Bruce Reiner

Patent Trials and Appeals Board

Dec 7, 2021

2021001016 (P.T.A.B. Dec. 7, 2021)

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.
12/213,184 06/16/2008 Bruce Reiner 71486.0062 9346
13155 7590 12/07/2021
Edwards Neils LLC
380 Maple Street
#8126
Gallatin, TN 37066
EXAMINER
COLEMAN, CHARLES P.
ART UNIT PAPER NUMBER
3626
NOTIFICATION DATE DELIVERY MODE
12/07/2021 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):
ipgeneral@edwardsneils.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte BRUCE REINER

Appeal 2021-001016
Application 12/213,184
Technology Center 3600
____________

Before MICHAEL C. ASTORINO, JAMES P. CALVE, and
MATTHEW S. MEYERS, Administrative Patent Judges.

MEYERS, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), the Appellant appeals from the
Examiner’s non-final decision to reject claims 2–21, 23–43, and 45–51,
which are all of the pending claims.1 We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM.

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies Dr. Bruce Reiner as the real party in
interest. Appeal Br. 2.
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CLAIMED INVENTION
Appellant’s claimed invention relates to a qualitative assurance
system that “quantitatively rates users that perform and/or participate in
medical procedures, particularly in the area of radiology.” Spec. ¶ 3.
Claims 2, 27, and 32 are the independent claims on appeal. Claim 2,
reproduced below, with modified formatting and bracketed notations, is
illustrative of the claimed subject matter.
2. A method of reducing radiation exposure risk to a patient,
comprising:
[a] performing at least one imaging study on the patient
using an imaging device;
[b] taking images during said at least one imaging study,
using said imaging device, during an imaging examination of the
patient;
[c] combining, using a merging module, said images of
said at least one imaging study with any other imaging studies on
the patient, in at least one database, with medical records on the
patient;
[d] assessing, using a metrics module the processing of
said images from said at least one imaging study with said
previous imaging studies, in combination with said medical
records of the patient;
[e] determining a radiation exposure of the patient from
previous imaging studies by at least extracting radiation
exposure parameters from previous imaging devices;
[f] determining a cumulative risk of radiation exposure of
the patient from said previous imaging studies and any additional
imaging studies;
[g] adjusting radiation exposure parameters on one or
more imaging devices during any said additional imaging studies
to reduce radiation levels, and thereby reduce said cumulative
risk of radiation exposure to the patient; and
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[h] creating a patient quality assurance score, using said
metrics module by assessment of said patient cumulative risk of
radiation exposure, said medical records, said imaging studies,
including said additional imaging studies, patient surveys, and
patient compliance with medical instructions, to measure at least
an effectiveness of a utilization of said imaging device to
increase patient radiation safety.
Appeal Br. 24–25 (Claim App.).
REJECTIONS
Claims 2, 16, 27, 32, and 40 stand rejected under 35 U.S.C. § 112
(pre-AIA), first paragraph, as failing to comply with the written description
requirement.
Claims 2–21, 23–43,2 and 45–51 stand rejected under 35 U.S.C. § 101
as being directed to a judicial exception without significantly more.
ANALYSIS
Written Description
The Examiner rejects independent claims 2, 27, and 32 as failing to
comply with the written description requirement because “[t]he subject
matter ‘adjusting radiation exposure levels/parameters’ is not properly
described in the application as filed.” Non-Final Act. 3. More particularly,
the Examiner determines that “[t]he [S]pecification does not describe how
imaging devices, merging modules and/or metrics modules, perform the

