modifications to enhance study size.” Harrison ¶ 141
(emphasis added). Harrison, therefore, discloses subject matter similar to
what is recited in claim 10’s disputed limitation, and Harrison achieves the
same goal recited in claim 10’s receiving step, which recites receiving a
suggested modification that includes “a new value with which to modify the
at least one of the plurality of value ranges . . . [and] wherein the new value
modifies the scope of the clinical-trial criterion by increasing the number of
patients eligible for the clinical trial.” Br. 27 (claim 10).
Harrison then discloses “they system 100 allows the sponsor to make
real-time modifications to the protocol criteria and see how each change
might influence the overall patient pool, predicted enrollment rates or
eligible physicians.” Harrison ¶ 141. This disclosure also describes similar
features to those recited in claim 10 in that Harrison discloses providing
information to a user regarding clinical-trial criteria and how modifications
to those criteria may affect the number of eligible patients.
We see nothing in Harrison’s cited portions that disclose providing a
suggestion that includes “a new value with which to modify the at least one
of the plurality of value ranges,” let alone a finding by the Examiner that
Harrison discloses this “new value.” We agree with the Examiner that
Harrison discloses (1) analyzing criteria, (2) displaying a ranked list of the
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criteria having the greatest impact on patient eligibility, and (3) suggesting
potential modifications that will enhance a study size. However, the
Examiner never identifies anything in particular in Harrison that discloses
the recited “new value.”
Whether these disclosures may suggest to a person of ordinary skill in
the art that Harrison provides “a new value” with which to modify value
ranges for one of the criteria is not before us because the Examiner does not
reject the claims as obvious in view of Harrison’s teachings. Given the
anticipation rejection before us, the Examiner’s findings are problematic. A
claim is anticipated only if each and every element as set forth in the claim is
found, either expressly or inherently described, in a single prior art
reference. Verdegaal Bros. v. Union Oil Co. of California, 814 F.2d 628,
631 (Fed. Cir. 1987). As stated, we see nothing in Harrison’s cited portions
that explicitly discloses a suggestion including a new value. Furthermore, to
rely upon inherency, the Examiner must show the inherent feature
necessarily exists; the fact that a certain result or characteristic may occur or
be present in the prior art is not sufficient to establish the inherency of that
result or characteristic. In re Rijckaert, 9 F.3d 1531, 1534 (Fed. Cir. 1993).
We are constrained by this record, for the reasons discussed above, to
reverse the Examiner’s rejection of representative claim 10 and independent
claim 15, which recites commensurate limitations. For the same reasons, we
reverse the Examiner’s rejection of dependent claims 11, 12, 14, 16, and 18–
20, which ultimately depend from one of claims 10 and 15 and incorporate
the limitations of the claims from which they depend.
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CONCLUSION
In summary:
Claims
Rejected
Basis Affirmed Reversed
10–12, 14–16, 18–20 § 101 10–12, 14–16, 18–20
10–12, 14–16, 18–20 § 102 Harrison 10–12, 14–
16, 18–20
Overall Outcome

10–12, 14–16, 18–20

AFFIRMED