Dimitri Betses et al.

Patent Trials and Appeals Board

Mar 16, 2021

2020004497 (P.T.A.B. Mar. 16, 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.
13/090,946 04/20/2011 Dimitri G. Betses 10309-06613 US 3571
145838 7590 03/16/2021
Patent Law Works LLP/CVS Pharmacy, Inc.
310 East 4500 South, Suite 400
Salt Lake City, UT 84107
EXAMINER
PORTER, RACHEL L
ART UNIT PAPER NUMBER
3626
NOTIFICATION DATE DELIVERY MODE
03/16/2021 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):
docketing@patentlawworks.net
patents@patentlawworks.net
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________

Ex parte DIMITRI G. BETSES, SIDHARTH S. SAHNI,
CHRISTOPHER L. COX, and TIMOTHY A. DUCHARME
____________________

Appeal 2020-004497
Application 13/090,946
Technology Center 3600
____________________

Before ALLEN R. MacDONALD, CAROLYN D. THOMAS, and
DAVID J. CUTITTA II, Administrative Patent Judges.

MacDONALD, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1–7, 10–17, 19, and 20. Appeal Br. 5.
Claims 8, 9, and 18 have been cancelled. Id. We have jurisdiction under
35 U.S.C. § 6(b). We affirm.

1 Appellant refers to “applicant” as defined in 37 C.F.R. § 1.42(a).
Appellant identifies real party in interest in the present appeal is CVS
Pharmacy, Inc. Appeal Br. 3.
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CLAIMED SUBJECT MATTER
Claim 1 is illustrative of the claimed subject matter (emphasis and
bracketed material added):
1. A method for managing medication adherence of a patient,
comprising the steps of:
[A.] receiving patient information comprising patient
name, telephone number, and prescription
information;
[B.] storing the patient information in one or more
databases;
[C.] identifying a patient type;
[D.] identifying a medication type associated with a
medication therapy;
[E.] identifying a probability that the patient will not
adhere to the medication therapy based on a
combination of the patient type and the medication
type using a database including probabilities of non-
adherence for combinations of patient types and
medication types; and
[F.] in response to the probability that the patient will not
adhere to the medication therapy:
[i.] identifying a first time after the patient receives
the filled prescription to call the patient based
on an initial efficacy of the medication
therapy;
[ii.] placing a first telephone call to the patient at the
first time;
[iii.] placing a second telephone call to the patient,
using an interactive voice response system,
prior to the day that the prescription is refilled;
and
[iv.] placing a third telephone call to the patient in
the event the prescription is past due for a refill.
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REFERENCES2
The Examiner relies on the following reference:
Name Reference Date
Akers US 6,112,182 Aug. 29, 2000
Denenberg US 6,464,142 B1 Oct. 15, 2002
Miller US 2008/0126130 A1 May 29, 2008
Hanina US 2011/0153361 A1 June 23, 2011

REJECTIONS
A.
The Examiner rejects claims 1–7, 10–17, 19, and 20 under 35 U.S.C.
§ 101 “because the claimed invention is directed to a judicial exception (i.e.,
a law of nature, a natural phenomenon, or an abstract idea) without
significantly more” (Final Act. 2), i.e., the claimed invention is directed to
patent-ineligible subject matter. Final Act. 2–10.
We select claim 1 as representative. See 37 C.F.R. § 41.37(c)(1)(iv).
Appellant does not separately argue claims 2–7, 10–17, 19, and 20. Except
for our ultimate decision, we do not discuss the merits of the § 101 rejection
of claims 2–7, 10–17, 19, and 20 further herein.
B.
The Examiner rejects claims 1–7, 10–17, 19, and 20 under 35 U.S.C.
§ 103(a) as being as being unpatentable over the combination of Akers,
Denenberg, Hanina, and Miller. Final Act. 10–26.

2 All citations herein to patent and pre-grant publication references are by
reference to the first named inventor only.
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We select claim 1 as the representative claim for this rejection. The
contentions discussed herein as to claim 1 are dispositive as to this rejection.
Therefore, except for our ultimate decision, we do not address the merits of
the § 103(a) rejection of claims 2–7, 10–17, 19, and 20 further herein.

OPINION
We have reviewed the Examiner’s rejections in light of Appellant’s
arguments that the Examiner has erred. We concur with the Examiner’s
ultimate conclusion that claims 1–7, 10–17, 19, and 20 are not patentable.
We highlight the following points.
A. 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. 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 waterproof 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; see also id. at 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. (citing Benson and
Flook); see, e.g., id. at 187 (“It is now commonplace that an application of a
law of nature or mathematical formula to a known structure or process may
well be deserving of patent protection.”).
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If the claim is “directed to” an abstract idea, we turn to the second part
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.
B. USPTO § 101 Guidance
In January 2019, the U.S. Patent and Trademark Office (USPTO)
published revised guidance on the application of § 101.3 The Manual of
Patent Examining Procedure (“MPEP”) now incorporates this revised
guidance and subsequent updates at § 2106 (9th ed. Rev. 10.2019, rev. June
2020).4

3 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50
(Jan. 7, 2019) (“2019 Revised Guidance”). In response to received public
comments, the Office issued further guidance on October 17, 2019,
clarifying the 2019 Revised Guidance. USPTO, October 2019 Update:
Subject Matter Eligibility (the “October 2019 Update”). “All USPTO
personnel are, as a matter of internal agency management, expected to
follow the guidance.” 84 Fed. Reg. at 51; see also October 2019 Update
at 1.
4 All references to the MPEP are to the Ninth Edition, Revision 10.2019
(Last Revised June 2020), unless otherwise indicated.
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Under MPEP § 2106, we first look to whether the claim recites:
(1) any judicial exceptions, including certain groupings of abstract
ideas (i.e., mathematical concepts, certain methods of organizing
human activity such as a fundamental economic practice, or mental
processes) (“Step 2A, Prong One”); and
(2) additional elements that integrate the judicial exception into a
practical application (“Step 2A, Prong Two”).5
MPEP § 2106.04(a) and § 2106.04(d).
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 claim:
(3) adds a specific limitation beyond the judicial exception that is not
“well-understood, routine, conventional activity” in the field; or
(4) simply appends well-understood, routine, conventional activities
previously known to the industry, specified at a high level of
generality, to the judicial exception.
MPEP § 2106.05(d).
C. Examiner’s § 101 Rejection - Alice/Mayo - Parts 1 and 2
C.1. 2019 Revised Guidance Step 2A – Prong One
Applying the Alice/Mayo framework, the Examiner determines that
claim 1 recites an abstract idea of “organizing human activity.” Final Act. 4.