2 Claims 41 and 42 depend from independent claim 32, but do not recite the
same statutory class of invention as that recited by claim 32. We take the
change of statutory class to be typographical error. However, should
prosecution continue, the Examiner may wish to consider requiring the
appropriate correction.
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‘adjusting radiation exposure parameters on one or more imaging devices’
and ‘adjusting radiation exposure levels’ steps of claims 2, 16, 27, 32 and
40.” Id. at 4. According to the Examiner, at most Appellant’s Specification
“appears to support recommending radiation exposure levels/parameters
adjustment by way of a report (i.e. quality assurance score), or manual
radiation exposure levels/parameters adjustment by a human operator, or
recording of manual radiation exposure levels/parameters adjustment made
by a human operator.” Id. at 3. The Examiner rejects dependent claims 16
and 40 for the same reasons. Id. at 3–4.
Appellant responds that “the Examiner omits the description in the
[S]pecification of how the imaging device agent modules 216 gather data on
‘imaging device actions performed such as . . . imaging device parameter
adjustments.’” Appeal Br. 10 (emphases omitted) (citing Spec. ¶ 83).
Appellant also argues that support for the claim language of limitation [g] is
found in the Specification at paragraphs 118, 119, and 126. Appeal Br. 10–
12.
Based on these cited portions, Appellant argues that “the QA
scorecard program is reducing radiation exposure by either eliminating
redundant imaging studies or optimizing techniques and performing
radiation adjustment actions.” Appeal Br. 11 (emphases omitted).
Appellant explains that “[t]hese are not just ‘recommendations’ as the
Examiner has previously asserted, but the [S]pecification clearly states that
these optimizing techniques are actions that result in adjustments of
radiation levels or elimination of redundant imaging studies.” Id. (emphases
omitted).
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In response, the Examiner states that paragraph 83 of the Specification
“supports at most ‘gather[ing] imaging device monitoring data’ such as
‘imaging device parameter adjustments.’ There is no express recitation that
Appellant’s imaging device itself performs parameter adjustments in
response to the generation of a quality assurance (QA) scorecard (which
itself is mere data).” Ans. 3 (emphases omitted).
Whether a specification complies with the written description
requirement of 35 U.S.C. § 112, first paragraph (now 35 U.S.C. § 112(a)), is
a question of fact and is assessed on a case-by-case basis. See, e.g., Purdue
Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000) (citing
Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1561 (Fed. Cir. 1991)). The
disclosure, as originally filed, need not literally describe the claimed subject
matter (i.e., using the same terms or in haec verba) in order to satisfy the
written description requirement. But the specification must convey with
reasonable clarity to those skilled in the art that, as of the filing date,
Appellant was in possession of the claimed invention. See id.
Here, the Specification discloses that
imaging device agent modules 216 may gather image device
monitoring data based on user actions performed, such as user
login information; imaging modalities; parameters that are
selected to perform the imaging modalities, including motion
information, positioning information, exposure information,
artifact information, collimation information; number of times an
imaging exam is performed; data files and databases that are
accessed; information that is requested . . . and other user action
data.
Spec. ¶ 82. The Specification also discloses that
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imaging device agent modules 216 may gather imaging device
monitoring data based on imaging device actions performed,
such as when data is exchanged; the type of input device used;
whether reports are printed; when data was saved; an Internet
Protocol (IP) address of devices that were communicated with; a
location of data storage/retrieval; imaging device parameter
adjustments; and other imaging device data.
Id. ¶ 83. The Specification further discloses that
[b]y providing access to the patient’s records that are stored in
the information sources, such as the EMR and/or electronic
imaging folder, the QA scorecard program 110 provides users
with a tool for eliminating the occurrence of redundant exams.
According to one embodiment, eliminating redundant imaging
exams increases patient safety by subjecting the patient to less
radiation exposures and also saves costs by requiring fewer
imaging studies. According to one embodiment, the QA
scorecard program 110 may calculate QA metrics for eliminating
redundancy in a patient QA scorecard.
Id. ¶ 118. The Specification still further discloses that
patient exposure to radiation may be reduced by enabling the QA
scorecard program 110 to eliminate redundant imaging studies
that utilize, for example, ionizing radiation or other radiation
sources. According to one embodiment, patient exposure to
radiation may be reduced by enabling the QA scorecard program
110 to perform optimizing techniques that includes accessing
patient data from the information sources, extracting exposure
parameters and corresponding QA scores from all previous
imaging studies, and recommending adjustments to radiation
levels, among other actions.
Id. ¶ 119.
Based on these cited paragraphs, we agree with the Examiner that
“express support in Appellant’s Specification for Appellant’s allegation that
‘the imaging device itself performs the image device parameter
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adjustment[s]’” cannot be found in the cited portions of the Specification.
Ans. 3. Here, we note that Appellant’s Specification makes a distinction
between imaging device agent modules that “gather image device
monitoring data based on user actions performed” (e.g., parameters that are
selected to perform the imaging modalities, including exposure information
and number of times an imaging exam is performed) and imaging device
agent modules that “gather imaging device monitoring data based on
imaging device actions performed” (e.g., imaging device parameter
adjustments). Spec. ¶¶ 82–83. We also note that imaging device parameter
adjustments would not necessarily include radiation exposure parameter
adjustments. The Specification makes it clear that the optimizing techniques
include “accessing patient data from the information sources, extracting
exposure parameters and corresponding QA scores from all previous
imaging studies, and recommending adjustments to radiation levels.” Id.
¶ 119 (emphasis added).
We are not persuaded by Appellant’s assertion that “the QA scorecard
