Keeling, Peter et al.

Patent Trials and Appeals Board

Mar 31, 2020

11517591 - (D) (P.T.A.B. Mar. 31, 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.
11/517,591 09/08/2006 Peter Keeling 100376-0102 9862
22428 7590 03/31/2020
FOLEY & LARDNER LLP
3000 K STREET N.W.
SUITE 600
WASHINGTON, DC 20007-5109
EXAMINER
MISIASZEK, AMBER ALTSCHUL
ART UNIT PAPER NUMBER
3624
NOTIFICATION DATE DELIVERY MODE
03/31/2020 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):
ipdocketing@foley.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte PETER KEELING and DAVE SMART
____________

Appeal 2019-000123
Application 11/517,591
Technology Center 3600
____________

Before BIBHU R. MOHANTY, AMEE A. SHAH, and
MATTHEW S. MEYERS, Administrative Patent Judges.

MEYERS, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner’s
Final Rejection of claims 52–57, 61–67, 70–75, and 79–82, which constitute
all the claims pending in this application. Claims 1–51, 58–60, 68, 69, and
76–78 have been cancelled. We have jurisdiction under 35 U.S.C. § 6(b).

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 February 23, 2018) and Reply Brief (“Reply Br.,” filed October 2,
2018), and the Examiner’s Answer (“Ans.,” mailed August 3, 2018) and
Final Office Action (“Final Act.,” mailed March 9, 2017). Appellant
identifies the real party in interest as “Diaceutics” (Appeal Br. 3).
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We AFFIRM.
CLAIMED INVENTION
Appellant’s claims relate to “a method and system for developing a
personali[z]ed medicine business plan.” Spec. 1, ll. 6–7.
Claims 52, 67, 70, and 71 are the independent claims on appeal.
Claim 52, reproduced below, is illustrative of the claimed subject matter:
52. A method for developing a personalized medicine
business plan for adopting a diagnostic and therapy combination,
the method comprising:
(a) calculating a data set of variables associated with a
personalized medicine business plan, wherein the variables
comprise personalized medicine revenue driver values, and
wherein the personalized medicine revenue driver values
comprise:
A. the number of patients placed on the therapy;
B. the potential market size for the therapy from an
indication of the number of patients that could be
placed on the therapy and an allocated value for each
patient;
C. the uptake of the diagnostic;
D. a correction of the potential market of the combined
therapy and diagnostic in accordance with the uptake
of the combination;
E. the opportunity to test index; and
F. the theranostic uptake increase slope,
wherein the personalized medicine revenue driver
values are calculated based on the precedents in a
case-study archive related to a diagnostic test that aids
therapy selection;
(b) predicting a revenue or financial target based on the
variables using a computer;
(c) generating a hypothetical business scenario from the
predicted revenue or financial target using a computer;
(d) comparing the hypothetical business scenario to an
archive of scenarios, wherein the archive of scenarios comprises
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data and calculations therefrom acquired from real-world case
studies relating to the disease, patients having the disease, the
therapy, the diagnostic, and/or the combination of the therapy
and the diagnostic;
(e) identifying a scenario from the archive of scenarios that
most closely matches the hypothetical business scenario; and
(f) providing one or more guidance parameters assessing
the effect of the diagnostic on the adoption of the therapy in the
personalized medicine business plan.

REJECTIONS
1. Claims 52–57, 61–67, 70–75, and 79–82 are rejected under
35 U.S.C. § 101 as directed to a judicial exception without significantly
more.
2. Claims 52–57, 61–67, 70–75, and 79–82 are rejected under
35 U.S.C. § 103(a) as being unpatentable over Eder (US 2005/0246314 A1,
pub. Nov. 3, 2005), Macrae (US 2003/0093310 A1, pub. May 15, 2003), and
Peter Keeling, MBA, Integrating Diagnostics and Therapeutics for Targeted
Therapies, Part 1: Optimizing the Comarketing Plan, April 29, 2005
(“Keeling1”).