5 “Examiners evaluate integration into a practical application by:
(1) identifying whether there are any additional elements recited in the claim
beyond the judicial exception(s); and (2) evaluating those additional
elements individually and in combination to determine whether they
integrate the exception into a practical application.” MPEP § 2106.04(d)II.
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In particular, claim(s) 1–7 and 10–12 recite:
[C.] identifying a patient type;
[D.] identifying a medication type associated with the
medication therapy;
[E.] identifying a probability that the patient will not
adhere to a medication therapy based on a combination of the
patient type and the medication type using a database including
probabilities of non-adherence for combinations of patient types
and medication types; and
[F.i.] identifying a first time alter the patient receives the
filled prescription to call the patient based on an initial efficacy
of the medication therapy;
[F.ii.] placing a first telephone call to the patient after the
patient receives the filled prescription at the first time;
[F.iii.] placing a second telephone call to the patient, using
an interactive voice response system, prior to the day that the
prescription is due for a refill; and
[F.iv.] placing a third telephone call to the patient in the
event the prescription is past due for a refill.
Final Act. 5 (bracketed material added).
C.2. 2019 Revised Guidance Step 2A – Prong Two
Further applying the Alice/Mayo framework, the Examiner determines
claim 1 is directed to an abstract idea.
This judicial exception[] recited in the claims [is] not
integrated into a practical application because the claim language
does not recite any improvements to the functioning of a
computer, or to any other technology or technical field (see
MPEP 2106.05(a)); applying the judicial exception with, or by
use of, a particular machine (see MPEP 2106.05(b)); effecting a
transformation or reduction of a particular article to a different
state or thing (see MPEP 2106.05(c)); or applying or using the
judicial exception in some other meaningful way beyond
generally linking the use of the judicial exception to a particular
technological environment see MPEP 2106.05(e).
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Final Act. 6.
The claim(s) does/do not include additional elements that are
sufficient to amount to significantly more than the judicial
exception because the additional steps amount to insignificant
extra-solution activity to the judicial exception (see MPEP
2106.05(g)).
Final Act. 8 (emphasis added).
C.3. 2019 Revised Guidance Step 2B
Applying the Alice/Mayo framework, the Examiner determines:
Exemplary claims 1 and 13 recite additional limitation(s),
including an “interactive voice response system” (i.e. IVR) and
a database. These components []are generic functions well-
understood, routine and conventional components.
To support the finding of the identified features being
generic and conventional, the generic nature of the interactive
voice response system is underscored by the applicant’s
disclosure which states:
“The IVR system is an automated telephone system
that provides information to the patient by making
a telephone call to the patient, providing a pre-
recorded message, prompting the patient for
information, presenting the patient with a set of
options, and recording information provided by the
patient. In one example, the IVR system is
implemented by a Microsoft SQL Server database
operating Microsoft Windows software in
conjunction with a switch from Sonus Networks to
initiate the telephone call to the patient, Voice XML
for scripting, and software from Nuance
Communications, Inc. . . .”
([Spec.] pg. 9, par 31)[.]
Furthermore, the applicant’s specification describes the
system database as part of the generic computer system:
“The database 100 for storing the patient
information may be located at the pharmacy or in a
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remote location. The database 100 may comprise a
central processing unit (CPU) 102, random access
memory (RAM) 104, read-only memory (ROM)
106, one or more mass data storage elements 108.”
([Spec.] pg. 5, par 19)[.]
Claims 1 and 13 also recite receiving patient information
comprising patient name, telephone number, and prescription
information; storing the patient information in one or more
databases, which are functions that are well-understood, routine
and conventional activities previously known in the pertinent
industry.
The courts have recognized the certain computer functions
as well-understood, routine and conventional functions when
they are claimed in a merely generic manner (e.g., at a high level
of generality) or as insignificant extra-solution activity (See
MPEP 2106.05 (d) (II)). Among these are the following features,
which are recited in claims 1 and 13:
 Receiving or transmitting data over a network,
e.g., using the Internet to gather data, [citations
omitted].
 Storing and retrieving information in memory
[citations omitted].
Final Act. 8–10 (emphasis and formatting added; original italics omitted).
D. Appellant’s § 101 Arguments & Panel’s Analysis
D.1. 2019 Revised Guidance Step 2A, Prong 1
The Examiner determines that claim 1 recites an abstract idea of
“organizing human activity.” Final Act. 4. As noted supra, in particular, the
Examiner determines that steps C–F.iv. recite a method directed to the idea
of improved patient outreach for managing medication adherence of the
patient.