program is reducing radiation exposure by either eliminating redundant
imaging studies or optimizing techniques and performing radiation
adjustment actions” and that “[t]hese are not just ‘recommendations.’”
Appeal Br. 11 (emphases omitted). In addition to the paragraph cited above
regarding recommending adjustments to radiation levels, the QA scorecard
program is disclosed as “enabl[ing] users to assess redundancy of medical
imaging studies, which leads to excessive costs” (Spec. ¶ 108) and as
“provid[ing] users with a tool for eliminating the occurrence of redundant
exams.” Id. ¶ 118. Appellant argues that “there is no other interpretation of
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how the claims are read in context of the entire claim and of the entire
[S]pecification” and Appellant “is his own lexicographer here.” Appeal Br.
11. However, the Specification does not lexicographically define “actions”
or “recommendations.” Although Appellant may act as their own
lexicographer so as to assign a special definition to each claim term, that
definition must be “clearly set[] forth” and “explicit.” See Prima Tek II,
L.L.C. v. Polypap, S.A.R.L., 318 F.3d 1143, 1148 (Fed. Cir. 2003).
Appellant further argues that “the very fact that the computer’s actions
to reduce radiation levels at the image device can be ‘manually overridden’,
further emphasizes the fact that the actions taken by the computer are not
manually performed.” Appeal Br. 12 (citing Spec. ¶ 126) (emphases
omitted). However, the Specification discloses that “the QA scorecard
program 110 may recommend performing a requested CT examination
without intravenous contrast or performing ultrasound” and that “a specialist
may decide to override the QA scorecard program 110 recommendation and
add intravenous contrast to improve imaging information.” Spec. ¶ 126.
The paragraphs proffered by Appellant do not support “the computer’s
actions to reduce radiation levels at the image device,” but instead describe
providing a recommendation for adjusting a radiation level. Thus, we agree
with the Examiner that “adjusting radiation exposure parameters on one or
more imaging devices during any said additional imaging studies to reduce
radiation levels,” as recited by independent claims 2, 27, and 32, is not
reasonably disclosed or described in the Specification.
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Accordingly, we sustain the Examiner’s rejection of claims 2, 27, and
32 under 35 U.S.C. § 112 (pre-AIA), first paragraph. We sustain the
Examiner’s rejection of claims 16 and 40 for the same reasons.
Patent-Ineligible Subject Matter
Appellant argues claims 2–21, 23–43, and 45–51 as a group. Appeal
Br. 12–22. We select independent claim 2 as representative. The remaining
claims stand or fall with claim 2. See 37 C.F.R. § 41.37(c)(1)(iv).
35 U.S.C. § 101 Framework
Section 101
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 U.S. 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. Pty. Ltd. 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 Court’s two-part framework, described in Mayo and Alice.
Alice, 573 U.S. at 217–18 (citing Mayo Collaborative Servs. v. Prometheus
Labs., Inc., 566 U.S. 66, 75–77 (2012)). In accordance with that framework,
we first determine what concept the claim is “directed to.” See Alice, 573
U.S. at 219 (“On their face, the claims before us are drawn to the concept of
intermediated settlement, i.e., the use of a third party to mitigate settlement
risk.”); see also Bilski v. Kappos, 561 U.S. 593, 611 (2010) (“Claims 1 and 4
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in petitioners’ application explain the basic concept of hedging, or protecting
against risk.”).
Concepts determined to be abstract ideas, and thus patent ineligible,
include certain methods of organizing human activity, such as fundamental
economic practices (Alice, 573 U.S. at 219–20; Bilski, 561 U.S. at 611);
mathematical formulas (Parker v. Flook, 437 U.S. 584, 594–95 (1978)); and
mental processes (Gottschalk v. Benson, 409 U.S. 63, 67 (1972)). Concepts
determined to be patent eligible include physical and chemical processes,
such as “molding rubber products” (Diamond v. Diehr, 450 U.S. 175, 191
(1981)); “tanning, dyeing, making water-proof cloth, vulcanizing India
rubber, smelting ores” (id. at 182 n.7 (quoting Corning v. Burden, 56 U.S.
252, 267–68 (1853))); and manufacturing flour (Benson, 409 U.S. at 69
(citing Cochrane v. Deener, 94 U.S. 780, 785 (1876))).
In Diehr, the claim at issue recited a mathematical formula, but the
Court held that “a claim drawn to subject matter otherwise statutory does not
become nonstatutory simply because it uses a mathematical formula.”
Diehr, 450 U.S. at 187, 191 (“We view respondents’ claims as nothing more
than a process for molding rubber products and not as an attempt to patent a
mathematical formula.”). Having said that, the Court also indicated that a
claim “seeking patent protection for that formula in the abstract . . . is not
accorded the protection of our patent laws, and this principle cannot be
circumvented by attempting to limit the use of the formula to a particular
technological environment.” Id. at 187 (“It is now commonplace that an
application of a law of nature or mathematical formula to a known structure
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or process may well be deserving of patent protection.”), 191 (citing Benson
and Flook) (citation omitted).
If the claim is “directed to” an abstract idea, we turn to the second
step of the Alice and Mayo framework, where “we must examine the
elements of the claim to determine whether it contains an ‘inventive
concept’ sufficient to ‘transform’ the claimed abstract idea into a patent-
eligible application.” Alice, 573 U.S. at 221 (quotation marks omitted).
“A claim that recites an abstract idea must include ‘additional features’ to
ensure ‘that the [claim] is more than a drafting effort designed to
monopolize the [abstract idea].’” Id. (alterations in original) (quoting Mayo,
566 U.S. at 77). “[M]erely requir[ing] generic computer implementation[]
fail[s] to transform that abstract idea into a patent-eligible invention.” Id.
USPTO Section 101 Guidance
We are also guided by U.S. Patent and Trademark Office (“USPTO”)
Guidance, as set forth in the 2019 Revised Patent Subject Matter Eligibility
Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019) (“Guidance, 84 Fed. Reg.”),
incorporated into the MANUAL OF PATENT EXAMINING PROCEDURE
§§ 2104–06, Rev. 10.2019 (“MPEP”) in June 2020. “The guidance sets out
agency policy with respect to the USPTO’s interpretation of the subject
matter eligibility requirements of 35 U.S.C. [§] 101 in view of decisions by
the Supreme Court and the Federal Circuit.” Guidance, 84 Fed. Reg. at 51.3