ANALYSIS
Patent-Ineligible Subject Matter
Appellant argues claims 52–57, 61–67, 70–75, and 79–82 as a group.
Appeal Br. 7–12; Reply Br. 3–4. We select independent claim 52 as
representative. The remaining claims stand or fall with claim 52. See
37 C.F.R. § 41.37(c)(1)(iv).
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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.
Id. 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
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.
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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. (citation omitted)
(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.”).
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.
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B. USPTO Section 101 Guidance
In January 2019, the U.S. Patent and Trademark Office (USPTO)
published revised guidance on the application of § 101. 2019 Revised Patent
Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019)
(“2019 Revised Guidance”).2 “All USPTO personnel are, as a matter of
internal agency management, expected to follow the guidance.” Id. at 51;
see also October 2019 Update at 1.
Under the 2019 Revised Guidance and the October 2019 Update, 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 (see MPEP § 2106.05(a)–(c), (e)–(h) (9th ed.
Rev. 08.2017, Jan. 2018)) (“Step 2A, Prong Two”).3
2019 Revised Guidance, 84 Fed. Reg. at 52–55.

2 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”) (available at
https://www.uspto.gov/sites/default/files/documents/peg_oct_2019_update.p
df).
3 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. See 2019 Revised Guidance - Section III(A)(2), 84
Fed. Reg. 54–55.
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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” in the field (see MPEP
§ 2106.05(d)); or
(4) simply appends well-understood, routine, conventional activities
previously known to the industry, specified at a high level of
generality, to the judicial exception.
2019 Revised Guidance, 84 Fed. Reg. at 52–56.
Step One of the Mayo/Alice Framework
With regard to the first step of the Mayo/Alice framework and
Step 2A, Prong One of the 2019 Revised Guidelines, 84 Fed. Reg. at 54, the
Examiner determines that exemplary independent claim 52 broadly recites
“developing a personalized medicine business plan.” Final Act. 4; Ans. 3.
More particularly, the Examiner states that the limitations of independent
claim 52 “are directed to developing a personalized business plan by
calculating the variables associated with the personalized business plan,
predicting revenue, comparing the hypothetical business scenario to an
archive of scenarios in order to provide the guidance parameters as described
in the [S]pecification.” Final Act. 5. The Examiner considers this to be an
abstract idea, inasmuch as the claimed concept is “similar to that of
organizing information through mathematical correlations, which is one of
the concepts found by the courts to be an abstract idea.” Id.
In response, Appellant argues that independent claim 52 is not
directed to an abstract idea because the “claims account for considerably
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more than ‘calculating, comparing and providing steps.’” Appeal Br. 8.
According to Appellant, the Examiner erred in oversimplifying the steps
recited in independent claim 52 without considering the claims as a whole.
Id.
We are not persuaded that the Examiner erred in determining that
independent claim 52 is directed to an 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 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 entitled “Method and System for Developing a
Personalised Medicine Business Plan” (emphasis omitted), and states that
the disclosure “relates to a method and system for developing a
personali[z]ed business plan.” Spec. 1, ll. 6–7. According to the
Specification, “[p]ersonali[z]ed medicine refers to the use of a test (or
diagnostic) to target a drug (or therapy) at patients that are most likely to
benefit therefrom, or to identify patients who may be at risk of harm from
said therapy.” Id. at 1, ll. 11–13. The Specification discloses that “a
personali[z]ed medicine business model requires interdisciplinary
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collaboration between the traditionally separate diagnostics and
pharmaceutical industries” (id. at 2, ll. 20–22), and further describes that
“the logistic and commercial challenges of co-marketing of a diagnostic with
a therapy mean that pharmaceutical companies must seriously consider
whether a personali[z]ed medicine business model will provide sufficient
commercial return to justify a change from their traditional blockbuster
model.” Id. at 3, ll. 2–6.
The Specification notes, however, that “in view of the relatively
recent emergence of personali[z]ed medicine, there is a lack of precedents
for assessing such models” (id. at 3, ll. 6–8), and indicates that the lack of
precedents “makes it difficult for decision makers to estimate the return on
investment (ROI) from a personali[z]ed medicine business plan.” Id. at 3,
ll. 8–10. To address these drawbacks, the present invention provides a
“hybrid predictive-modelling case-based reasoning approach for predicting
revenue from a personalized medicine business plan and validating the
same.” Id. at 11, ll. 29–12, ll. 1.
Consistent with this disclosure, independent claim 52 recites a method
comprising steps for: (1) calculating variables comprising revenue driver
values and predicting a revenue or financial target based on the calculated
variables, i.e., “calculating a data set of variables” and “predicting a review
of financial target” (steps (a), (b)); (2) generating a hypothetical business
scenario, comparing the hypothetical business scenario to archived
scenarios, and identifying an archived scenario that most closely matches the
hypothetical business scenario, i.e., “generating a hypothetical business
scenario,” “comparing the hypothetical business scenario to an archive of
scenarios,” and “identifying a scenario from the archive of scenarios” (steps
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(c)–(e)); and (3) providing guidance parameters for assessing the effect of
the diagnostic on the adoption of the therapy, i.e., “providing one or more
guidance parameters” (step (f)).
Upon reviewing the Specification and independent claim 52, as
summarized above, we agree with the Examiner that independent claim
52 recites broadly a series of steps for “developing a personalized medicine
business plan.” (Final Act. 4), which can be characterized as a certain
method of organizing human activity. Here, independent claim 52 predicts a
revenue target based on calculated personalized medicine revenue driver
values (steps (a), (b)), identifies an archived scenario by generating a
hypothetical business scenario and comparing the hypothetical business
scenario to archived scenarios (steps (c)–(e)), and then provides assessment
parameters (step (f)). In other words, claim 52 broadly recites a method for
developing a personalized medicine plan by calculating, predicting,
generating, comparing, identifying, and providing medicine business plan
information.
Thus, it is clear that independent claim 52 recites a form of
commercial interaction that, under the 2019 Revised Guidance, falls under
the category of “[c]ertain methods of organizing human activity” and more
specifically “commercial or legal interactions (including agreements in the
form of . . . sales activities or behaviors; business relations).” 2019 Revised
Guidance, 84 Fed. Reg. at 52. Accordingly, independent claim 52 recites an
abstract idea. Cf. Univ. of Fla. Research Found., Inc. v. Gen. Elec. 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”);
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Intellectual Ventures I LLC v. Capital One Fin. Corp., 850 F.3d 1332, 1339–
40 (Fed. Cir. 2017) (claim for manipulating XML documents by organizing,
identifying, mapping, defining, and modifying data was directed to the
abstract idea of “collecting, displaying, and manipulating data”); and
Electric Power Grp., 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”).
Having concluded that claim 52 recites a judicial exception, i.e., an
abstract idea, we turn to the Step 2A, Prong Two of the 2019 Revised
Guidance and determine whether the claim integrates the recited judicial
exception into a practical application of the judicial exception. Here we look
to see if, for example, any additional elements of the claim (i) reflect an
improvement in the functioning of a computer or to another technological
field, (ii) implement the judicial exception with, or by use of, a particular
machine, (iii) effect a transformation or reduction of a particular article to a
different state or thing, or (iv) use the judicial exception in some other
meaningful way beyond generally linking the use of the judicial exception to
a particular technological environment. See 2019 Revised Guidance, 84
Fed. Reg. at 55; see also MPEP §§ 2106.05(a)–(c), (e)–(h).
Here, the only additional element recited in claim 52 beyond the
abstract idea is “a computer,” which is limited to the “predicting” and
“generating” steps. However, the additional element is described generically
in the Specification (see, e.g., Spec. 27, ll. 12–15). We find no indication in
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the Specification, nor does Appellant direct us to any indication, that the
steps recited in claim 52 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 computer technology and/or functionality to the claimed
invention or that otherwise indicates that the claimed invention integrates the
abstract idea into a “practical application,” as that phrase is used in the
2019 Revised Guidance.4
Appellant argues that independent claim 52 solves a specific
technological problem. Appeal Br. 8–10. Appellant attributes this purported
technical improvement as enabling “pharmaceutical companies to optimize
the net present value of a targeted therapeutic by indicating how to most