Appellant does not dispute the Examiner’s determination. In short,
the Examiner correctly determines that claim 1 recites a method directed to
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the improved patient outreach for managing medication adherence of the
patient (i.e., managing personal behavior (including following rules or
instructions)); and managing personal behavior is one of certain methods of
organizing human activity identified in the 2019 Revised Guidance, and thus
an abstract idea. MPEP § 2106.04(a).
D.2. 2019 Revised Guidance Step 2A, Prong 2
Having determined that claim 1 recites an abstract idea, we now turn
to whether claim 1 is directed to that abstract idea, or instead integrates the
judicial exception into a practical application.
D.2.a.
The Examiner determines:
This judicial exception[] recited in the claims [is] not
integrated into a practical application because the claim language
does not recite any improvements to the functioning of a
computer, or to any other technology or technical field (see
MPEP 2106.05(a)).
Final Act. 6.
D.2.b.i.
In the Appeal Brief, Appellant contends:
As an initial matter, the Examiner has suggested that
“managing medication adherence of a patient” is an inventive
concept directed to an abstract idea. [l/14/19 Office Action, p.2].
However, Appellant’s claims and supporting specification are
not merely directed to managing medication adherence in the
abstract, but a very real technical challenge in automated
systems for scheduling customer outreach, such as pharmacy
computer systems. The claimed invention uses “a combination
of technology and in-person or over-the-phone interactions to
provide a series of coordinated patient interventions during a
patient’s continuum of care.” [Spec., para. 0014]. The technical
elements are implemented through pharmacy computer systems
supported by enterprise database systems [Spec., para. 0019-
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0020] and represent improvements to the functioning of those
computers and technical fields.
Appeal Br. 12 (emphasis added).
In the present case, the claim elements from claim 1, for
example:
[claim 1, steps E, F.i., and F.ii. omitted]
both contain additional elements and use any purportedly
abstract ideas they contain in a practical application. This
detailed process reflects an improvement in the functioning of
pharmacy computer systems governing patient outreach.
Further, the combination of identifying a probability that the
patient will not adhere (using a pharmacy database) and
identifying a time to call the patient based on initial efficacy
corrects a problem (e.g. non-compliance) in prior patient
outreach systems in a meaningful way beyond generally
linking the use to a particular technological environment.
These detailed claims in no way monopolize any abstract idea.
In addition, other elements of the claims, for example:
[claim 1, steps A, B, F.iii., and F.iv. omitted]
are not “merely applying” abstract ideas, but provide a detailed
technical context within the computing environment for
pharmacy computer systems and related workflow. As a whole,
claim 1 describes a practical application of a technology for
improving patient compliance through a practical process using
pharmacy computer systems.
Appeal Br. 13–14 (emphasis added).
D.2.b.ii.
In the Reply Brief, Appellant newly contends:
Example 37 in the Subject Matter Eligibility Examples includes
a Claim 1 analysis that finds the claim eligible based on the
combination of additional elements integrating a mental process
into a practical application. [See 2019 Revised Patent Subject
Matter Eligibility Guidance, Subject Matter Eligibility
Examples: Abstract Ideas, pp. 1-3]. Like Appellant’s database
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and interactive voice response system, Claim 1 of Example 37
only includes generic computing components, like a graphical
user interface (GUI) and processor. However, when those
computing components are applied in specific method steps, a
patentable practical application results. Similarly, the detailed
method steps of Appellant’s independent claims integrate the
general components of a database and interactive voice
response system into a practical application.
Reply Br. 3 (emphasis added).
D.2.b.iii.
Further, in the Reply Brief, Appellant further newly contends:
Appellant’s database isn’t just a generic database. Appellant’s
database is “a database including probabilities of non-adherence
for combinations of patient types and medication types”. A
database configured for specific correlations is a specific
technical improvement that drives the other steps of the claimed
methods.
Reply Br. 3 (emphasis added).
D.2.c.i.
Appellant’s Appeal Brief argument is not persuasive. The search for a
practical application has also been referred to as the search for a
technological solution to a technological problem. See Amdocs (Isr.), Ltd. v.
Openet Telecom, Inc., 841 F.3d 1288, 1300 (Fed. Cir. 2016) (“[T]his claim
entails an unconventional technological solution . . . to a technological
problem . . . .”).
As acknowledged by Appellant, Appellant’s claim 1 is solving the
problem of “improved patient outreach for managing medication
adherence,” which is a personal behavior problem and not a technological
problem. We do not agree with Appellant that the “improved patient
outreach” is either a “technological field” or a “technological problem” or a
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“technological solution.” Rather, we determine that claim 1 is directed to
the field of following patient instructions and its problems and solutions.
Appellant’s argument is not persuasive.
The focus of claim 1 is not on an improvement in computer-
functionality, as in Enfish, but on an abstract idea that uses a computer as a
tool for improved patient outreach to manage medication adherence. Enfish,
LLC v. Microsoft Corp., 822 F.3d 1327 (Fed. Cir. 2016). Similarly, in
Trading Technologies, the Federal Circuit agreed with the district court
explanation that:
The claims require a specific, structured graphical user interface
paired with a prescribed functionality directly related to the
graphical user interface’s structure that is addressed to and
resolves a specifically identified problem in the prior state of the
art.
Trading Techs. Int’l, Inc. v. CQG, INC., 675 F. App’x 1001, 1004 (Fed. Cir.
2017). We do not find that here.
D.2.c.ii.
Appellant’s new “Example 37” Reply Brief argument is not
persuasive. First, in the Reply Brief, we find no meaningful explanation of
how Appellant deems “improved patient outreach” to manage medication
adherence has the effect of an “improved user interface” as in Example 37
(or the effect of any other improve computer or technological functionality).
Although Appellant analogizes claim 1 to the USPTO’s Example 37, we
determine that any such analogy is fanciful at best. Appellant’s claimed
patient outreach is simply not analogous to modifying icon placement as in
Example 37.
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D.2.c.iii.
Appellant’s new “database isn’t just a generic database” Reply Brief
argument is not persuasive. Essentially, Appellant is arguing that the
claimed database operates differently than a generic database because its
data is “‘probabilities of non-adherence for combinations of patient types
and medication types.’” Reply Br. 2. Particularly, Appellant asserts “[t]he
specific configuration of the database both improves the operation of the
method . . . [and] represents the use of a ‘particular machine’ for completing
the method steps.” Id. at 3. We disagree.
A specific data structure (i.e., a specific configuration of the database)
may improve computer functionality. Enfish, 822 F.3d at 1339 (“[T]he self-
referential table recited in the claims on appeal is a specific type of data
structure designed to improve the way a computer stores and retrieves data
in memory”). However, contrary to Appellant’s argument, merely storing
specific data in a generic database does not yield a specific data structure.
Rather, the data structure underlying the generic database remains
unchanged.
D.2.d.
We agree with the Examiner that as to claim 1, “the claim language
does not recite any improvements to the functioning of a computer, or to any
other technology or technical field.” Final Act. 6. In view of Appellant’s
Specification, and consistent with the Examiner’s determinations, we
conclude that claim 1 covers a disclosed embodiment that does not integrate
the judicial exception into a practical application. We determine claim 1
does not recite:
(i) an improvement to the functioning of a computer;
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(ii) an improvement to another technology or technical field;
(iii) an application of the abstract idea with, or by use of, a
particular machine;
(iv) a transformation or reduction of a particular article to a
different state or thing; or
(v) other meaningful limitations beyond generally linking the
use of the abstract idea to a particular technological
environment.
See MPEP §§ 2106.05(a)–(c), (e)–(h). We agree with the Examiner that
claim 1 is directed to a judicial exception, and does not integrate the judicial
exception into a practical application.
D.3. 2019 Revised Guidance Step 2B
The Examiner determines that in claim 1 the additional elements
perform functions that are “well-understood, routine and conventional.”
Final Act. 8.
Appellant contends:
Even if the claims as a whole were not found to be a practical
application, . . . their limitations are not well-understood,
routine, conventional activity in the field. . . . [U]sing initial
efficacy of specific medical therapies to schedule pharmacy
outreach is not well-understood in the art.
Appeal Br. 15 (emphasis added).
In Appellant’s claim 1, we find only abstract improvements to patient
outreach (using initial efficacy of specific medical therapies to schedule
pharmacy outreach) for managing medication adherence of the patient. A
claim directed to a unique and advantageous method for improved patient
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outreach is nonetheless directed to an abstract idea.6 “[U]nder the
Mayo/Alice framework, a claim directed to a newly discovered law of nature
(or natural phenomenon or abstract idea) cannot rely on the novelty of that
discovery for the inventive concept necessary for patent eligibility.” Genetic
Techs. Ltd. v. Merial L.L.C., 818 F.3d 1369, 1376 (Fed. Cir. 2016); see
Diehr, 450 U.S. at 188–89.
We determine that the Examiner correctly determines that in addition
to the abstract idea, claim 1 recites only well-understood, routine,
conventional elements/combination of elements previously known in the
industry. In view of Appellant’s Specification, and consistent with the
Examiner’s determinations, we determine that beyond the abstract idea, the
claims do not recite:
(vi) a specific limitation other than what is well-understood,
routine, conventional activity in the field or
unconventional steps that confine the claim to a particular
useful application.
See MPEP § 2106.05(d).