3 In response to received public comments, the Office issued further
guidance on October 17, 2019, clarifying the 2019 Revised Guidance, 84
Fed. Reg. USPTO, October 2019 Update: Subject Matter Eligibility (the
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Although “[a]ll USPTO personnel are, as a matter of internal agency
management, expected to follow the guidance,” the Guidance “does not
create any right or benefit, substantive or procedural, enforceable by any
party against the USPTO.” Id. The Guidance, by its terms, applies to all
applications, and to all patents resulting from applications, filed before, on,
or after January 7, 2019. Id. at 50.
Under the USPTO Guidance and October 2019 Update, we first look
to whether the claim recites: (1) any judicial exceptions, including laws of
nature, natural phenomena, and products of nature (see MPEP
§§ 2106.04(II)(A)(1), 2106.04(b)) (“Step 2A, Prong One”); and
(2) additional elements that integrate the judicial exception into a practical
application (see id. §§ 2106.04(II)(A)(2), 2106.04(d)) (“Step 2A, Prong
Two”).4
Only if a claim (1) recites a judicial exception and (2) does not
integrate that exception into a practical application, do we then look, under
Step 2B, to whether the additional elements, individually or in combination,
provide an inventive concept. See MPEP §§ 2106(III), 2106.05. “An
inventive concept ‘cannot be furnished by the unpatentable law of nature (or