4 The 2019 Revised Guidance references MPEP § 2106.05(a)–(c) and (e) in
describing the 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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efficiently allocate resources in a specific situation,” and as such, addresses a
technical problem in the industry by “coordinating the co-marketing of a
therapeutic and companion diagnostic.” Id. 9–10.
Appellant’s argument is not persuasive. Here, the focus of
independent claim 52 is not on any technological advancement, but rather on
the implementation of the abstract idea, “for which computers are invoked
merely as a tool.” See Enfish, 822 F.3d at 1336. In this regard, the
Specification merely discloses that
Software, web, and computer readable data storage
implementations of the various embodiments and method steps
described herein can be accomplished with methods known in
the art including programming techniques with rule based logic
and other logic.
Spec. 27, ll. 12–15.
Independent claim 52, unlike the claims found non-abstract in prior
cases, uses generic computer technology to predict a revenue or financial
target and generate a hypothetical business scenario, and does not recite an
improvement to a particular computer technology. See 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”).
Appellant also argues that the present claims are patent eligible in
view of Trading Technologies Int’l, Inc. v. CQG, Inc., 675 F. App’x 1001
(Fed. Cir. 2017) because the “claimed method addresses this particular
technical problem in this specific industry.” Appeal Br. 10. We disagree.
In Trading Technologies, the district court found that the claimed
devices “have no ‘pre-electronic trading analog,’” and “do not simply claim
displaying information on a graphical user interface.” 675 Fed. App’x at
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1004. The court concluded “the claimed subject matter is ‘directed to a
specific improvement to the way computers operate,’ . . . for the claimed
graphical user interface method imparts a specific functionality to a trading
system ‘directed to a specific implementation of a solution to a problem in
the software arts.’” Id. at 1006. We distinguish the claims before us from
those in Trading Technologies, because, unlike in Trading Technologies,
independent claim 52 merely ultizes a generic and conventional “computer.”
Spec. 27, ll. 12–15. Independent claim 52 does not overcome a problem
associated with prior art computers or improve the way computers operate.
Instead, independent claim 52 simply addresses a business problem related
to “coordinating the co-marketing of a therapeutic and companion
diagnostic.” Appeal Br. 10.
Based on the above, we conclude that independent claim 52 recites a
method of organizing human activity, i.e., an abstract idea, and that the
additional elements recited in the claim are no more than generic
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.’”) (alterations in original) (quoting
Mayo, 566 U.S. at 77). Accordingly, we agree with the Examiner that
independent claim 52 is directed to an abstract idea.
Having determined under step one of the Mayo/Alice framework that
claim 52 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 52 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 the Examiner has failed to “show that the
pending claims are ‘well understood, routing or conventional’ as required by
Berkheimer v. HP Inc., 881 F.3d 1360 (Fed. Cir. 2018) and Aatrix Software,
Inc. v. Green Shades Software, Inc., 882 F.3d 1121 (Fed. Cir. 2018). Reply
Br. 3–4. However, “the relevant inquiry is not whether the claimed
invention as a whole is unconventional or non-routine.” BSG Tech LLC v.
BuySeasons, Inc., 899 F.3d 1281, 1290 (Fed. Cir. 2018). Instead, the
question is whether the claim includes additional elements, i.e., elements
other than the abstract idea itself, that “‘transform the nature of the claim’
into a patent-eligible application.” Alice Corp., 573 U.S. at 217 (quoting
Mayo, 566 U.S. at 79, 78).
Here, the Examiner determines that the additional limitations of
claim 52 “include a computer system.” Ans. 5. The Examiner further
determines that the additional elements “are merely generic computing
elements performing generic computing functions as described in the
[S]pecification,” and as such, do not “amount[]to ‘significantly more’ than
the abstract idea. Id.
We agree with the Examiner that the steps performed by the
“computer” of independent claim 52 are well-understood, routine, or
conventional. As discussed above, there is nothing in the Specification to
indicate that the steps recited in claim 52 require any specialized hardware
or inventive computer components or that the claimed invention is
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implemented using anything other than a generic computer to perform
generic computer functions, e.g., predicting and generating.
Viewed as a whole, independent claim 52 simply recites a series of
steps instructing how to predict revenue, identify a matching scenario, and
provide guidance parameters. See Ultramercial, Inc. v. Hulu, LLC, 772 F.3d
709, 716 (Fed. Cir. 2014) (“[T]he claimed sequence of steps comprises only
‘conventional steps, specified at a high level of generality,’ which is
insufficient to supply an ‘inventive concept.’”) (Citing Alice, 134 S. Ct. at
2357). Here, independent claim 52 does not, for example, purport to
improve the functioning of the computer itself. Nor does it effect an
improvement in any other technology or technical field, as discussed above
with respect to Prong Two of Step 2A. Instead, independent claim 52
amounts to nothing significantly more than an instruction to apply the
abstract idea using a generic computer , which under our precedents, is not
enough to transform an abstract idea into a patent-eligible invention. See
Alice, 134 S. Ct. at 2360.
We also are not persuaded by Appellant’s argument that “it is
inaccurate to state that the functions being performed are ‘generic’” (Appeal
Br. 11) or that “[t]he Examiner has failed to make any supporting citation or
take official notice” that the recited steps are well-understood, routine, and
conventional in the field. Reply Br. 3–4. At the outset, we note that the
Federal Circuit, in accordance with Alice, has “repeatedly recognized the
absence of a genuine dispute as to eligibility” where claims have been
defended as involving an inventive concept based “merely on the idea of
using existing computers or the Internet to carry out conventional processes,
with no alteration of computer functionality.” Berkheimer, 890 F.3d at 1373
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(Moore, J., concurring); see also BSG Tech, 899 F.3d at 1291 (“BSG Tech
does not argue that other, non-abstract features of the claimed inventions,
alone or in combination, are not well-understood, routine and conventional
database structures and activities. Accordingly, the district court did not err
in determining that the asserted claims lack an inventive concept.”).
Moreover, as discussed in greater detail above, there is no indication in the
record that the “computer” requires any specialized computer hardware or
that it requires any programming atypical from conventional programming.
Instead, the Specification discloses utilizing a conventional computer (see,
e.g., Spec. 27, ll. 12–15). See Bancorp Services v. Sun Life, 687 F.3d 1266,
1278, (Fed. Cir. 2012) (“The computer required by some of Bancorp’s
claims is employed only for its most basic function, the performance of
repetitive calculations, and as such does not impose meaningful limits on the
scope of those claims.”).
We are similarly unpersuaded by Appellant’s argument that the
present claims are similar to the patent-eligible claims in McRO because
“[t]he claims provide specific rules and inputs that create a desired result”
Appeal Br. 12. We cannot agree.
In McRO, the Federal Circuit premised its determination that the
claims were patent-eligible, not merely on the specificity of the claimed
animation scheme, but rather on the fact that the claims, when considered as
a whole, were directed to a technological improvement over the existing,
manual 3-D animation techniques and used limited rules in a process
specifically designed to achieve an improved technological result in
conventional industry practice. We are not persuaded that a comparable
situation is presented here. As our reviewing court has made clear, “relying
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on a computer to perform routine tasks more quickly or more accurately is
insufficient to render a claim patent eligible.” OIP Techs., Inc. v.
Amazon.com, Inc., 788 F.3d 1359, 1363 (Fed. Cir. 2015).
We further note that there is a fundamental difference between
technological or computer functionality improvements, on the one hand, and
uses of existing computers as tools to perform a particular task, on the other.
Here, the Specification discloses that “implementations of the various
embodiments and method steps described herein can be accomplished with
methods known in the art including programming techniques with rule based
logic and other logic.” Spec. 27, ll. 12–15. Indeed, the Federal Circuit
applied this distinction in Enfish, 822 F.3d at 1335–36 in rejecting a § 101
challenge at the step one stage of the Mayo/Alice analysis because the claims
at issue focused on a specific type of data structure, i.e., a self-referential
table for a computer database, designed to improve the way a computer
carries out its basic functions of storing and retrieving data, and not on
asserted advances in uses to which existing computer capabilities could be
put. Id.
Finally, Appellant argues that the present claims “are related
specifically to personalized medicine” and “do not preempt processes
outside of this field.” Appeal Br. 12. Appellant’s preemption argument
does not, however, alter our § 101 analysis. Preemption concerns are fully
addressed and made moot where a patent’s claims are deemed to disclose
patent ineligible subject matter under the two-part framework described in
Mayo and Alice. Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371,
1379 (Fed. Cir. 2015). “While preemption may signal patent ineligible
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matter, the absence of complete preemption does not demonstrate patent
eligibility.” Id.
Appellant’s other arguments, including those directed to now-
superseded USPTO guidance, have been considered but are not persuasive
of error. (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.”))).
We are not persuaded, on the present record, that the Examiner erred
in rejecting independent claim 52 under 35 U.S.C. § 101. Therefore, we
sustain the Examiner’s rejection of independent claim 52, and claims 53–57,
61–67, 70–75, and 79–82, which fall with independent claim 52.

Obviousness
We are persuaded by Appellant’s argument that the Examiner erred in
rejecting independent claims 52, 67, 70, and 71 under 35 U.S.C. § 103(a)
because Keeling1, upon which the Examiner relies, fails to disclose or
suggest “calculating a data set of variables associated with a personalized
medicine business plan, wherein the variables comprise personalized
medicine revenue driver values, and wherein the personalized medicine
revenue driver values comprise: the theranostic uptake increase slope,” as
recited by limitation (a)(F) of independent claim 52, and similarly recited by
independent claims 67, 70, and 71. Appeal Br. 12–14; Reply Br. 5–6.
The Examiner maintains that the rejection is proper, and cites
Keeling1, as disclosing “[t]he calculation steps.” Ans. 9 (citing Keeling1, 3-
2–3-13); Final Act. 9 (citing Keeling1, 3-9–3-13). However, we agree with
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Appellant that there is nothing in the cited portions that discloses or suggests
the argued limitation.
In making this determination, we note that Keeling1 is directed to the
“comarketing of diagnostics and therapeutics.” Keeling1, 3-1. Keeling1
discloses the emergence of “theranostics (combined diagnostics and therapy)
and personalized medicine (targeted therapy)”. Id. at 3-2. For example,
Keeling1 describes that “a combined test-and-treatment approach to a
medical condition is likely to elevate the market share of such a drug.” Id. at
3-8–3-9. Keeling1 further describes that by enabling joint marketing and
avoiding “the expensive need to build separate diagnostic brand equity,
pharmaceutical companies should ask their diagnostic partners to orient their
marketing spend toward the brand objectives of the therapy.” Id. at 3-10.
Keeling1 notes, however, that “resistance to the diagnosing process will
hinder the uptake of the drug – from creating a delay in prescribing to
causing a bottleneck in disease management” (id.), and asserts that “[a] joint
budget can allocate resources toward total market development (in
particular, to diagnosis or monitoring bottlenecks), not only to uptake of the
therapy.” Id. at 3-12.
We have reviewed the cited portions of Keeling1 and agree with
Appellant that none of the cited portions of Keeling1, alone or in
combination, discloses or suggests the argued limitation. Instead, we agree
with Appellant that, although Keeling1 generally discloses co-marketing of
therapeutics and diagnostics, Keeling1 “does not teach or suggest the
limitations of . . . how to calculate uptake increase slope,” as required by
limitation (a)(F) of independent claim 52, and similarly required by
independent claims 67, 70, and 71. Appeal Br. 13; Reply Br. 5. We further
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agree with Appellant that Keeling1 does not “teach any of the expressly
recited variables that one would use in the calculation of” the theranostic
uptake increase slope, as defined by the Specification. Appeal Br. 14.
In responding to Appellant’s arguments, the Examiner broadly takes
the position that the “calculation steps claimed are part of business analyses
and marketing research covered by Keeling1 in developing a business plan
for personalized medicine, and are taught by Keeling1 and further outlined
in Table 1 and the corresponding scenarios described in Keeling 1 at pages
3-7 and 3-8.” Ans. 9. Although we agree with the Examiner that Keeling1
broadly discloses developing a business plan for personalized medicine
based on business and marketing analyses (id.), we cannot agree with the
Examiner that Keeling1 discloses “calculating . . . the theranostic uptake
increase slope,”as required by independent claim 52.
In this regard, we note that the Specification defines calculating an
uptake increase slope of the theranostic by combining a calculated
diagnostic uptake increase slope (%/yr) with user inputs of a diagnostic
launch year, a diagnostic uptake start value (%), and a maximum level of
diagnostic uptake. Spec. 21, ll. 4–8. Although Keeling1 generally discusses
drug and therapy uptake, Keeling1 does not disclose “calculating . . . the
theranostic uptake increase slope,” under a broadest reasonable
interpretation consistent with Appellant’s Specification. Specifically,
Keeling1 discloses therapy uptake, in general terms, without disclosing a
theranostic uptake increase slope calculation or describing any of the
relevant calculation inputs identified in the Specification.
In view of the foregoing, we do not sustain the Examiner’s rejection
of independent claims 52, 67, 70, and 71 under 35 U.S.C. § 103(a). For the
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same reasons, we also do not sustain the Examiner’s rejection of dependent
claims 53–57, 61–66, 72–75, and 79–82, which are not argued separately.

CONCLUSION
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
52–57, 61–
67, 70–75,
79–82
101 Eligibility 52–57, 61–
67, 70–75,
79–82

52–57, 61–
67, 70–75,
79–82
103 Eder, Macrae,
Keeling1
52–57,
61–67,
70–75,
79–82
Overall
Outcome
52–57, 61–
67, 70–75,
79–82

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