ORACLE INTERNATIONAL CORPORATION

Patent Trials and Appeals Board

Feb 11, 2020

13886719 - (D) (P.T.A.B. Feb. 11, 2020)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/886,719 05/03/2013 William H. DUMOUCHEL 2011-0031US01 6246
74739 7590 02/11/2020
Potomac Law Group, PLLC (Oracle International)
8229 Boone Boulevard
Suite 430
Vienna, VA 22182
EXAMINER
KNOX, TYLER W
ART UNIT PAPER NUMBER
3624
NOTIFICATION DATE DELIVERY MODE
02/11/2020 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
bgoldsmith@potomaclaw.com
eofficeaction@appcoll.com
patents@potomaclaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte WILLIAM H. DUMOUCHEL and ROBERT WEBER
____________

Appeal 2019-002136
Application 13/886,719
Technology Center 3600
____________

Before NINA L. MEDLOCK, PHILIP J. HOFFMANN, and
BRUCE T. WIEDER, Administrative Patent Judges.

MEDLOCK, Administrative Patent Judge.

DECISION ON APPEAL

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STATEMENT OF THE CASE
Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner’s
final rejection of claims 1, 4, 6, 7, 10, 12, 13, 16, and 18–24.2 We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
CLAIMED INVENTION
Appellant’s claimed invention relates “generally to a computer
system, and in particular to a computer system that estimates risk for
inspection sites” (Spec. ¶ 1).
Claims 1, 7, and 13 are the independent claims on appeal. Claim 1,
reproduced below with bracketed notations added, is illustrative of the
claimed subject matter:
1. A non-transitory computer readable medium having
instructions stored thereon that, when executed by a processor,
cause the processor to schedule compliance inspections by a
pharmacovigilance team of pharmaceutical product
manufacturing sites based on risk scores, the scheduling
comprising:

1 We use the term “Appellant” to refer to “applicant” as defined in 37 C.F.R.
§ 1.42. Our decision references Appellant’s Appeal Brief (“Appeal Br.,”
filed September 4, 2018) and Reply Brief (“Reply Br.,” filed January 16,
2019), and the Examiner’s Answer (“Ans.,” mailed November 16, 2018) and
Final Office Action (“Final Act.,” mailed February 22, 2018). Appellant
identifies Oracle International Corporation as the real party in interest.
Appeal Br. 2.
2 Appellant filed an Amendment After Final on April 20, 2018. That
Amendment would have canceled claims 6, 12, and 18. However, the
Examiner declined to enter the Amendment. See Advisory Action mailed
May 16, 2018. The Claim Appendix, included in the Appeal Brief, is
incorrect in its identification of claims 6, 12, and 18 as canceled.
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[(a)] receiving data relating to a plurality of
pharmaceutical product manufacturing sites, each
pharmaceutical product manufacturing site having a
corresponding management entity, wherein
each compliance inspection is an internal audit
conducted by the pharmacovigilance team and comprises,
at the pharmaceutical product manufacturing site, at least
one of reviewing documents, reviewing quality records,
examining facilities, examining assets, conducting tests,
or taking measurements, and
the data comprises, for each of the pharmaceutical
product manufacturing sites, unobserved risk parameters,
a plurality of previous compliance inspection results at the
pharmaceutical product manufacturing site including
observed inspection data, and observed data for the
corresponding management entity;
[(b)] estimating a plurality of hyper-parameters based on
the data, the hyper-parameters determining assumed prior
probabilistic relationships among the unobserved risk
parameters;
[(c)] for each of the pharmaceutical product
manufacturing sites, determining a risk score that corresponds to
expected deficiencies that would be found if the pharmaceutical
product manufacturing site was inspected, wherein a poor risk
score corresponds to a higher risk of having deficiencies, and at
least one previous deficiency identified by the plurality of
previous compliance inspection results at the pharmaceutical
product manufacturing site worsens the determined risk score for
the pharmaceutical product manufacturing site based, at least in
part, upon an amount of time that has elapsed since the previous
deficiency was identified; and
[(d)] scheduling the compliance inspections of the
pharmaceutical product manufacturing sites by the
pharmacovigilance team based on the determined risk score,
wherein pharmaceutical product manufacturing sites that have a
higher estimated level of risk are scheduled before
pharmaceutical product manufacturing sites that have a lower
estimated level of risk,
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wherein the risk score is based on a statistical model
comprising a relationship between the unobserved risk
parameters for the pharmaceutical product manufacturing
site, the observed inspection data for the pharmaceutical
product manufacturing site, and the observed data for the
corresponding management entity of the pharmaceutical
product manufacturing site, the risk score having a
binomial distribution with a mean exp(θisq), and
wherein the statistical model includes a logistic
regression relationship between observed events and risk
parameters that is given by:
P(Yisqk=1) = 1/[1 + exp(ak – bk θisq)],
where P() indicates a probability function,
where Yisqk indicates a presence or absence of a particular
event k at a particular time period q relating to a particular
management entity i and pharmaceutical product manufacturing
site s,
where θisq are the unobserved risk parameters for
pharmaceutical product manufacturing site i,
where i=1, . . ., C; where C is a total number of
management entities,
where s=1, . . ., Si; where Si is a total number of
pharmaceutical product manufacturing sites for management
entity i,
where q=1, . . ., Q; where Q is a total number of time
periods,
where k=1, . . ., K; where K is a total number of events,
and
where ak and bk are estimated logistic coefficients for
event k.
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REJECTION3
Claims 1, 4, 6, 7, 10, 12, 13, 16, and 18–24 are rejected under
35 U.S.C. § 101 as directed to a judicial exception without significantly
more.
ANALYSIS
Under 35 U.S.C. § 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. The Supreme Court, however, has long interpreted § 101
to include an implicit exception: “[l]aws of nature, natural phenomena, and
abstract ideas” are not patentable. Alice Corp. v. CLS Bank Int’l, 573 U.S.
208, 216 (2014).
The Supreme Court, in Alice, reiterated the two-step framework
previously set forth in Mayo Collaborative Services v. Prometheus
Laboratories, Inc., 566 U.S. 66 (2012), “for distinguishing patents that claim
laws of nature, natural phenomena, and abstract ideas from those that claim
patent-eligible applications of those concepts.” Alice Corp., 573 U.S. at 217.
The first step in that analysis is to “determine whether the claims at issue are
directed to one of those patent-ineligible concepts.” Id. If the claims are not
directed to a patent-ineligible concept, e.g., an abstract idea, the inquiry
ends. Otherwise, the inquiry proceeds to the second step where the elements
of the claims are considered “individually and ‘as an ordered combination’”
to determine whether there are additional elements that “‘transform the
nature of the claim’ into a patent-eligible application.” Id. (quoting Mayo,
566 U.S. at 79, 78). This is “a search for an ‘inventive concept’ — i.e., an

3 The Examiner has withdrawn the rejection of claims 1, 4, 6, 7, 10, 12, 13,
16, and 18–24 under 35 U.S.C. § 103. Ans. 3.
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element or combination of elements that is ‘sufficient to ensure that the
patent in practice amounts to significantly more than a patent upon the
[ineligible concept] itself.’” Id. at 217–18 (alteration in original).
In rejecting the pending claims under 35 U.S.C. § 101, the Examiner
determined that the claims are directed to scheduling compliance inspections
of pharmaceutical product manufacturing sites based on a determined risk
score that is calculated based on a statistical model, i.e., to a method of
organizing human activity and a mathematical relationship/formula, and,
therefore, to an abstract idea similar to other concepts that the courts have
held abstract (Final Act. 11–18). The Examiner also determined that the
claims do not include additional elements or a combination of elements
sufficient to amount to significantly more than the abstract idea itself (id.
at 18–23).
After Appellant’s Appeal Brief was filed, and the Examiner’s Answer
mailed, the U.S. Patent and Trademark Office (the “USPTO”) published
revised guidance for use by USPTO personnel in evaluating subject matter
eligibility under 35 U.S.C. § 101. 2019 REVISED PATENT SUBJECT MATTER
ELIGIBILITY GUIDANCE, 84 Fed. Reg. 50, 57 (Jan. 7, 2019) (the “2019
Revised Guidance”). That guidance revised the USPTO’s examination
procedure with respect to the first step of the Mayo/Alice framework by
(1) “[p]roviding groupings of subject matter that [are] considered an abstract
idea”; and (2) clarifying that a claim is not “directed to” a judicial exception
if the judicial exception is integrated into a practical application of that
exception. Id. at 50. The 2019 Revised Guidance, by its terms, applies to all
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applications, and to all patents resulting from applications, filed before, on,
or after January 7, 2019. Id.4,5
Independent Claim 1 and Dependent Claims 4, 19, and 21
Step One of the Mayo/Alice Framework (2019 Revised Guidance,
Step 2A)
The first step in the Mayo/Alice framework, as mentioned above, is to
determine whether the claims at issue are “directed to” a patent-ineligible
concept, e.g., an abstract idea. Alice Corp., 573 U.S. at 217. This first step,
as set forth in the 2019 Revised Guidance (i.e., Step 2A), is a two-prong test;
in Step 2A, Prong One, we look to whether the claim recites a judicial
exception, e.g., one of the following three groupings of abstract ideas:
(1) mathematical concepts; (2) certain methods of organizing human
activity, e.g., fundamental economic principles or practices, commercial or
legal interactions; and (3) mental processes. 2019 Revised Guidance,
84 Fed. Reg. at 54. If so, we next consider whether the claim includes
additional elements, beyond the judicial exception, that “integrate the
[judicial] exception into a practical application,” i.e., that apply, rely on, or

4 The 2019 Revised Guidance supersedes MANUAL OF PATENT EXAMINING
PROCEDURE (“MPEP”) § 2106.04(II) and also supersedes all versions of the
USPTO’s “Eligibility Quick Reference Sheet Identifying Abstract Ideas.”
See 2019 Revised Guidance, 84 Fed. Reg. at 51 (“Eligibility-related
guidance issued prior to the Ninth Edition, R-08.2017, of the MPEP
(published Jan. 2018) should not be relied upon.”). Accordingly,
Appellant’s arguments challenging the sufficiency of the Examiner’s
rejection will not be addressed to the extent those arguments are based on
currently-superseded USPTO guidance.
5 The USPTO issued an update on October 17, 2019 (the “October 2019
Update: Subject Matter Eligibility,” available at https://www.uspto.gov/sites/
default/files/documents/peg_oct_2019_update.pdf) clarifying the
2019 Revised Guidance in response to comments solicited from the public.
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use 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 (“Step 2A, Prong Two”). Id. at 54–55.
Only if the claim (1) recites a judicial exception and (2) does not integrate
that exception into a practical application do we conclude that the claim is
“directed to” the judicial exception, e.g., an abstract idea. Id.
We are not persuaded by Appellant’s arguments that the Examiner
erred in determining that claim 1 is directed to an abstract idea (Appeal
Br. 8–17). 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 claims 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 (including
the claim language) that the claims focus on an abstract idea, and not on any
improvement to technology and/or a technical field.
The Specification is titled “RISK ESTIMATION OF INSPECTION
SITES,” and states that one embodiment is directed, in particular, to a
computer system that estimates risk for inspection sites (Spec. ¶ 1). The
Specification describes, in the Background section, that an inspection (also
referred to as an audit) is generally understood as an organized examination
or evaluation conducted at a site, and may involve the review of documents
and quality records, the conducting of various tests, and/or the taking of
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various measurements (id. ¶ 2). Such an inspection may be conducted, for
example, to ensure that a site complies with established regulations and/or
standards, to regulate the quality of goods produced or services performed at
the site, to ensure that proper manufacturing methods are performed at the
site, to ensure that contaminants are properly controlled at the site, to ensure
that safe working conditions exist at the site, or to ensure that waste
materials are properly disposed of (id.). When a site fails to meet the
regulations and/or standards that pertain to an inspection, and, thus, fails
inspection, the inspection typically describes specific deficiencies, i.e., the
“findings” of the inspection, which contributed to the failure (id. ¶ 4).
The Specification describes that known inspection systems generally
schedule inspections by listing the sites to be inspected, sequentially
inspecting each listed site from a first site to a last site, and then conducting
subsequent rounds of inspection, again starting with the first site and ending
at the last site (id. ¶ 11). These previous approaches “generally did not
schedule inspections for sites based on any determined risk score that
corresponds to expected deficiencies that would result”; instead, the
Specification describes that previous approaches scheduled site inspections
based on “historic estimates of risk at the time of the previous inspections, as
opposed to using any systematic analysis of data” (id.). “For example, the
previous approaches generally would, at most, estimate the risk that a
specific site will fail an inspection based upon an immediately preceding
inspection result for the specific site”; a specific site would, therefore, be
deemed to have higher risk of failing inspection if the site failed the
immediately preceding inspection (id.).
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In contrast to the previous approaches, the Specification describes that
one embodiment of the present invention estimates the risk that a particular
site will have deficiencies by determining a risk score (corresponding to the
expected deficiencies) based on a systematic data analysis, e.g., by
examining: (1) a plurality of previous inspection results of the site, (2) site
self-assessment results and other information collected about the site or its
company, (3) the amount of time that has elapsed since previous inspections,
(4) potential correlations of risk that may exist among other sites that are
governed by the same management, and (5) a totality of risk information for
companies and sites for the respective industry or regulated area in the
inspection program (id. ¶ 12). These estimates are then used to give greater
priority for future inspections to sites that are determined to be at high risk
for poor risk scores (id. ¶ 20).
Consistent with this disclosure, claim 1 recites a non-transitory
computer readable medium having instructions stored thereon that, when
executed by a processor, cause the processor to schedule compliance
inspections of pharmaceutical product manufacturing sites based on risk
scores, the scheduling comprising: (1) receiving data relating to a plurality
of pharmaceutical product manufacturing sites, including, for each of the
manufacturing sites, unobserved risk parameters, a plurality of previous
compliance inspection results at the site including observed inspection data,
and observed data for the site’s management entity, i.e.,
receiving data relating to a plurality of pharmaceutical
product manufacturing sites, each pharmaceutical product
manufacturing site having a corresponding management entity,
wherein
each compliance inspection is an internal audit
conducted by the pharmacovigilance team and comprises,
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at the pharmaceutical product manufacturing site, at least
one of reviewing documents, reviewing quality records,
examining facilities, examining assets, conducting tests,
or taking measurements, and
the data comprises, for each of the pharmaceutical
product manufacturing sites, unobserved risk parameters,
a plurality of previous compliance inspection results at the
pharmaceutical product manufacturing site including
observed inspection data, and observed data for the
corresponding management entity
(step (a)); (2) “estimating a plurality of hyper-parameters based on the data,
the hyper-parameters determining assumed prior probabilistic relationships
among the unobserved risk parameters” (step (b)); (3) for each of the
pharmaceutical product manufacturing sites, determining a risk score that
corresponds to expected deficiencies that would be found if the
pharmaceutical product manufacturing site was inspected, i.e.,
for each of the pharmaceutical product manufacturing
sites, determining a risk score that corresponds to expected
deficiencies that would be found if the pharmaceutical product
manufacturing site was inspected, wherein a poor risk score
corresponds to a higher risk of having deficiencies, and at least
one previous deficiency identified by the plurality of previous
compliance inspection results at the pharmaceutical product
manufacturing site worsens the determined risk score for the
pharmaceutical product manufacturing site based, at least in part,
upon an amount of time that has elapsed since the previous
deficiency was identified
(step (c)); and (4) scheduling compliance inspections of the pharmaceutical
product manufacturing sites based on the determined risk score such that
manufacturing sites that have a higher estimated level of risk are scheduled
before sites that have a lower estimated level of risk, the risk score being
based on a statistical model, including a logistic regression relationship, i.e.,
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scheduling the compliance inspections of the
pharmaceutical product manufacturing sites by the
pharmacovigilance team based on the determined risk score,
wherein pharmaceutical product manufacturing sites that have a
higher estimated level of risk are scheduled before
pharmaceutical product manufacturing sites that have a lower
estimated level of risk,
wherein the risk score is based on a statistical model
comprising a relationship between the unobserved risk
parameters for the pharmaceutical product manufacturing
site, the observed inspection data for the pharmaceutical
product manufacturing site, and the observed data for the
corresponding management entity of the pharmaceutical
product manufacturing site, the risk score having a
binomial distribution with a mean exp(θisq), and
wherein the statistical model includes a logistic
regression relationship between observed events and risk
parameters that is given by:
P(Yisqk=1) = 1 /[1 + exp(ak – bk θisq)],
where P() indicates a probability function,
where Yisqk indicates a presence or absence of a particular
event k at a particular time period q relating to a particular
management entity i and pharmaceutical product manufacturing
site s,
where θisq are the unobserved risk parameters for
pharmaceutical product manufacturing site i,
where i=1, . . ., C; where C is a total number of
management entities,
where s=1, . . ., Si; where Si is a total number of
pharmaceutical product manufacturing sites for management
entity i,
where q=1, . . ., Q; where Q is a total number of time
periods,
where k=1, . . ., K; where K is a total number of events,
and
where ak and bk are estimated logistic coefficients for
event k
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(step (d)). These limitations, when given their broadest reasonable
interpretation, recite scheduling compliance inspections of pharmaceutical
product manufacturing sites based on a risk score, calculated using a
statistical model. Although claim 1 recites that the method steps are
executed by a processor, the underlying processes recited in the claim are all
acts that could be performed by a human, e.g., mentally or manually, using
pen and paper, without the use of a computer or any other machine. For
example, a person could receive, via oral or written communication, data
relating to a plurality of pharmaceutical product manufacturing sites. Such a
person, using pen and paper, also could calculate a risk score, for each of the
plurality of manufacturing sites, and could schedule compliance inspections
of the manufacturing sites based on the calculated risk scores, via either
written or oral communication. Simply put, claim 1 recites a mental process,
i.e., a concept performed in the human mind, including an evaluation or
judgment, and therefore, an abstract idea. See 2019 Revised Guidance,
84 Fed. Reg. at 52; CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d
1366, 1373 (Fed. Cir. 2011) (holding that method steps that can be
performed in the human mind, or by a human using a pen and paper, are
unpatentable mental processes). See also Elec. Power Grp., LLC v. Alstom,
S.A., 830 F.3d 1350, 1355 (Fed. Cir. 2016) (explaining that the Federal
Circuit treats “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”); 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
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underlying, patent-ineligible invention could be performed via pen and paper
or in a person’s mind.”).
Having concluded that claim 1 recites a judicial exception, i.e., an
abstract idea (Step 2A, Prong One), we next consider whether the claim
recites additional elements that integrate the judicial exception into a
practical application (Step 2A, Prong Two).
The only additional elements recited in claim 1, beyond the abstract
idea, are a computer readable medium having instructions stored thereon and
a processor that executes the stored instructions — elements recited at a high
level of generality, and described in the Specification as generic computer
components (see, e.g., Spec. ¶¶ 24, 25, 45). We find no indication in the
Specification, nor does Appellant direct us to any indication, that the
operations recited in claim 1 invoke any assertedly inventive programming,
require any specialized computer hardware or other inventive computer
components, i.e., a particular machine, or that the claimed invention is
implemented using other than generic computer components to perform
generic computer functions. See DDR Holdings, LLC v. 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.”).
We also find no indication in the Specification that the claimed
invention effects a transformation or reduction of a particular article to a
different state or thing. Nor do we find anything of record that attributes an
improvement in technology and/or a technical field to the claimed invention
or that otherwise indicates that the claimed invention integrates the abstract
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idea into a “practical application,” as that phrase is used in the 2019 Revised
Guidance.6
Appellant asserts that “the recitations of claim 1 plainly include a
computer generated statistical model that leverages a probability function to
predict risk at various manufacturing sites” (Appeal Br. 8). And Appellant
ostensibly maintains that claim 1 is not directed to an abstract idea because
“the machine performed risk prediction from claim 1 is achieved with steps
that are more complicated than a human would perform” (id. at 11).
Appellant argues that “a human would not generate . . . a statistical model
that includes a regression relationship between observed events and risk
parameters when predicting a risk at these manufacturing sites, as this
technique is the way machines perform predictions, not humans” (id.). Yet,
aside from the recitation that the method steps are executed by a processor,
we find nothing in the claim language that forecloses the claimed steps from
being performed by a human, mentally or with pen and paper. In this regard,
we agree with the Examiner that “though less efficient, one of ordinary skill
in the art could reduce the recited mathematical operations comprising
exponential multiplication, division, and subtraction to pen and paper by
employing human cognition. That is to say, a human can calculate a logistic
regression like a computer, albeit less efficiently” (Final Act. 16–17).

6 The 2019 Revised Guidance references MPEP § 2106.05(a)–(c) and (e) in
listing considerations that are indicative that an additional element or
combination of elements integrates the judicial exception, e.g., the abstract
idea, into a practical application. 2019 Revised Guidance, 84 Fed. Reg.
at 55. If the recited judicial exception is integrated into a practical
application, as determined under one or more of these MPEP sections, the
claim is not “directed to” the judicial exception.
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That a computer may be required is, moreover, an insufficient basis to
persuasively argue that claim 1 is not directed to an abstract idea. Indeed, a
substantially similar argument was expressly rejected by the Court in Alice.
Thus, although the claimed invention in Alice involved a computer system
acting as a third-party intermediary between two parties — “As stipulated,
the claimed method requires the use of a computer to create electronic
records, track multiple transactions, and issue simultaneous instructions; in
other words, ‘[t]he computer is itself the intermediary,’” Alice Corp.,
573 U.S. at 224 — the Court held that “the claims at issue amount to
‘nothing significantly more’ than an instruction to apply the abstract idea of
intermediated settlement using some unspecified, generic computer.” Id.
at 225–26. See also FairWarning IP, LLC v. Iatric Systems, Inc., 839 F.3d
1089, 1098 (Fed. Cir. 2016) (“the inability for the human mind to perform
each claim step does not alone confer patentability. As we have explained,
‘the fact that the required calculations could be performed more efficiently
via a computer does not materially alter the patent eligibility of the claimed
subject matter.’”) (citation omitted); In re TLI Commc’ns LLC Patent Litig.,
823 F.3d 607, 611 (Fed. Cir. 2016) (“[N]ot every claim that recites concrete,
tangible components escapes the reach of the abstract-idea inquiry.”).
Similarly here, the computer implementation is purely generic and
performs generic computer functions, i.e., receiving and processing
information. As described above, there is no indication in the Specification
that any inventive computer components or specialized computer hardware
is required. Instead, it is clear from the Specification that the claimed
invention is implemented using generic computer components (see, e.g.,
Spec. ¶ 24), which the Court made clear in Alice is insufficient to transform
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an otherwise patent-ineligible abstract idea into patent-eligible subject
matter. Alice Corp., 573 U.S. at 223 (holding that if a patent’s recitation of a
computer amounts to a mere instruction to implement an abstract idea on a
computer, that addition cannot impart patent eligibility).
We also do not agree with Appellant that there is any parallel between
claim 1 and the claims at issue in McRO, Inc. v. Bandai Namco Games
America, Inc., 837 F.3d 1299, 1312 (Fed. Cir. 2016) (Appeal Br. 12–14; see
also Reply Br. 8–10). Claim 1 of the ’576 patent,7 at issue in McRO, is
directed to a method for automatically animating the lip synchronization and
facial expressions of three-dimensional animated characters, and recites that
the method comprises, inter alia, “obtaining a first set of rules that define
output morph weight set stream as a function of phoneme sequence and time
of said phoneme sequence.” McRO, 837 F.3d at 1307–08. The Federal
Circuit determined that the claim, when considered as a whole, is directed to
a technological improvement over existing, manual 3–D animation
techniques, and uses limited rules in a process specifically designed to
achieve an improved technological result relative to conventional industry
practice. Id. at 1316. As such, the court determined that the claim is not
directed to an abstract idea, and is patent eligible under 35 U.S.C. § 101. Id.
Appellant argues here that the pending claims are not directed to an
abstract idea because, similar to the claim in McRO, the claims are directed
to an improvement in the “space of machine prediction” (Appeal Br. 13).
Appellant, thus, maintains that, similar to McRO, “the present claims recite
the use of specific rules to improve the manner in which a computer

7 U.S. Patent No. 6,307,576, issued October 23, 2001.
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performs machine prediction” (id.). And Appellant cites the use of “a
constructed statistical model, a specific [probability] function, and specific
inputs” as providing improvements in the space of machine prediction (id.;
see also Reply Br. 10 (“[T]he determined risk score and statistical model
recited in the claims achieves inspection of pharmaceutical product
manufacturing sites in a manner that is wholly different from convention.”).
The difficulty with Appellant’s argument is that it, at best, merely
establishes that the statistical model, including the recited probability
function, is a new and improved mathematical formula/algorithm, i.e., an
improved abstract idea, for determining a risk score that corresponds to
expected deficiencies that would be found if a particular pharmaceutical
product manufacturing site was inspected. As the court observed in SAP
America, Inc. v. InvestPic, LLC, 898 F.3d 1161 (Fed. Cir. 2018), the claims
in McRO were directed to “the creation of something physical — namely,
the display of ‘lip synchronization and facial expressions’ of animated
characters on screens for viewing by human eyes” and “[t]he claimed
improvement was to how the physical display operated (to produce better
quality images).” Id. at 1167. Here, like the claims at issue in SAP America
(which the court determined were directed to abstract ideas, i.e., selecting
certain information, analyzing it using mathematical techniques, and
reporting or displaying the results of the analysis), the claimed improvement
is a “mathematical technique with no improved display mechanism.” Id.
However valuable or useful the statistical model may be in predicting
manufacturing site deficiencies, its value or usefulness is not dispositive of
patent eligibility. See Parker v. Flook, 437 U.S. 584, 594–95 (1978)
(holding claims to “a new and presumably better method for calculating
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alarm limit values,” of undisputed usefulness, to be directed to patent-
ineligible subject matter); see also Ass’n for Molecular Pathology v. Myriad
Genetics, Inc., 569 U.S. 576, 591 (2013) (“Groundbreaking, innovative, or
even brilliant discovery does not by itself satisfy the § 101 inquiry.”). An
improved abstract idea is still an abstract idea. Cf. Mayo, 566 U.S. at 90
(holding that a novel and nonobvious claim directed to a purely abstract idea
is, nonetheless, patent ineligible).
It also is not controlling that claim 1 presents no risk of preemption
(Appeal Br. 15; see also id. at 17). Although the Supreme Court has
described “the concern that drives [the exclusion of abstract ideas from
patent-eligible subject matter] as one of pre-emption,” Alice Corp., 573 U.S.
at 216, characterizing preemption as a driving concern for patent eligibility
is not the same as characterizing preemption as the sole test for patent
eligibility. “The Supreme Court has made clear that the principle of
preemption is the basis for the judicial exceptions to patentability” and “[f]or
this reason, questions on preemption are inherent in and resolved by the
§ 101 analysis.” Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371,
1379 (Fed. Cir. 2015) (citing Alice Corp., 573 U.S. at 216). “[P]reemption
may signal patent ineligible subject matter, [but] the absence of complete
preemption does not demonstrate patent eligibility.” Id.
Addressing the 2019 Revised Guidance, Appellant argues in the Reply
Brief, that even if “abstract ideas were included in claim 1,” the claim
“recites a practical application of the statistical model recited in the claim”
(Reply Br. 2–3). We disagree.
As described above, the 2019 Revised Guidance lists various
considerations that are indicative that an additional element or combination
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of elements integrates a judicial exception, e.g., an abstract idea, into a
practical application. For example, a practical application may be reflected
in an improvement in the functioning of a computer or an improvement to
other technology or technical field, a particular machine or manufacture
integral to the claim, or a transformation or reduction of an article to a
different state or thing. See 2019 Revised Guidance, 84 Fed. Reg. at 55.
However, merely using a computer as a tool to perform an abstract idea,
adding insignificant extra-solution activity, or only generally linking the use
of a judicial exception to a particular technological environment or field are
not sufficient to integrate the judicial exception into a practical application.
See id.
Appellant asserts here that “the functionality of the additional
elements of ‘scheduling the compliance inspections of the pharmaceutical
product manufacturing sites by the pharmacovigilance team based on the
determined risk score’” such that product manufacturing sites that have a
higher estimated level of risk are scheduled before pharmaceutical product
manufacturing sites that have a lower estimated level of risk, as recited in
claim 1, “integrates the claimed risk score and statistical model into a
practical application” that “improves upon the inspection of pharmaceutical
product manufacturing sites by integrating sophisticated modeling and
machine prediction techniques into the inspections” (Reply Br. 3–4). And
Appellant argues that “[t]his specific integration imposes meaningful limits
on the risk score and/or statistical model, such that the claim is more than a
drafting effort designed to monopolize the risk score/statistical model” (id.
at 4). Yet, without the risk score and statistical model, claim 1 would be
reduced, per Appellant’s characterization of the “additional elements,” to
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mere data gathering — “receiving data relating to a plurality of
pharmaceutical product manufacturing sites” — in other words, to
“insignificant extra-solution activity” (see Ans. 4)8 and merely linking the
use of the judicial exception, i.e., the statistical model, to a particular field of
use, i.e., scheduling inspections of pharmaceutical product manufacturing
sites9 — considerations indicative that an additional element or combination
of elements does not integrate the judicial exception into a practical
application.
Appellant cites Examples 40 and 42 of the USPTO’s “Subject Matter
Eligibility Examples: Abstract Ideas” issued January 7, 2019 (the “2019
Examples”) 10 as supporting its position (Reply Br. 4–7). Yet, rather than
paralleling hypothetical claims 1 in Examples 40 and 42, pending claim 1, in
our view, is akin to hypothetical claims 2 of these examples, which the
USPTO concluded were patent ineligible. Here, as in hypothetical claims 2,

8 See 2019 Revised Guidance, 84 Fed. Reg. at 55 n.31; see also 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); Bancorp Servs,
L.L.C. v. Sun Life Assur. Co. of Can., 771 F. Supp. 2d 1054, 1066 (E.D. Mo.
2011) aff'd, 687 F.3d 1266 (Fed. Cir. 2012) (explaining that “storing,
retrieving, and providing data . . . are inconsequential data gathering and
insignificant post solution activity”).
9 Although we consider the steps of “receiving data relating to a plurality of
pharmaceutical product manufacturing sites” and “scheduling the
compliance inspections of the pharmaceutical product manufacturing sites
by the pharmacovigilance team based on the determined risk score” as part
of the abstract idea itself, for the limited purpose of addressing Appellant’s
argument, we alternatively treat these steps as “additional elements.”
10 Available at https://www.uspto.gov/sites/default/files/documents/
101_examples_37to42_20190107.pdf.
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the additional elements, as identified by Appellant, amount to mere data
gathering, i.e., insignificant extra-solution activity, or are no more than mere
instructions to apply the judicial exception using a generic computer
component. See 2019 Examples 11–13, 19–20. As such these additional
elements do not integrate the judicial exception into a practical application.
Id.
We also are not persuaded of Examiner error to the extent Appellant
maintains that claim 1 is not directed to an abstract idea and is analogous to
the claims that the Court upheld as patent eligible in Diamond v. Diehr,
450 U.S. 175 (1981) (Reply Br. 7–8). The claims in Diehr were directed to
a process for curing synthetic rubber, and recited a series of steps (e.g., the
loading of a molding press with raw, uncured rubber, closing the press,
constantly determining the mold temperature, constantly recalculating the
cure time, and automatically opening the press at the proper time) that
together provided a significant and novel practical application of the well-
known Arrhenius equation and transformed uncured synthetic rubber into a
new state or thing. See Diehr, 450 U.S. at 184–87. In holding the claims
patent eligible, the Court explained:
[W]e think that a physical and chemical process for molding
precision synthetic rubber products falls within the § 101
categories of possibly patentable subject matter. That
respondents’ claims involve the transformation of an article, in
this case raw, uncured synthetic rubber, into a different state or
thing cannot be disputed. The respondents’ claims describe in
detail a step-by-step method for accomplishing such, beginning
with the loading of a mold with raw, uncured rubber and ending
with the eventual opening of the press at the conclusion of the
cure. Industrial processes such as this are the types which have
historically been eligible to receive the protection of our patent
laws.
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Id. at 184. Appellant asserts here that just as “the inclusion of the
mathematical formula did not render [the] claim at issue in Diehr directed
towards an abstract idea, as the mathematical formula was part of a larger
process,” claim 1 “implements the statistical model within a practical
application, namely the scheduling of inspections of pharmaceutical product
manufacturing sites by the pharmacovigilance team based on the determined
risk score/statistical model” (Reply Br. 8). We, however, fail to see how
scheduling inspections of pharmaceutical product manufacturing sites is
similar to controlling a physical process like the process in Diehr. Claim 1
does not involve any “industrial” or “physical and chemical process” and
does not involve the “transformation of an article . . . into a different state or
thing.”
We conclude, for the reasons outlined above, that claim 1 recites a
mental process, i.e., an abstract idea, and that the additional elements recited
in the claim are no more than generic computer components used as tools to
perform the recited abstract idea. As such, they do not integrate the abstract
idea into a practical application. See Alice Corp., 573 U.S. at 223–24
(“[W]holly generic computer implementation is not generally the sort of
‘additional featur[e]’ that provides any ‘practical assurance that the process
is more than a drafting effort designed to monopolize the [abstract idea]
itself.’” (quoting Mayo, 566 U.S. at 77)). Accordingly, we agree with the
Examiner that claim 1 is directed to an abstract idea.
Step Two of the Mayo/Alice Framework (2019 Revised Guidance, Step 2B)
Having determined under step one of the Mayo/Alice framework that
claim 1 is directed to an abstract idea, we next consider under Step 2B of the
2019 Revised Guidance, the second step of the Mayo/Alice framework,
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whether claim 1 includes additional elements or a combination of elements
that provides an “inventive concept,” i.e., whether the additional elements
amount to “significantly more” than the judicial exception itself.
2019 Revised Guidance, 84 Fed. Reg. at 56.
Appellant argues that even if claim 1 is directed to an abstract idea,
the claim is nonetheless patent eligible because “the ordered combination
recited in the claim renders the claim significantly more than any abstract
idea” (Appeal Br. 18). Appellant attempts to draw an analogy between
claim 1 and the claims at issue in BASCOM Global Internet Services, Inc. v.
AT&T Mobility LLC, 827 F.3d 1341 (Fed. Cir. 2016) (id. at 18–19). But, we
find no parallel between claim 1 and the claims at issue in BASCOM.
In BASCOM, the Federal Circuit determined that the claimed
installation of a filtering tool at a specific location, remote from the end-
users, with customizable filtering features specific to each end user provided
an inventive concept in that it gave the filtering tool both the benefits of a
filter on a local computer and the benefits of a filter on the ISP server.
BASCOM, 827 F.3d at 1350. And the court held that the second step of the
Mayo/Alice framework was satisfied because the claimed invention
“represents a ‘software-based invention[ ] that improve[s] the performance
of the computer system itself.’” Id. at 1351 (stating that like DDR Holdings,
where the patent “claimed a technical solution to a problem unique to the
Internet,” the patent in BASCOM claimed a “technology-based solution . . .
to filter content on the Internet that overcomes existing problems with other
Internet filtering systems . . . making it more dynamic and efficient”)
(internal citations omitted).
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Appellant asserts here that claim 1 recites “specific improvements to
computer technology” (Appeal Br. 19). Yet, Appellant does not identify,
and we do not find, any improvement to computer technology analogous to
the ordered combination described in BASCOM or any additional element or
elements recited in claim 1 that yield an improvement in the functioning of a
computer.
Appellant paraphrases the language of claim 1 (id. at 18–19). And
Appellant argues that “this ordered combination of elements improves the
manner in which machine prediction of risk is performed” and, “similar to
the claims in Bascom, . . . recites significantly more than any alleged abstract
idea” (id. at 19). Yet, the limitations to which Appellant refers, including
“estimating a plurality of hyper-parameters” and “determining a risk
score . . . based on a statistical model,” are part of the abstract idea itself;
they are not additional elements to be considered when determining whether
claim 1 includes additional elements or a combination of elements that is
sufficient to amount to significantly more than the judicial exception.
It could not be clearer from Alice, that under step two of the
Mayo/Alice framework, the elements of each claim are considered both
individually and “as an ordered combination” to determine whether the
additional elements, i.e., the elements other than the abstract idea itself,
“transform the nature of the claim” into a patent-eligible application.
Alice Corp., 573 U.S. at 217 (internal quotations and citation omitted);
see Mayo, 566 U.S. at 72–73 (requiring that “a process that focuses upon the
use of a natural law also contain other elements or a combination of
elements, sometimes referred to as an ‘inventive concept,’ sufficient to
ensure that the patent in practice amounts to significantly more than a patent
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upon the natural law itself”) (emphasis added). In other words, the inventive
concept under step two of the Mayo/Alice framework cannot be the abstract
idea itself:
It is clear from Mayo that the “inventive concept” cannot be the
abstract idea itself, and Berkheimer . . . leave[s] untouched the
numerous cases from this court which have held claims ineligible
because the only alleged “inventive concept” is the abstract idea.
Berkheimer v. HP, Inc., 890 F.3d 1369, 1374 (Fed. Cir. 2018) (Moore, J.,
concurring); see also BSG Tech, 899 F.3d at 1290 (“It has been clear since
Alice that a claimed invention’s use of the ineligible concept to which it is
directed cannot supply the inventive concept that renders the invention
‘significantly more’ than that ineligible concept.”) (internal citation
omitted).
The only claim elements recited in claim 1 beyond the abstract idea
are the computer readable medium having instructions stored thereon, and
the processor that executes the stored instructions, i.e., generic computer
components used to perform generic computer functions — a determination
amply supported by, and fully consistent with, the Specification (see, e.g.,
Spec. ¶ 24).11 Appellant cannot reasonably contend, nor does Appellant,
that the operation of these components is not well-understood, routine, or

11 The Office’s April 19, 2018 Memorandum to the Examining Corps from
Deputy Commissioner for Patent Examination Policy, Robert W. Bahr,
entitled, Changes in Examination Procedure Pertaining to Subject Matter
Eligibility, Recent Subject Matter Eligibility Decision (Berkheimer v. HP,
Inc.), available at https://www.uspto.gov/sites/default/files/documents/
memo-berkheimer-20180419.PDF, expressly directs that an examiner may
support the position that an additional element (or combination of elements)
is well-understood, routine or conventional with “[a] citation to an express
statement in the specification . . . that demonstrates the well-understood,
routine, conventional nature of the additional element(s)” (id. at 3).
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conventional, where, as here, there is nothing in the Specification to indicate
that the operations recited in claim 1 require any specialized hardware or
inventive computer components, invoke any assertedly inventive software,
or that the claimed invention is implemented using other than generic
computer components to perform generic computer functions, e.g.,
receiving, transmitting, and processing information.12
We are not persuaded, on the present record, that the Examiner erred
in rejecting independent claim 1 under 35 U.S.C. § 101. Therefore, we
sustain the Examiner’s rejection of claim 1, and dependent claims 4, 19,
and 21, which are not argued separately except based on their dependence
from claim 1 (Appeal Br. 22–23).
Independent Claims 7 and 13 and Dependent Claims 10, 16, 20, and 22–24
Appellant argues that independent claims 7 and 13 are patent eligible
for reasons similar to those set forth with respect to claim 1 (id.). We are not
persuaded for the reasons set forth above that the Examiner erred in rejecting
claim 1 under 35 U.S.C. § 101. Therefore, we sustain the Examiner’s
rejection of claims 7 and 13 for the same reasons. We also sustain the

12 Appellant argues that “per Berkheimer, the additional elements for which
evidence must be provided include the functional elements beyond the mere
hardware components” (Reply Br. 12). It is not entirely clear to what
“functional elements” Appellant refers. However, to the extent, Appellant
maintains that evidence is required to establish the well-understood, routine,
conventional nature of “receiving data relating to a plurality of
pharmaceutical product manufacturing sites” and “scheduling the
compliance inspections,” we note that receiving data is a routine and
conventional activity which virtually any generic computing device can
perform and that the well-understood, routine, and conventional nature of
scheduling compliance inspections is evident from Appellant’s own
Specification (see, e.g., Spec. ¶¶ 2-4).
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rejection of dependent claims 10, 16, 20, and 22–24, which are not argued
separately except based on their dependence from claims 7 and 13 (id.).
CONCLUSION
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)
/Basis
Affirmed Reversed
1, 4, 6, 7, 10,
12, 13, 16,
18–24
101 Eligibility 1, 4, 6, 7, 10,
12, 13, 16,
18–24

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