“October 2019 Update”) (available at https://www.uspto.gov/sites/default/
files/documents/peg_oct_2019_update.pdf).
4 This evaluation is performed by (a) identifying whether there are any
additional elements recited in the claim beyond the judicial exception, and
(b) evaluating those additional elements individually and in combination to
determine whether the claim as a whole integrates the exception into a
practical application, as the term is used in USPTO Guidance. See Guidance
— Section III(A)(2), 84 Fed. Reg. at 54–55; MPEP § 2106.04(d).
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natural phenomenon or abstract idea) itself.’” Id. § 2106.05 (quoting
Genetic Techs. Ltd. v. Merial L.L.C., 818 F.3d 1369, 1376 (Fed. Cir. 2016)).
Among the considerations in determining whether the additional elements,
individually or in combination, amount to significantly more than the
exception itself, we look to whether they add a specific limitation beyond the
judicial exception that is not “well-understood, routine, conventional” in the
field or simply append well-understood, routine, conventional activities
previously known to the industry, specified at a high level of generality, to
the judicial exception. MPEP § 2106.05(II); Guidance, 84 Fed. Reg. at 56.
Step One of the Mayo/Alice Framework
Under the first step of the Mayo/Alice framework and Step 2A, Prong
One of USPTO Guidance, the Examiner determines that exemplary
independent claim 2 recites broadly “taking images, combining images,
assessing images, determining radiation exposures, determining cumulative
risks, adjusting radiation exposure parameters, creating patient quality
assurance scores.” Non-Final Act. 5. The Examiner characterizes the steps
recited by claim 2 as “a method of managing personal behavior or
relationships or interactions between people (social activities, teaching,
following rules, instructions) and thus grouped as a certain method of
organizing human interactions.” Id. (emphases omitted). Under Prong Two
of the USPTO Guidance, the Examiner determines that the identified judicial
exception is not integrated into a practical application “because the
generically recited additional computer elements . . . amount to simply
implementing the abstract idea on a computer.” Id.
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In response, Appellant asserts that the Examiner is incorrect in
determining that the claims are directed to an abstract idea. Appeal Br. 12.
According to Appellant, “the present invention requires that radiation
exposure risk caused by multiple imaging examinations (i.e., x-rays, MRI’s,
etc.) performed on a patient, be quantified for radiation levels, to reduce the
risk of future health issues, e.g., cancerous tumors, to the patient.” Id. at 13.
Appellant argues that the claims
do not merely present the “results of abstract processes of
collecting and analyzing information”, but provide significantly
more, such as identifying particular tools which are used (i.e.,
imaging device, metrics module, merging module, etc.), to
achieve a “specific improvement,” which is ensuring that a
patient is not exposed unnecessarily to excessive radiation with
its consequential health risk.
Id. at 14.
Under the first step of the Mayo/Alice framework and Step 2A of the
USPTO Guidance, we first determine to what claim 2 is directed, i.e.,
whether claim 2 recites an abstract idea and if so, whether claim 1 is directed
to that abstract idea. The Federal Circuit has explained that “the ‘directed
to’ inquiry applies a stage-one filter to claims, considered in light of the
specification, based on whether ‘their character as a whole is directed to
excluded subject matter.’” Enfish, LLC v. Microsoft Corp., 822 F.3d 1327,
1335 (Fed. Cir. 2016) (quoting Internet Patents Corp. v. Active Network,
Inc., 790 F.3d 1343, 1346 (Fed. Cir. 2015)). It asks whether the focus of the
claim is on a specific improvement in relevant technology or on a process
that itself qualifies as an “abstract idea” for which computers are invoked
merely as a tool. See id. at 1335–36. Here, it is clear from the Specification,
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including the claim language, that claim 2 focuses on an abstract idea, and
not on any improvement to technology and/or a technical field.
Reciting a Judicial Exception
In making this determination, we note that the Specification is titled
“METHOD AND APPARATUS FOR GENERATING A PATIENT
QUALITY ASSURANCE SCORECARD,” and states that the disclosure
relates to a quality assurance (QA) system that “quantitatively rates users
that perform and/or participate in medical procedures, particularly in the area
of radiology.” Spec. ¶ 3. The Specification states that,
[t]he first and foremost priority for any QA program is to
improve quality of service. As QA programs are implemented in
the medical field, the ultimate goal is to improve patient care. To
accomplish this goal, products and/or services should offer
procedures for increasing accountability and improving feedback
among users that participate in a medical study.
Id. ¶ 4. The Specification acknowledges that
[d]igital imaging technologies provide digital processing
capabilities, such as image capture, image archive, image
transfer, and image display that may be shared among users to
the medical study. Digital imaging technologies further allow
data that is associated with the digital processing operations to
be captured and combined with the underlying digital imaging
processing operations.
Id. ¶ 5. According to the Specification, “a need exists to leverage digital
imaging technologies to increase accountability and improve feedback
among users that participate in a medical study.” Id. ¶ 6.
To address this need, the present invention provides a QA scorecard
“framework for developing a comprehensive medical imaging QA program
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that defines objective benchmarks.” Spec. ¶ 7. The Specification describes
that “medical studies are performed by users that perform discrete tasks in
an imaging study workflow sequence,” and that
[a] typical workflow sequence includes imaging exam ordering,
imaging exam scheduling, imaging exam acquisition, imaging
exam processing, imaging exam archiving, imaging exam
distribution, imaging exam display, imaging exam navigation,
imaging exam interpretation, imaging exam reporting,
communication and billing, among other sequences.
Id. ¶ 8.
Consistent with this disclosure, independent claim 2 recites “[a]
method of reducing radiation exposure risk to a patient” including steps for
collecting data, i.e., “performing at least one imaging study on the patient”
(limitation [a]); “taking images during said at least one imaging study”
(limitation [b]); “combining, using a merging module, said images of said at
least one imaging study” (limitation [c]); analyzing data, i.e., “assessing,
using a metrics module the processing of said images from said at least one
imaging study with said previous imaging studies” (limitation [d]);
“determining a radiation exposure of the patient” (limitation [e]);
“determining a cumulative risk of radiation exposure of the patient”
(limitation [f]); manipulating (i.e., updating or recommending) data, i.e.,
“adjusting radiation exposure parameters on one or more imaging devices”
(limitation [g]); and analyzing and outputting additional data, i.e., “creating
a patient quality assurance score” (limitation [h]). Appeal Br. 24–25 (Claim
App.).
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When considered collectively and under the broadest reasonable
interpretation, we agree with the Examiner that claim 2, as summarized
above, recites broadly a system for “analyzing data and generating QA
scorecards” (Ans. 4–6) by a series of steps for collecting, analyzing, and
manipulating data with the result of reducing radiation exposure risk to a
patient and providing a quality assurance score which may be characterized
in the form of certain methods of organizing human activities, i.e.,
“managing personal behavior or relationships or interactions between people
(including . . . following rules or instructions).”5 Guidance, 84 Fed. Reg. at
52; MPEP § 2106.04(a)(2)(II).6 As such, we are unpersuaded by
Appellant’s assertion that the present claims “do not merely present the
‘results of abstract processes of collecting and analyzing information’, but
provide significantly more, such as identifying particular tools which are
used (i.e., imaging device, metrics module, merging module, etc.), to
achieve a ‘specific improvement.’” Appeal Br. 14. As discussed more fully
below with respect to Prong Two, simply reciting an “imaging device,”
“merging module,” and “metrics module” does not change the result that the
claim recites an abstract idea. At best, the specific physical elements