6 See Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709 (Fed. Cir. 2014). In
that case, the patentee argued that its financial arrangement (a method of
using advertising as an exchange or currency) was distinguishable from the
“routine,” “long prevalent,” or “conventional” abstract idea in Alice
because it was “directed to a specific method of advertising and content
distribution that was previously unknown.” Id. at 714. The court rejected
the patentee’s position that “abstract ideas remain patent-eligible under
§ 101 as long as they are new ideas, not previously well known, and not
routine activity.” Id.
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E. § 103 – Claim 1
We have reviewed the Examiner’s rejections in light of Appellant’s
arguments that the Examiner has erred. Appellant’s contentions we
discussed are dispositive as to the rejections on appeal. Therefore,
Appellant’s other contentions are not discussed in detail herein.
E.1.
As reproduced supra, part F.i. of claim 1 requires (emphasis added):
[F.] in response to the probability that the patient will not adhere
to the medication therapy:
[i.] identifying a first time after the patient receives the
filled prescription to call the patient based on an
initial efficacy of the medication therapy;
E.2.
In rejecting claim 1, the Examiner finds that the “based on an initial
efficacy of the medication therapy” limitation of part F.i. is taught by Miller.
Miller teaches a system and method wherein a time to contact a
patient who has received a patient is determined based upon
initial efficacy (e.g. initial response) to the medication. (par.
114–115[).]
Final Act. 15 (emphasis added).
E.3.
Appellant contends that the Examiner erred in rejecting claim 1 under
35 U.S.C. § 103 because:
The Examiner has failed to make a prima facie case of
obviousness due to a missing element in the combination of
references. None of Akers, Denenberg, Hanina or Miller disclose
or suggest the use of “initial efficacy” for determining an
outreach time after filling a prescription. The Examiner relies on
Miller for this element, where “a time to contact a patient . . . is
determined based on initial efficacy (e.g. initial response).”
[7/25/19 Office Action, p. 15]. However, “initial efficacy” and
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“initial response” are not equivalent. In plain meaning, efficacy
is having the intended effect of the treatment. The patient
responses cited by the Examiner in Miller are “potentially
adverse health outcomes” or side effects of the medication, not
initial efficacy. Drugs are not administered for their side effects;
they are administered for the intended therapeutic effect.
. . . Appellant’s specification distinguishes side effects and
initial efficacy. Independent claims 1 and 13 were narrowed by
amendment to be limited to “initial efficacy” rather than any
other clinically relevant time. By relying on the cited portions of
Miller, the Office Action does not accord proper scope to “initial
efficacy” under its plain meaning or as presented in the
specification.
Beyond the plain meaning, “efficacy” is used in medical
and pharmaceutical industries in distinct contrast with safety
(e.g. potentially adverse health outcomes). Distinct meanings
and management of efficacy versus safety are the basis of drug
regulations under the Food & Drug Administration, where, for
example, Phase I clinical trials focus on safety, while Phase II
clinical trials seek to establish efficacy. One of ordinary skill in
the art of managing pharmacy operations would readily
understand the distinction between “initial efficacy” and the cited
“potentially adverse health outcomes”.
Therefore, neither Miller, nor the other cited references,
disclose:
identifying a first time after the patient receives the
filled prescription to call the patient based on an
initial efficacy of the medication therapy [Claims
1 and 13]
and a prima facie case of obviousness has not been made.
Appeal Br. 16–17.
E.4.
As articulated by the Federal Circuit, the Examiner’s burden of
proving non-patentability is by a preponderance of the evidence. See In re
Caveney, 761 F.2d 671, 674 (Fed. Cir. 1985) (“[P]reponderance of the
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20
evidence is the standard that must be met by the PTO in making rejections”).
“A rejection based on section 103 clearly must rest on a factual basis[.]” In
re Warner, 379 F.2d 1011, 1017 (CCPA 1967). “The Patent Office has the
initial duty of supplying the factual basis for its rejection. It may not . . .
resort to speculation, unfounded assumptions or hindsight reconstruction to
supply deficiencies in its factual basis.” Id. We conclude the Examiner’s
analysis fails to meet this standard because the rejection does not adequately
explain the Examiner’s findings of fact.
E.5.
We agree with Appellant that the meaning of the term “efficacy” as
used in claim 1 precludes the Examiner’s “adverse outcome” based claim
interpretation. Ans. 32. Appellant’s use of the term “efficacy” is consistent
with Dictionary.com,7 which states that the term “efficacy” means:
1) capacity for producing a desired result or effect; effectiveness.
2) the quality of being successful in producing an intended result;
effectiveness.
Contrary to the Examiner’s finding, we conclude that an artisan would
understand the term “efficacy” to require a “desired result” or an “intended
result.”
We conclude, consistent with Appellant’s argument, that there is
currently insufficient articulated reasoning to support the Examiner’s finding

7 Dictionary.com, https://www.dictionary.com/browse/efficacy#. The
Random House Dictionary of the English Language (2nd Ed. Unabridged;
1987); and Collins English Dictionary - Complete & Unabridged 2012
Digital Edition © William Collins Sons & Co. Ltd. 1979, 1986 ©
HarperCollins Publishers 1998, 2000, 2003, 2005, 2006, 2007, 2009, 2012
(Accessed March 5, 2021).
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that Miller (in combination with Akers, Denenberg, and Hanina) teaches,
suggests, or otherwise renders obvious part F.i. as required by claim 1.
Therefore, we conclude that there is insufficient articulated reasoning
to support the Examiner’s final conclusion that claim 1 would have been
obvious to one of ordinary skill in the art at the time of Appellant’s
invention.

CONCLUSION
The Examiner has not erred in rejecting claims 1–7, 10–17, 19, and 20
under 35 U.S.C. § 101, as being directed to patent-ineligible subject matter.
Appellant has shown that the Examiner erred in rejecting claims 1–7,
10–17, 19, and 20 as being unpatentable under 35 U.S.C. § 103(a).
The Examiner’s rejection of claims 1–7, 10–17, 19, and 20 under
35 U.S.C. § 101, as being directed to patent-ineligible subject matter, is
affirmed.
The Examiner’s rejection of claims 1–7, 10–17, 19, and 20 as being
unpatentable under 35 U.S.C. § 103(a) is reversed.
Because at least one rejection encompassing all claims on appeal is
affirmed, the decision of the Examiner is affirmed.

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22
DECISION SUMMARY
In summary:
Claim(s)
Rejected
35 U.S.C. § Reference(s)/Basis  Affirmed Reversed
1–7, 10–17,
19, 20
101 Eligibility 1–7, 10–
17, 19, 20

1–7, 10–17,
19, 20
103(a) Akers, Denenberg,
Hanina, Miller
1–7, 10–
17, 19, 20
Overall
Outcome

1–7, 10–
17, 19, 20

TIME PERIOD FOR RESPONSE
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