5 We note that “[a]n abstract idea can generally be described at different
levels of abstraction.” Apple, Inc. v. Ameranth, Inc., 842 F.3d 1229, 1240
(Fed. Cir. 2016). The Board’s “slight revision of its abstract idea analysis
does not impact the patentability analysis.” Id. at 1241.
6 We also agree with the Examiner that claim 2 may be characterized as
falling under the category of “[m]ental processes—concepts performed in
the human mind (including an observation, evaluation, judgment, opinion).”
Guidance, 84 Fed. Reg. at 52; MPEP § 2106.04(a)(2)(III). Ans. 5–6.
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“limit[] the invention to a technological environment for which to apply the
underlying abstract concept.” Intellectual Ventures I LLC v. Capital One
Fin. Corp., 850 F.3d 1332, 1340 (Fed. Cir. 2017) (“Capital One Fin.”).
Collecting, analyzing, and manipulating data, and generating QA
scorecards is similar to the concepts found abstract in University of Florida
Research Foundation, Inc. v. General Electric Co., 916 F.3d 1363, 1366–68
(Fed. Cir. 2019) (Claim for standardizing data to be conveyed to a bedside
device for graphical display was directed to the abstract idea of “collecting,
analyzing, manipulating, and displaying data.”), BSG Tech LLC v.
Buyseasons, Inc., 899 F.3d 1281, 1286 (Fed. Cir. 2018) (“considering
historical usage information while inputting data”), Electric Power Group,
LLC v. Alstom S.A., 830 F.3d 1350, 1351–54 (Fed. Cir. 2016) (Claim for
detecting events by receiving, detecting, analyzing, displaying,
accumulating, and updating data, and deriving a composite indicator from
that data was directed to the abstract idea of “collecting information,
analyzing it, and displaying certain results of the collection and analysis.”),
and In re Salwan, 681 F. App’x 938, 941 (Fed. Cir. 2017) (nonprecedential)
(claims to storing, communicating, transferring, and reporting patient health
information in a network held as an abstract idea of billing insurance
companies and organizing patient health information).
Having concluded that claim 2 recites a judicial exception under the
Guidance, Step 2A, Prong One, we next consider whether the claim recites
additional elements that integrate the judicial exception into a practical
application.
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Integration into a Practical Application
We look to whether the claim “appl[ies], rel[ies] on, or use[s] the
judicial exception in a manner that imposes a meaningful limit on the
judicial exception, such that the claim is more than a drafting effort designed
to monopolize the judicial exception,” i.e., “integrates a judicial exception
into a practical application.” Guidance, 84 Fed. Reg. at 54; MPEP
§ 2106.04(d). Here, the only additional elements recited in claim 2, i.e.,
elements beyond the abstract idea, are the “imaging device,” “merging
module,”7 and “metrics module”8 — elements that, as the Examiner
observes, are “merely tools used by Appellant to implement data
processing.” Ans. 6. Appellant asserts that
the present invention is directed to additional elements (i.e.,
imaging device, metrics module, merging module, adjusting the
imaging device parameters based on the results of the metrics
module) which give effect to a particular treatment or medical
condition (i.e., reducing patient radiation exposure from imaging
devices), used with a particular machine (i.e., imaging device),
and which provides information such that the present invention
is more than a “drafting effort designed to monopolize the

7 The Examiner finds “merging module” to invoke 35 U.S.C. § 112 (pre-
AIA), sixth paragraph (Non-Final Act. 4). Appellant’s Summary of Claimed
Subject Matter directs attention to paragraphs 20 and 84 of the Specification
to address this limitation.
8 The Examiner finds “metrics module” to invoke 35 U.S.C. § 112 (pre-
AIA), sixth paragraph (Non-Final Act. 4). Appellant’s Summary of Claimed
Subject Matter directs attention to paragraphs 97 and 98 of the Specification
to address this limitation.

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exception” (see the 2019 Revised Patent Subject Matter
Eligibility Guidance).
Appeal Br. 16–17 (emphasis omitted).
However, we disagree with Appellant’s assertion. Here, we note that
the Specification describes that “the server may include a merging module
that receives data from all devices that are networked to the server,” and that
“the merging module merges data that is captured during a medical
examination, including user action data, client computer action data,
imaging device action data, and other data.” Spec. ¶ 20. The Specification
also describes that the merging module “may locally store the received data
in a storage device 260 and/or may store the received data in an external
storage device.” Id. ¶ 84. The Specification further discloses “metrics
module 232 for performing prospective and retrospective trending analysis”
and “metrics module 232 may automatically tally and record QA scores in a
selected database.” Id. ¶¶ 97–98. Thus, Appellant’s conclusory assertions
that the merging and metrics modules are “unique module[s] programmed
for unique operations by the inventor” (Appeal Br. 13) fail to provide
persuasive evidence that the programming related to each of their process
steps entails anything atypical from conventional programming.
As is clear from the Specification, there is no indication that the
processes recited in claim 2 require any specialized computer hardware or
other inventive computer components, i.e., a particular machine, invoke any
asserted inventive programming, or that the claimed invention is
implemented using anything other than generic computer components to
perform generic computer functions. See DDR Holdings, LLC v.
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Hotels.com, L.P., 773 F.3d 1245, 1256 (Fed. Cir. 2014) (“[A]fter Alice, there
can remain no doubt: recitation of generic computer limitations does not
make an otherwise ineligible claim patent-eligible.”).
Instead, independent claim 2, unlike the claims found non-abstract in
prior cases, uses generic computer technology to collect, analyze, and
manipulate data for the purposes of reducing radiation exposure risk and
measuring an effectiveness of a utilization of an imaging device, and does
not recite an improvement to a particular computer technology. See, e.g.,
Spec. ¶ 53 (“[S]erver 120 may include a processor 121 having a CPU 122 or
parallel processor, which may be a server data processing device and an I/O
interface 123.”); see also Spec. ¶¶ 41, 54, 56–61, 64, 66–68. Cf. McRO, Inc.
v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314–15 (Fed. Cir. 2016)
(Finding claims not abstract because they “focused on a specific asserted
improvement in computer animation.”). We also find no indication in the
Specification that the claimed invention as recited in claim 2 effects a
particular treatment or prophylaxis for a disease or medical condition.
Appellant further argues that
The step of adjusting the radiation exposure parameters
during the imaging examination on an imaging device, based on
the results determined by the merging module and metrics
module[] . . . [is] not [a] step[] that can be performed by the
human mind, and [is] not [a] simple abstraction, but rather, [is]
directed to specific steps using tangible devices, performed by
novel means – which make them more than a simple abstract
idea.
Appeal Br. 14 (emphases omitted). Appellant explains that “the adjustment
takes place automatically by the imaging device.” Id. at 20 (emphases
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omitted). However, we find the step of adjusting the radiation exposure
parameters to be similar to patent ineligible concepts such as adjusting an
alarm limit to an updated alarm limit as in Flook, 437 U.S. at 584 (holding
ineligible a method for updating an alarm limit on a process variable, despite
the process involving the catalytic chemical conversion of hydrocarbons);
comparing new and stored information and using rules to identify options as
in SmartGene, Inc. v. Advanced Biological Labs., SA, 555 F. App’x 950
(Fed. Cir. 2014); tracking financial transactions to determine whether they
exceed a pre-set spending limit (i.e., budgeting) as in Intellectual Ventures I
LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367 (Fed. Cir. 2015). The
step Appellant relies on is part of the abstract idea, which cannot integrate
that abstract idea into a practical application. Under Step 2A, Prong Two,
“examiners evaluate whether the claim recites additional elements that
integrate the exception into a practical application of that exception.”
Guidance, 84 Fed. Reg. at 54. As such, features of the abstract idea cannot
be relied upon to integrate itself into a practical application. See id. at 55
n.24 (USPTO guidance uses the term “additional features” to refer to claim
features beyond the identified abstract idea).
Appellant asserts that “the present claims exhibit patent-eligibility
since the claims focus on a specific means or method that improves the
quality of patient care with an improvement in the treatment of patients
during imaging examinations.” Appeal Br. 20. However, the focus of
independent claim 2 is not on any technological advancement to the way
computers operate, or an imaging device operates; but rather, on the
implementation of the abstract idea, “for which computers are invoked
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merely as a tool.” See Enfish, 822 F.3d at 1336. Here, the claimed process
of reducing radiation exposure risk to a patient by collecting, analyzing, and
manipulating information is recited without any technological details on how
the steps are performed technologically other than using a conventional
image device and a conventional computer in its ordinary capacity to
perform data analysis. See, e.g., Spec. ¶¶ 16, 53–54. Any improvement in
the quality of patient care or treatment of patients during imaging
examinations is not a technical or technological improvement; but rather a
business improvement. See, e.g., id. ¶¶ 99, 101, 103, 108–109. OIP Techs.,
Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363 (Fed. Cir. 2015) (Holding
that claims are directed to “the abstract idea of offer-based price
optimization.”); Enfish, 822 F.3d at 1336 (Focusing on whether the claim is
“an improvement to [the] computer functionality itself, not on economic or
other tasks for which a computer is used in its ordinary capacity.”). See also
Bridge & Post, Inc. v. Verizon Commc’ns, Inc., 778 F. App’x 882, 893 (Fed.
Cir. 2019) (“The ability to run a more efficient advertising campaign, even if
novel, and even if aided by conventional computers, is an advance ‘entirely
in the realm of abstract ideas,’ which we have repeatedly held to be
ineligible.”).
Thus, we are not persuaded of error in the Examiner’s determination
that the additional elements of claim 2 do not integrate the judicial exception
into a practical application, as the term is used in USPTO Guidance, and we
are not persuaded of error in the Examiner’s determination that claim 2 is
directed to an abstract idea.
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Step Two of the Mayo/Alice Framework
Under the second step in the Alice framework and USPTO Guidance
Step 2B, we “[e]valuat[e] additional elements to determine whether they
amount to an inventive concept [which] requires considering them both
individually and in combination to ensure that they amount to significantly
more than the judicial exception itself.” MPEP § 2106.05(I). Here, the
Examiner determines
[t]he claims do not include additional elements that are sufficient
to amount to significantly more than the judicial exception
because the additional limitations (i.e., processor, etc.) only store
and retrieve information, and these are well-understood, routine,
conventional computer functions.
Non-Final Act. 5 (citing MPEP § 2106.05(d)(II)). We agree with the
Examiner. See also Elec. Power, 830 F.3d at 1355 (gathering, sending,
monitoring, analyzing, selecting, and presenting information does not
transform the abstract process into a patent-eligible invention); OIP Techs,
788 F.3d at 1363 (noting that storing data is well-understood, routine, and
conventional and does not render claims eligible); In re TLI Commc’ns LLC
Patent Litig., 823 F.3d 607, 613 (Fed. Cir. 2016) (“[T]he claims’ recitation
of a ‘telephone unit,’ a ‘server’, an ‘image analysis unit,’ and a ‘control unit’
fail to add an inventive concept sufficient to bring the abstract idea into the
realm of patentability”).
In response, Appellant argues that
the steps recited “go beyond ‘well-understood, routine,
conventional activit[ies]’ and render the invention patent-
eligible” (see Bascom [Glob. Internet Servs., Inc. v. AT&T
Mobility LLC, 827 F.3d 1341 (Fed. Cir. 2016)]), since there is no
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existing system or method which allows radiation risk exposure
to be reduced during an imaging examination by adjusting the
parameters on the image device(s).
Appeal Br. 18 (emphases omitted). However, an abstract idea does not
transform into an inventive concept just because the prior art does not
disclose or suggest it. See Mayo, 566 U.S. at 78. Indeed, “[t]he ‘novelty’ of
any element or steps in a process, or even of the process itself, is of no
relevance in determining whether the subject matter of a claim falls within
the § 101 categories of possibly patentable subject matter.” Diehr, 450 U.S.
at 188–89; see also Mayo, 566 U.S. at 91 (rejecting “the Government’s
invitation to substitute §§ 102, 103, and 112 inquiries for the better
established inquiry under § 101”).
We are not persuaded, on the present record, that the Examiner erred
in rejecting independent claim 2 under 35 U.S.C. § 101. Therefore, we
sustain the Examiner’s rejection of independent claim 2, and claims 3–21,
23–43, and 45–51, which fall with independent claim 2.
Rejection of claims 32–43, 45, 47, 49, and 51 under
35 U.S.C. § 101 as being directed to signals
In rejecting independent claim 32, the Examiner finds claim 32 is also
directed to non-statutory subject matter because a computer readable
medium “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.” Non-Final Act. 6–7. See also Spec. ¶ 64.
Appellant does not challenge the Examiner’s rejection. See generally
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Appeal Br. Therefore, the rejection under 35 U.S.C. § 101 as being directed
to signals is summarily sustained.
CONCLUSION
In summary:

Claim(s)
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
2, 16, 27, 32,
40
112, first
paragraph
Written
Description
2, 16, 27, 32,
40

2–21, 23–43,
45–51
101 Eligibility 2–21, 23–43,
45–51

Overall
Outcome
2–21, 23–43,
45–51

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED