null

Patent Trials and Appeals Board

Nov 7, 2019

12441184 - (D) (P.T.A.B. Nov. 7, 2019)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
12/441,184 03/13/2009 Yasser Alsafadi 2006P01169WOUS 9850
24737 7590 11/07/2019
PHILIPS INTELLECTUAL PROPERTY & STANDARDS
465 Columbus Avenue
Suite 340
Valhalla, NY 10595
EXAMINER
SEREBOFF, NEAL
ART UNIT PAPER NUMBER
3626
NOTIFICATION DATE DELIVERY MODE
11/07/2019 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
katelyn.mulroy@philips.com
marianne.fox@philips.com
patti.demichele@Philips.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte YASSER ALSAFADI
Appeal 2019-000810
Application 12/441,184
Technology Center 3600
Before KARL D. EASTHOM, AMBER L. HAGY, and
KARA L. SZPONDOWSKI, Administrative Patent Judges.
EASTHOM, Administrative Patent Judge.
DECISION ON APPEAL

Appeal 2019-000810
Application 12/441,184

2
I. STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision finally rejecting claims 1–13 in a Final Office Action.
Final Act. 1. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
II. DISCLOSED AND CLAIMED SUBJECT MATTER
The Specification describes a molecular diagnostics decision support
system. Spec. 1:1–5.2 The support system interconnects databases and
software components in order to create information, namely, patient related
information (PRI). See Spec., Fig. 1, 8:10–12. According to the
Specification, “the present invention does not provide a diagnosis as part of
the patient related information PRI. Rather, the invention provides
information PRI that can assist a physician, a clinician, and/or a technician
in reaching a diagnosis.” Spec. 8:10–12 (emphasis added).
Claim 1, reproduced below, illustrates the claimed subject matter:
1. A molecular diagnostics decision support system (MD-
DSS) for providing patient related information (PRI), the system
comprising:
a molecular diagnostic measurement device that generates
a gene expression of a biopsy sample of a patient,
a patient information database (EMJ) storing patient data
about the patient,

1 “Appellant” here constitutes an “applicant” as defined in 37 C.F.R.
1.42(a). Appellant identifies the real party in interest as Koninklijke Philips,
N.V. Appeal Br. 3.
2 The record USPTO filing system includes three copies of Specifications.
We refer to the Specification having the following nomenclature:
PH00578US1 bearing the following date: “28.08.2006.” The three
Specifications appear to be materially the same.
Appeal 2019-000810
Application 12/441,184

3
a data input section (DAT) that receives the gene
expression, as input data (MDx), from the molecular diagnostic
measurement device,
a clinical guideline database (CL),
a knowledge database (KB),
a first decision support mechanism (1DSM),
a second decision support mechanism (2DSM),
an inference engine (IE), and
a middleware (MW) section interconnecting the patient
information database (EMJ), the data input section (DAT), the
clinical guideline database (CL), the knowledge database (KB),
the first decision support mechanism (1DSM), and the second
decision support mechanism (2DSM),
wherein the inference engine (IE) is configured to classify
asserted facts in the knowledge base (KB) to determine a correct
position of a class of classes in a hierarchy using logical
definitions of the classes,
wherein the first (1DSM) and the second (2DSM) decision
support mechanisms process input data (MDx) into patient
related information (PRI) using the patient information database
(EMJ), the clinical guideline database (CL) and the knowledge
database (KB), and
wherein the first (1DSM) and the second (2DSM) decision
support mechanism are operably coupled through the
middleware (MW) so as to interact during the processing of the
input data (MDx).
III. REFERENCES
The Examiner relies upon the following prior art:
Name Reference Date
Avinash US 2004/0122787 A1 June 24, 2004
Lu WO 03/017038 A2 Feb. 27, 2003
IV. REJECTIONS
Claims
Rejected
35 U.S.C. § Reference(s)/Basis
1–12 112 2nd Indefiniteness
1–13 112 1st Written Description
Appeal 2019-000810
Application 12/441,184

4
Claims
Rejected
35 U.S.C. § Reference(s)/Basis
1–13 101 Nonstatutory Subject Matter
13 102 Anticipation, Avinash
1–12 103 Obviousness, Avinash and Lu
V. OPINION
As set forth in the table above, the Examiner rejects claims 1–13 for
reciting nonstatutory subject matter and lack of written description, claims
1–12 for indefiniteness and obviousness, and claim 13 for anticipation.
We primarily cite the Final Action and Appeal Brief in support of this
Decision. Nonetheless, we considered all the briefing in reaching the
Decision, including the Examiner’s Answer and Appellant’s Reply Brief,
which largely emphasizes certain points in the Appeal Brief.
A. Claim Construction, 35 U.S.C. § 112, Sixth Paragraph
The Examiner construes three claim 1 limitations, “decision support
mechanism,” “interference engine,” and “middleware section,” as falling
under 35 U.S.C. § 112, sixth paragraph, because “they use a generic
placeholder ‘engine,’ ‘mechanism’ and ‘section’ coupled with functional
language ‘process’ and ‘for’ without reciting sufficient structure to
achieve the function.” Final Act. 3. The Examiner explains “the generic
placeholder is not preceded by a structural modifier.” Id.
Under 35 U.S.C. § 112, sixth paragraph:
An element in a claim for a combination may be expressed
as a means or step for performing a specified function without
the recital of structure, material, or acts in support thereof, and
such claim shall be construed to cover the corresponding
structure, material, or acts described in the specification and
equivalents thereof.

Appeal 2019-000810
Application 12/441,184

5
Appellant initially notes that “because the term ‘means for . . .’ is not
recited with respect to any of these limitations in claim 1, a rebuttable
presumption arises that 35 U.S.C 112, sixth paragraph, does not apply.”
Appeal Br. 6 (emphasis omitted). Appellant “submit[s] that the Office
Action has not successfully rebutted this presumption, i.e., that the terms do
provide sufficient structure for performing the corresponding functions,
when considered in light of the [S]pecification and commonly accepted
meanings in the technological art.” Id. (emphasis omitted).
Contrary to Appellant’s argument, nothing in the Specification or
record indicates that the terms “decision support mechanism,” “interference
engine,” and “middleware section,” invoke a commonly accepted meaning
in the art. As the Examiner reasons, “[t]he problem is that the Appellant’s
[S]pecification does not particularly point out what the invention
comprises.” Ans. 3. The Examiner directs attention to the Specification at
page 9, lines 1–13. See Final Act. 3. That section describes a first and
second “decision support mechanism” as implementing a “Genetic
Algorithm” (GA), or as using a “Bayesian” or “a Fuzzy logic based network
to resolve a criterion in a decision step,” with the two support mechanisms
including “tight couplings.” See Spec. 9:1–13.
Page 9 of the Specification also describes an “inference engine IE
[that] will classify the asserted facts in the knowledge base KB to find the
correct position of a class in a hierarchy using the logical definition of the
classes.” Id. at 9:25–27.3 It further describes the “inference engine IE” as a
“generic component[] of a decision support system” with “no specific

3 In some instances, the Specification refers to the same component as an
“interference engine IE.” See, e.g., Spec. 9:18. Claim 9 also recites an
Appeal 2019-000810
Application 12/441,184

6
requirements for a molecular diagnosis application.” Id. at 9:19–23. It
states “Racer is an example inference engine” and “[i]t should be
consider[ed] to use available off the shelf components for these engines IE
and CL-EE.” Id. at 9:28–29.
Page 8 of the Specification states “[t]he middleware section MW
interconnecting the elements of the DSS can include any kind of connection
including, but not limited to, electrical connections and wireless
connections.” Id. at 8:21–23 (emphasis added). Page 7 of the Specification
describes the middleware section as follows:
The middleware MW section 110 interconnects the patient
information database EMJ, the data input section DAT, the
clinical guideline database CL, the knowledge database KB, the
first decision support mechanism 1DSM, and the second decision
support mechanism 2DSM. As such the other components
depicted in Fig. 1 may be considered to be embedded in the
middleware MW, but for practical considerations the
middleware section MW enables the communication by
electric/wireless connections and control this communication.
Id. at 7:20–26.
These Specification passages support the Examiner’s findings. They
show that the terms “decision support mechanism,” “inference engine,” and
“middleware section” fall under 35 U.S.C. § 112, sixth paragraph. Contrary
to Appellant’s arguments, nothing in the Specification shows that an artisan
of ordinary skill would have recognized the terms as connoting well-known

“interference engine (IE).” The term “interference engine” appears to be a
typographical mistake that Appellant should address in any subsequent
prosecution. Accordingly, throughout this Decision, we treat the disclosed
and claimed “interference engine” and “inference engine” as the same, and
with the exception of quoting the briefs or the Specification, we refer only to
the latter for discussion purposes.
Appeal 2019-000810
Application 12/441,184

7
or sufficient structure. See Appeal Br. 6–8. Even though the Specification
indicates an inference engine may employ “off the shelf components” and
describes “Racer” as an example, the Specification does identify what
structure “Racer” connotes and does not describe the algorithmic or other
structure of the “off the shelf components” as specific structure or class of
structures. See Spec. 9:29–30. Rather, the Specification describes the
“inference engine IE” as a “generic component[ ] of a decision support
system.” Id. at 9:19–20. Accordingly, the Specification does not
sufficiently “connote a specific structure or a class of structures” for the term
“inference engine.” See MTD Prods. Inc. v. Iancu, 933 F.3d 1336 (Fed. Cir.
2019) (“That the specification discloses a structure corresponding to an
asserted means-plus-function claim term does not necessarily mean that the
claim term is understood by persons of ordinary skill in the art to connote a
specific structure or a class of structures.”).
The surrounding language in claim 1 further supports this
determination. The limitation at issue, “the inference engine (IE) is
configured to classify asserted facts in the knowledge base (KB) to
determine a correct position of a class of classes in a hierarchy using logical
definitions of the classes,” recites an “inference” that appears to include a
function of classifying facts “to determine a correct position of a class of
classes in a hierarchy using logical definitions of the classes.” But neither
the phrase nor the Specification connotes specific algorithmic or hardware
structure or such structure as a class.
Appellant does not address the Examiner’s contention regarding the
“interference engine.” See Appeal Br. 6 (addressing “decision support
mechanism” and “middleware section”). Appellant’s arguments regarding
Appeal 2019-000810
Application 12/441,184

8
the “decision support mechanism” and “middleware section” support, rather
than rebut, the Examiner’s contention. Specifically, Appellant’s arguments
show that the Specification describes the terms “decision support
mechanism” and “middleware section” in generic terms that cover a wide
variety of structures, including respectively “hardware and/or software” and
“hardware, firmware, or software, or a combination thereof”:
For example, the term “decision support mechanism
(DSM)” alone connotes the hardware and/or software used to
obtain a decision support system with a more comprehensive
approach with respect to the patient because patient data are
combined with input data (MDx) delivered from one or more
molecular diagnostics measurement devices, as would be
apparent to one of ordinary skill in the art. Appellants also note
that illustrative DSMs [sic] a Bayesian network, an artificial
neural network, a support vector machines mechanism, a K
nearest neighbor mechanism, a genetic algorithm mechanism, a
decision tree mechanism, a rule based system, a case based
reasoning mechanism, and a fuzzy logic based mechanism.
These mechanisms clearly can be instantiated in hardware and/or
software, as would be readily appreciated by one of ordinary skill
in the art, who had the benefit of the filed application. Similarly,
the term “a middleware section” alone connotes the hardware,
firmware, or software, or a combination thereof that
interconnects portions of the system of various embodiments.
For example, and as disclosed initially in paragraph [0015] of the
filed application, in a representative embodiment, the
middleware section interconnects the patient information
database (EMJ), the data input section (DAT), the clinical
guideline database (CL), the knowledge database (KB), the first
decision support mechanism (1DSM), and the second decision
support mechanism (2DSM).
Appeal Br. 6–7.4

4 We do not see, in this record, the Specification that Appellant references in
its citation to “paragraph [0015] of the filed application.” None of the three
Appeal 2019-000810
Application 12/441,184

9
Appellant correctly points out the terms need not “denote a specific
structure or a precise physical structure to avoid the application of . . . 35
U.S.C. 112, paragraph 6.” Appeal Br. 7. Also, “paragraph 6 will not apply
if persons of ordinary skill in the art reading the specification understand the
term to be the name for the structure that performs the function, even when
the term covers a broad class of structures or identifies the structures by their
function (e.g., ‘filters,’ ‘brakes,’ ‘clamp,’ ‘screwdriver,’ and ‘locks’).” Id.
(citing inter alia, MPEP § 2181(I)(A)).
Nevertheless, nothing in the functions recited or descriptions in the
Specification identify the structure or connote a broad class of structures. As
the Examiner reasons, “Appellant continues with generic descriptions of
functional items without describing how the functional items are created.”
Ans. 5.
Similarly, regarding the “middleware (MW) section interconnecting
the patient information database (EMJ), the data input section (DAT), the
clinical guideline database (CL), the knowledge database (KB), the first
decision support mechanism (1DSM), and the second decision support
mechanism (2DSM),” nothing in the recited interconnecting function
specifies how the devices will be interconnected. Moreover, the
Specification and Appellant’s arguments indicate the term connotes several
classes of structures, namely, hardware, software, a combination of the two,
wireless structure, electrical structure, and/or, in addition, something that

Specifications in the record include paragraph numbers. See supra note 2.
In any event, we agree with Appellant that the Specification describes a wide
variety of software and/or hardware as corresponding to “a middleware
section” and “decision support mechanism.”
Appeal 2019-000810
Application 12/441,184

10
“embeds” other components, and something that may or may not “control”
the communication. See Spec. 7:20–26 (“As such the other components
depicted in Fig. 1 may be considered to be embedded in the middleware
MW, but for practical considerations the middleware section 25 MW enables
the communication by electric/wireless connections and control this
communication.”) (emphasis added); Appeal Br. 6–7.
Similarly, regarding the “decision support mechanisms [for]
process[ing] input data (MDx) into patient related information (PRI) using
the patient information database (EMJ), the clinical guideline database (CL)
and the knowledge database (KB),” nothing in the recited process function
specifies how the “mechanisms” will “process” the input data (MDx) data
using the three other databases recited in claim 1 (and similarly recited in
claim 13). Nothing in the claim or the Specification indicates what the
“process” entails, or what form the resulting PRI data takes. Nothing shows
how the “hardware and/or software” implementing the various algorithms or
mechanisms that Appellant describes represents a class of “mechanisms”
that “process” data into PRI. See Appeal Br. 6–7 (“Appellant[] also note[s]
that illustrative DSMs [sic] a Bayesian network, an artificial neural network,
a support vector machines mechanism, a K nearest neighbor mechanism, a
genetic algorithm mechanism, a decision tree mechanism, a rule based
system, a case based reasoning mechanism, and a fuzzy logic based
mechanism.”).
As Appellant recognizes, “MPEP § 2181(I) . . . provide[s] some
examples of ‘nonce words’ or ‘generic placeholders’ for the term ‘means,’
including ‘mechanism for,’ ‘module for,’ ‘device for,’ ‘unit for,’ ‘component
for,’ ‘element for,’ ‘member for,’ ‘apparatus for,’ ‘machine for,’ or ‘system
Appeal 2019-000810
Application 12/441,184

11
for.’” Appeal Br. 8. Although Appellant contends these words are not
“similar to ‘interface’,” none of the terms at issue here involve the term
“interface.” See id. Rather, the terms involve the generic terms “inference
engine,” “decision support mechanism,” and “middleware (MW) section,” as
the Examiner recognizes.
Under MTD Products, 933 F.3d at 1338, the Board commits “err[or]
by conflating corresponding structure in the specification with a structural
definition for the term.” Id. (holding “‘mechanical control assembly’ is a
nonce term that is not used in common parlance and does not bring to mind
any specific structure to a person of ordinary skill in the art”). Here, as
discussed above, and as Appellant argues, the Specification discloses myriad
generic structures that embrace all manner of structures capable of
performing the functions of the terms “inference engine,” “decision support
mechanism,” and “middleware (MW) section,” as recited in claim 1. See
MTD Prods., 933 F.3d at 1342 (“Instead, the extrinsic evidence
demonstrated only that ‘a skilled artisan would understand the functional
term cheque standby unit to be any structure capable of performing the
claimed function.’” (quoting Diebold Nixdorf, Inc. v. Int’l Trade Comm’n,
899 F.3d 1291, 1300 (Fed. Cir. 2018) (internal quotation marks omitted)
(emphasis added)).
MTD Products reiterates that “[g]eneric terms like ‘module,’
‘mechanism,’ ‘element,’ and ‘device’ are commonly used as verbal
constructs that operate, like ‘means,’ to claim a particular function rather
than describe a ‘sufficiently definite structure.’” Id. at 1341 (citing
Williamson v. Citrix Online, LLC, 792 F.3d 1339, 1350 (Fed. Cir. 2015) (en
banc)). Directly contrary to Appellant’s argument that “the presumption is a
Appeal 2019-000810
Application 12/441,184

12
strong one that is not readily overcome,” Appeal Br. 6 (emphasis added),
Williamson holds “such a heightened burden is unjustified and that we
should abandon characterizing as ‘strong’ the presumption that a limitation
lacking the word ‘means’ is not subject to § 112, para. 6.” Williamson, 792
F.3d at 1349 (emphasis added).
As MTD Products directs, “we apply a rebuttable presumption that the
term conveys sufficiently definite structure and is not subject to § 112, ¶ 6.”
MTD Prods., 933 F.3d at 1342 (citing Williamson, 792 F.3d at 1348). “A
challenger can rebut the presumption by demonstrating ‘that the claim term
fails to recite sufficiently definite structure or else recites function without
reciting sufficient structure for performing that function.’” Id. (quoting
Williamson, 792 F.3d at 1348 (internal quotations omitted)). Based on the
foregoing discussion, the Examiner rebuts the Williamson presumption and
shows the claim terms recite generic (nonce) words that do not connote
sufficiently definite structure.
Accordingly, Appellant does not show error in the Examiner’s
construction of the three claim 1 limitations, “decision support mechanism,”
“interference engine,” and “middleware section,” as nonce words
substituting for “means for” terms that fall under 35 U.S.C. § 112, sixth
paragraph.
B. Indefiniteness
The Examiner rejects claims 1–12 under 35 U.S.C. § 112, second
paragraph, as being indefinite, because the Specification does not disclose
the algorithmic structure for the means plus function terms noted above in
Section V.A, namely the “middleware (MW) section,” the “inference
Appeal 2019-000810
Application 12/441,184

13
engine,” and the “decision support mechanisms.” Final Act. 9. The three
claim 1 terms at issue follow:
a middleware (MW) section interconnecting the patient
information database (EMJ), the data input section (DAT), the
clinical guideline database (CL), the knowledge database (KB),
the first decision support mechanism (1DSM), and the second
decision support mechanism (2DSM),
wherein the inference engine (IE) is configured to classify
asserted facts in the knowledge base (KB) to determine a correct
position of a class of classes in a hierarchy using logical
definitions of the classes,
wherein the first (1DSM) and the second (2DSM) decision
support mechanisms process input data (MDx) into patient
related information (PRI) using the patient information database
(EMJ), the clinical guideline database (CL) and the knowledge
database (KB).
As the Examiner determines, the Specification does not describe the
structure corresponding to the three means-plus-function terms at issue here.
See Final Act. 9.
Figure 1 of the Specification follows:

Appeal 2019-000810
Application 12/441,184

14
Figure 1 above depicts first and second decision support mechanisms 104
and 106 for processing input data MDx, with clinical guideline database CL
102 and knowledge database KB 108, all included with or interconnected via
middleware section 110. Spec. 7:1–26, 8:1–6.
Appellant argues claims 1–13 as a group, notwithstanding that the
Examiner did not reject claim 13 for indefiniteness. Appeal Br. 9–10.
Accordingly, claim 1 represents the claims rejected for indefiniteness.
Appellant argues that the Specification describes a wide variety of
structure for the “decision support mechanism” and “middleware section.”
Appeal Br. 9. For example, Appellant describes at least nine generic
algorithms that connote structure for the “decision support mechanism,”
maintaining “[t]hese mechanisms clearly can be instantiated in hardware
and/or software”:
illustrative DSMs include a Bayesian network, an artificial
neural network, a support vector machines mechanism, a K
nearest neighbor mechanism, a genetic algorithm mechanism, a
decision tree mechanism, a rule based system, a case based
reasoning mechanism, and a fuzzy logic based mechanism.
These mechanisms clearly can be instantiated in hardware and/or
software, as would be readily appreciated by one of ordinary skill
in the art, who had the benefit of the filed application.

Id. at 9–10. These arguments that describe generic algorithms, without
more, support the Examiner’s determination, because they essentially serve
to capture every possible type of structure for the “decision support
mechanisms,” contrary to the requirements of 35 U.S.C. § 112, sixth
paragraph.
The “decision support mechanisms” in claim 1 “process[es] input data
(MDx) into patient related information (PRI) using the patient information
Appeal 2019-000810
Application 12/441,184

15
database (EMJ), the clinical guideline database (CL) and the knowledge
database (KB).” According to the Specification, “[t]he elements and
components of an embodiment of the invention may be physically,
functionally and logically implemented in any suitable way.” Id. at 8:16–18.
According further to the Specification, “[t]he decision support system may
then have several applications (e.g. diseases or users), each with different
rules/procedures defining the operation of the middleware. The decision
support system can thereby be very adaptive.” Id. at 4:7–10. The
Specification does not specify the “rules/procedures,” or sufficient
algorithmic or other structure for how “decision support mechanisms process
input data . . . into patient related information (PRI) using” the recited
databases, as claim 1 recites. The Specification does not describe what the
“process” entails, including how the process creates the PRI, and how it uses
the databases to create the PRI. As the Examiner finds, the Specification
does not sufficiently disclose the algorithmic structure to achieve the
claimed process involved in the decision support mechanisms. Final Act. 8–
9.
Regarding “middleware section” 110, Appellant argues “in a
representative embodiment, the middleware section interconnects the patient
information database (EMJ), the data input section (DAT), the clinical
guideline database (CL), the knowledge database (KB), the first decision
support mechanism (1DSM), and the second decision support mechanism
(2DSM).” Appeal Br. 10. However, Appellant contends “that the term ‘a
middleware section’ alone connotes the hardware, firmware, or software, or
a combination thereof that interconnects portions of the system of various
Appeal 2019-000810
Application 12/441,184

16
embodiments.” Id. These arguments fail to show how the Specification
discloses the corresponding algorithmic or hardware structure.
The Specification states “[t]he middleware MW section 110
interconnects the patient information database EMJ, the data input section
DAT, the clinical guideline database CL, the knowledge database KB, the
first decision support mechanism 1DSM, and the second decision support
mechanism 2DSM.” Spec. 7:20–23. It also states “other components
depicted in Fig. 1 may be considered to be embedded in the middleware
MW, but for practical considerations the middleware section MW enables
the communication by electric/wireless connections and control this
communication.” Id. at 7:23–26 (emphasis added). Nothing indicates how
the middleware embeds components, or how it “enables the electric/wireless
connections and control[s] this communication.” Nothing shows how the
middleware section interconnects the seven claimed components, including
three databases, two decision support mechanisms, and a data input section.
Another section of the Specification describes the following: “In one
embodiment, the middleware section (MW) may comprise an application
sub-section (APP), wherein an application is selectable, each application
having one or more corresponding rules related to that application of the
system.” Spec. 4:5–10. The Specification does not describe the rules or the
application.
The Specification further describes generic functionality for the
middleware section, as “computer software,” or otherwise “physically,
functionally and logically implemented in any suitable way,” “including any
kind of connection including, but not limited to, electrical connections and
wireless connections”:
Appeal 2019-000810
Application 12/441,184

17
The invention as illustrated in Fig. 1 can be implemented in any
suitable form including hardware, software, firmware or any
combination of these. The invention or some features of the
invention can be implemented as computer software running on
one or more data processors and/or digital signal processors. The
elements and components of an embodiment of the invention
may be physically, functionally and logically implemented in
any suitable way. Indeed, the functionality may be implemented
in a single unit, in a plurality of units or as part of other functional
units. As such, the invention may be implemented in a single
unit, or may be physically and functionally distributed between
different units and processors. The middleware section MW
interconnecting the elements of the DSS can include any kind of
connection including, but not limited to, electrical connections
and wireless connections.
Spec. 8:13–23 (emphases added). As the Examiner finds, the Specification
does not sufficiently disclose the algorithmic or hardware structure to
achieve the claimed function of interconnecting by the middleware section,
because the interconnecting function embraces every conceivable type of
interconnection scheme, including some that may or may not control the
data flow, and may or may not embed various interconnected components.
Appellant does not present argument with respect to the inference
engine. See Appeal Br. 9–10. In any event, similar remarks apply to
“wherein the inference engine (IE) is configured to classify asserted facts in
the knowledge base (KB) to determine a correct position of a class of classes
in a hierarchy using logical definitions of the classes,” as claim 1 recites.
Nothing in the Specification reveals how the inference engine classifies
facts, what facts it classifies, how it uses “a hierarchy using logical
definitions of the classes,” and what “logical definitions” or “classes” it uses.
As noted above, “[t]he guideline execution engine CL-EE and inference
engine IE are generic components of a decision support system and have no
Appeal 2019-000810
Application 12/441,184

18
specific requirements for a molecular diagnosis application.” Spec. 9:19–21.
They may include “available off the shelf components.” Id. at 9:28–29.
Nevertheless, the Specification indicates this classification scheme
does not involve basic functions of a microprocessor, and it does not clarify
whether or not the off the shelf components require further special
programming, or whether they connote a class of structure. In other words,
as the Examiner finds, the Specification does not specify an algorithm or a
sufficiently clear algorithm clearly linked to the functions of the inference
engine. “A microprocessor or general purpose computer lends sufficient
structure only to basic functions of a microprocessor. All other computer
implemented functions require disclosure of an algorithm.” EON Corp. IP
Holdings LLC v. AT&T Mobility LLC, 785 F.3d 616 (Fed. Cir. 2015). (“As
we stated in Katz, a microprocessor can serve as a structure for a computer-
implemented function only where the claimed function is ‘coextensive’ with
a microprocessor itself. . . . Examples of such coextensive functions are
‘receiving’ data, ‘storing’ data, and ‘processing’ data.”) (citing In re Katz,
639 F.3d 1303, 1316 (Fed. Cir. 2015)); Noah Sys., Inc., v. Intuit Inc., 675
F.3d 1302, 1316–17 & n.9 (Fed. Cir. 2012) (indicating “off-the-shelf
accounting software” cannot fill the gaps for algorithmic structure required
in processor claims).5 As the Examiner finds, the Specification does not

5 EON and Noah do not foreclose or address squarely the situation in which
a patent discloses and identifies corresponding structure as known, or “off
the shelf,” hardware and/or software clearly linked to a claimed function at
issue. In Atmel Corp. v. Information Storage Devices, Inc., 198 F.3d 1374,
1381 (Fed. Cir. 1999), the patentee claimed an apparatus that included a
“high voltage generating means” limitation, thereby invoking 35 U.S.C.
§ 112 ¶ 6. The specification incorporated by reference a non-patent
document from a technical journal, which described a particular high voltage
Appeal 2019-000810
Application 12/441,184

19
sufficiently disclose the algorithmic structure to achieve the claimed
function of classifying asserted facts by the inference engine.
Based on the foregoing discussion, Appellant does not show error in
the Examiner’s rejection of claims 1–12 for indefiniteness under 35 U.S.C.
§ 112, second paragraph.
C. Written Description
The Examiner rejects claims 1–13 under 35 U.S.C. § 112, first
paragraph, for failing to comply with the written description requirement.
Final Act. 7–8. According to the Examiner, “the claim(s) contains
subject matter which was not described in the specification in such a way as
to reasonably convey to one skilled in the relevant art that the inventor . . .
had possession of the” “process” and “processing” features of the decision
support mechanisms as respectfully recited in claims 1 and 13. See Final
Act. 7–8.
The Examiner quotes the Specification, inter alia, as stating “[a]
formal definition of what constitutes a decision support mechanism (DSM)
can be very difficult to formulate.” Final Act. 8 (quoting Spec. 9:1–2). The
Examiner quotes portions of the Specification that describe several examples
of such mechanisms, including
a Bayesian network, an artificial neural network, a support vector
machines mechanism, a K nearest neighbor mechanism, a

generating circuit. The Federal Circuit concluded that the title of the article
in the specification may, by itself, be sufficient to indicate to one skilled in
the art the precise structure of the means for performing the recited function,
and it remanded the case to the district court “to consider the knowledge of
one skilled in the art that indicated, based on unrefuted testimony, that the
specification disclosed sufficient structure corresponding to the high-voltage
means limitation.” Id. at 1382.
Appeal 2019-000810
Application 12/441,184

20
genetic algorithm mechanism, a decision tree mechanism, a rule
based system, a case based reasoning mechanism, and a fuzzy
logic based mechanism. Thus, the first (IDSM) and/or the
second (2DSM) decision support mechanism may be chosen
from such a group of decision support mechanisms.
Id. (quoting Spec. 3:25–32).
The Examiner also points to a portion of the Specification that refers
to “open boxes” for the two support mechanisms, describing the two as
“interact[ing] tightly from within the mechanism.”
The Examiner quotes the following related coupling teachings and
generic algorithms/logic involved with the two support mechanisms:
One example is to use inferences from the Knowledge
Base KB to drive the crossover and mutations in a Genetic
Algorithm (GA). This tight coupling will introduce biological
knowledge to guide the purely statistical process in the Genetic
Algorithm GA. Thus, the genes in the GA are not treated as
anonymous independent entities, but rather as ones with
significance and interrelationships. Another example is to use a
Bayesian - or a Fuzzy logic based network to resolve a criterion
in a decision step in a clinical guideline CL. This requires the
Bayesian/Fuzzy network to access the patient state in the
guideline.
Final Act. 9 (quoting Spec. 9:1–13).
Appellant groups claims 1 and 13 together, and does not present
separate arguments for the dependent claims. See Appeal Br. 19–21.
Accordingly, claim 1 represents the claims rejected for written description.
Appellant contends “the claims do not recite an algorithm for
processing input data. Thus, [the S]pecification needs not provide a written
description of an algorithm for processing input data.” Appeal Br. 20.
Appellant’s argument does not squarely address the Examiner’s point.
The Specification describes a wide variety of decision making processes in
Appeal 2019-000810
Application 12/441,184

21
functional and generic terms, but does not describe what the “process” and
“processing” features of the decision support mechanisms entail, including
the extent of the claimed “operably coupled” and “interacting” features
involved in the “processing,” in light of the “tight coupling” disclosed.
The Examiner recognizes that a lack of disclosure of algorithmic
structure that otherwise would serve to provide written descriptive support
and circumscribe the “process” and “processing” of claims 1 and 13, shows
that the inventors did not have possession of the invention. In particular
claim 1, similar to claim 13, specifies that the first and second support
mechanisms “process” the input data “using” three databases and “are
operably coupled so as to interact during the processing of” the input data:
wherein the first (1DSM) and the second (2DSM) decision
support mechanisms process input data (MDx) into patient
related information (PRI) using the patient information database
(EMJ), the clinical guideline database (CL) and the knowledge
database (KB), and
wherein the first (1DSM) and the second (2DSM) decision
support mechanism are operably coupled through the
middleware (MW) so as to interact during the processing of the
input data (MDx).
Appeal Br. 28 (App’x (emphasis added to claim 1 limitations)).
The absence of clearly linked algorithmic structure leaves an artisan
of ordinary skill wondering as to the amount and type of processing and
interacting that occurs to create the PRI, including the type of data the
process “use[es]” from the three databases, and the type of process the
support mechanisms perform on the input data and any data within the three
recited databases the support mechanisms “us[e].” The Specification also
does not describe sufficiently the amount and type of “coupling” and
“interact[ing]” between the two decision support mechanisms “during the
Appeal 2019-000810
Application 12/441,184

22
processing” of the input data to create the PRI, and it mentions highly
generic algorithms without any specificity, for example using “a Bayesian -
or a Fuzzy logic based network,” and/or a “Genetic Algorithm (GA).” See
Spec. 9:1–13.6
This lack of description of the process involved in creating the PRI
shows the inventors lacked possession of the process of the decision support
mechanisms as recited in claims 1 and 13 that create the PRI. Essentially,
the inventors seek to claim every possible manner in functional and generic
terms, including any type of decision process and interaction between the
two support mechanisms, to process data creating the PRI, without
describing structural features common to all the types of processes disclosed,
as necessary to show possession of the whole breadth of the “process” or
“processing.” In other words, the Specification fails to disclose “a
representative number of species falling within the scope of the genus or
structural features common to the members of the genus so that one of skill
in the art can ‘visualize or recognize’ the members of the genus.” Ariad
Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en

6 The Specification introduces other levels of speculation in the decision
support mechanisms, further indicating a lack of possession of the claimed
process involved in the decision support mechanisms:
It has to be decided what recommendations the decision support
system MD DSS needs to produce, and work backwards to
establish what data must be collected in order to support the
production of these recommendations, and further backwards to
identify where the relevant data come from and how they will be
captured and normalized, see S. Coady, Influencing 25 physician
practice variation, in Health Management Technology, 2002.
Spec. 11:20–25 (emphasis added).
Appeal 2019-000810
Application 12/441,184

23
banc) (quoting Regents of the Univ. of California v. Eli Lilly & Co., 119
F.3d 1559, 1568–69 (Fed. Cir. 1997) (emphasis added).
Ariad explains further,
[a]s this court has repeatedly stated, the purpose of the
written description requirement is to “ensure that the scope of the
right to exclude, as set forth in the claims, does not overreach the
scope of the inventor’s contribution to the field of art as
described in the patent specification.” Rochester, 358 F.3d at
920 (quoting Reiffin v. Microsoft Corp., 214 F.3d 1342, 1345
(Fed.Cir.2000)). It is part of the quid pro quo of the patent grant
and ensures that the public receives a meaningful disclosure in
exchange for being excluded from practicing an invention for a
period of time. Enzo, 323 F.3d at 970.
Id. at 1353–54 (citing Univ. of Rochester v. G.D. Searle & Co., Inc., 375
F.3d 1303 (Fed. Cir. 2004); Enzo Biochem, Inc. v. Gen–Probe Inc., 323 F.3d
956, 970 (Fed. Cir. 2002)).
Appellant’s arguments show a lack of a meaningful contribution
disclosed relative to claim scope in violation of the quid pro quo enunciated
by Ariad. For example, Appellant agrees that the breadth of the claims
encompasses all manner of structure, reciting, inter alia, the following
portion of the Specification in an effort to rebut the Examiner’s written
description rejection:
FIG. 1 can be implemented in any suitable form including
hardware, software, firmware or any combination of these. The
invention or some features of the invention can be implemented
as computer software running on one or more data processors
and/or digital signal processors. The elements and components
of an embodiment of the invention may be physically,
functionally and 1ogically implemented in any suitable way.
Indeed, the functionality may be implemented in a single unit, in
a plurality of units or as part of other functional units. As such,
the invention may be implemented in a single unit, or may be
Appeal 2019-000810
Application 12/441,184

24
physically and functionally distributed between different units
and processors.
Appeal Br. 21 (quoting Spec. 8:13–21) (emphases added).
This quotation of the Specification by Appellant shows a lack of
commonality as to structure, because it refers to “hardware, software,
firmware or any combination of these” and describes the invention as
capable of being “physically, functionally and 1ogically implemented in any
suitable way.” See Spec. 8:13–21. Appellant provides quotations of similar
bearing from the Specification describing operations illustrated with respect
to Figures 2 and 3, some of which we discuss above. See Appeal Br. 22–23.
These Specification portions show the inventors seek to capture all manner
of processing data to create the PRI. None of the citations show the
inventors had possession of the full scope of the claimed process of the
decision support mechanisms in claims 1 and 13 that create the PRI. See
Appeal Br. 21–23. The Specification does not describe the amount and type
of interaction between, or the amount and type of process implemented by,
the recited decision support mechanisms, to create the PRI, and accordingly,
what the PRI entails. In short, the Specification attempts to embrace, in
generic terms, any type of process existing at the time of the invention to
create any type of PRI, failing to provide adequate disclosure to show the
inventors had possession of the full scope of claims 1 and 13. Lacking “a
meaningful disclosure,” Ariad Pharm., Inc., 598 F.3d at 1354, claims 1 and
13 “overreach the scope of the inventor’s contribution to the field of art as
described in the patent specification,” id. at 1354 (quoting Rochester, 358
F.3d at 920).7

7 The written description problem stems from a lack of a disclosure of the
Appeal 2019-000810
Application 12/441,184

25
Accordingly, Appellant does not show that the Examiner erred in rejecting
claims 1–13 under 35 U.S.C. § 112, first paragraph, for lack of a written
description.
D. Non-Statutory Subject Matter
A patent-eligible invention must claim a “new and useful process,
machine, manufacture, or composition of matter.” 35 U.S.C. § 101.
However, the Supreme Court, in a long line of precedent, interprets 35
U.S.C. § 101 to include implicit exceptions to statutory subject matter:
“[l]aws of nature, natural phenomena, and abstract ideas.” See, 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, the
Supreme Court’s two-step framework, described in Mayo and Alice, frames
the analysis. Id. at 217–18 (citing Mayo Collaborative Servs. v. Prometheus
Labs., Inc., 566 U.S. 66, 75–77 (2012)). In accordance with that framework,
a tribunal first determines 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

algorithmic structure corresponding to the decision support mechanisms’
process functionality, as the Examiner recognizes and as indicated above.
See Final Act. 7–8. “Sufficient structure must simply ‘permit one of
ordinary skill in the art to know and understand what structure corresponds
to the means limitation’ so that he may ‘perceive the bounds of the
invention.’” See In re Aoyama, 656 F.3d 1293, 1298 (Fed. Cir. 2011); cf.
EnOcean, GmbH v. Face Int’l Corp., 742 F.3d 955, 959 (Fed. Cir. 2014)
(quoting Aoyama, 656 F.3d at 1298, in determining if a priority document
provided written description support for the term “receiver,” concluding
“receiver” is not a means plus function limitation, so “[i]n requiring that the
German and PCT applications ‘expressly describe the structure of the
receiver,’ the Board applied an incorrect standard” (quoting the underlying
Board decision)).
Appeal 2019-000810
Application 12/441,184

26
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 systems for, or 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, 69
(1972)).
If the claim is “directed to” an abstract idea, the second step of the
Alice and Mayo framework requires “examin[ing] 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.
(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.
The PTO recently published revised guidance on the application of
§ 101. USPTO’s January 7, 2019 Memorandum, 2019 Revised Patent
Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (“Guidance”). Under
Step 2A of the Guidance, PTO judges and examiners must determine if the
claims recite any judicial exceptions, i.e., a law of nature, a natural
phenomenon, or an abstract idea (mathematical concepts, certain methods of
Appeal 2019-000810
Application 12/441,184

27
organizing human activity such as a fundamental economic practice, or
mental processes) (Prong 1); and additional elements in the claim as a whole
that integrate the judicial exception into a practical application (see MPEP
§ 2106.05(a)–(c), (e)–(h)) (Prong 2). Id. at 52–54.
Furthermore, under Prong 1, the Guidance “extracts and synthesizes
key concepts identified by the courts as abstract ideas to explain that the
abstract idea exception includes the following groupings of subject matter,
when recited as such in a claim limitation(s) (that is, when recited on their
own or per se)”:
(a) Mathematical concepts—mathematical relationships,
mathematical formulas or equations, mathematical calculations;
(b) Certain methods of organizing human activity—
fundamental economic principles or practices (including
hedging, insurance, mitigating risk); commercial or legal
interactions (including agreements in the form of contracts; legal
obligations; advertising, marketing or sales activities or
behaviors; business relations); managing personal behavior or
relationships or interactions between people (including social
activities, teaching, and following rules or instructions); and
(c) Mental processes—concepts performed in the human
mind (including an observation, evaluation, judgment, opinion).
Id. at 52 (footnotes omitted).
Under Step 2B, only if the claim recites a judicial exception and does
not recite additional elements that integrate the judicial exception into a
practical idea, then PTO examiners and judges investigate whether the
claim
[a]dds a specific limitation or combination of limitations
that are not well-understood, routine, conventional activity in the
field, which is indicative that an inventive concept may be
present; or
simply appends well-understood routine, conventional
activities previously known to the industry, specified at a high
Appeal 2019-000810
Application 12/441,184

28
level of generality, to the judicial exception, which is indicative
that an inventive concept may not be present.
Id. at 56 (bullet points omitted).
Guidance, Step 2A, Prong 1
The Examiner refers to the “interconnecting,” “classify,” and
“process” steps in claim 1 as gathering and processing different types of
data, namely, the following steps of claim 1: “a middleware (MW) section
interconnecting the patient information database (EMJ), the data input
section (DAT), the clinical guideline database (CL), the knowledge database
(KB), the first decision support mechanism (1DSM), and the second
decision support mechanism (2DSM),” “wherein the inference engine (IE)
is configured to classify asserted facts in the knowledge base (KB) to
determine a correct position of a class of classes in a hierarchy using logical
definitions of the classes,” and “wherein the first (1DSM) and the second
(2DSM) decision support mechanisms process input data (MDx) into patient
related information (PRI) using the patient information database (EMJ), the
clinical guideline database (CL) and the knowledge database (KB).” See
Final Act. 5–6 (emphasis added).
According to the Examiner,
[t]hese steps describe the concept of receiving data, processing
data, and outputting the results, which corresponds to concepts
identified as abstract ideas by the courts, such as collecting,
displaying, and manipulating data in Int. Ventures v. Cap One
Financial, and collecting information, analyzing it, and
displaying certain results of the collection and analysis in Elect[.]
Power. . . . All of these concepts relate to abstract ideas in and
of themselves. The concept described in claim 1 is not
meaningfully different than those concepts found by the courts
to be abstract ideas. As such, the description in claims 1 and 13
Appeal 2019-000810
Application 12/441,184

29
of assisting clinician, a technician or a patient during the various
phases of molecular diagnostics is an abstract idea.
Id. at 5–6 (citing Elec. Power Group, LLC v. Alstom S.A., 830 F.3d 1350
(Fed. Cir. 2016) (“Electric Power”); Intellectual Ventures I LLC v. Capital
One Financial Corp., 850 F.3d 1332 (Fed. Cir. 2017) (“Capital One”)).
By applying the above-noted claim recitations as analogous to the
claims involved in Electric Power and Capital One, and characterizing the
claims as a whole as involving “various phases of molecular diagnosis,” the
Examiner shows the claims recite system limitations that include certain
methods for organizing human activity, namely following rules or
instructions for the collection and creation of the PRI data for teaching, and
the mental processes of assisting in the “molecular diagnostics,” both of
which constitute abstract ideas per the Guidance. See Guidance, 84 Fed.
Reg. at 52.
Specifically, although the “interconnecting” of different types of data
amounts to a physical connection of hardware or software components,
underlying that connection includes the mental evaluation by a human to
determine the types of data to “interconnect” in order to provide “patient
related information” (“PRI”), according to claim 1. Similarly, the step to
“classify” “facts” and “to determine a correct position of a class of classes in
a hierarchy using logical definitions of the classes,” as recited in claim 1,
involves using a “logical” human evaluation mental process “to determine a
correct position” in a classification hierarchy and involves following rules or
instructions, namely “a hierarchy using logical definitions.” Similarly, the
step “to process input data (MDx) into patient related information (PRI)
using” different types of data, including data in “the patient information
database (EMJ), the clinical guideline database (CL) and the knowledge
Appeal 2019-000810
Application 12/441,184

30
database (KB),” recites a human mental evaluation and judgment process a
clinician performs on relevant medical data.
In addition, by reciting “for providing patient related information
(PRI)” in the preamble of claim 1, the system includes organizing human
activity, following certain rules or instructions of the claimed system to
process the data discussed above into PRI, and then “providing” the PRI to
teach the patient how to manage her behavior following instructions implicit
in the PRI. In other words, in addition to reciting mental processes, the
claims recite another abstract idea under the Guidelines, namely certain
methods of organizing human activity. Although claim 1 does not recite or
require explicitly an output, a prognosis, or a diagnosis, in addition to
reciting a step of organizing human activity, “providing” “PRI” also
amounts to a mental process of announcing or presenting the PRI to teach a
clinician about the data.8 See Spec. 8:7–8 (“A user interface, e.g. a screen or
a similar device, for presenting the patient related information PRI should be
used.”). Nevertheless, the above-noted claim limitations as a group recite a
system of organizing human activity, managing behavior by following rules
or instructions to process the data to create the PRI, and then presenting the
teachings in the PRI to a patient, so that the patient can alter her regimen or
behavior in order to overcome her illness according to teachings in the PRI.
Appellant groups independent claim 1 together with independent
claim 13, and does not argue any of the dependent claims separately. See
Appeal Br. 10–19. Accordingly, claim 1 represents the claims on appeal

8 See FairWarning IP, LLC v. Iatric Systems, Inc., 839 F.3d 1089 (Fed. Cir.
2016) (“[announcement] does nothing significant to differentiate a process
from ordinary mental processes”) (full quotation provided below).
Appeal 2019-000810
Application 12/441,184

31
under this § 101 rejection. Appellant initially contends the Examiner merely
sets forth “a conclusion regarding the alleged non-statutory subject matter of
claims 1 and 13.” Id. at 11. Contrary to this argument, however, as
discussed above, the Examiner analogizes claims held by Electric Power and
Capital One to recite non-statutory subject matter to claim 1 at issue here by
referring to specific steps recited therein. Moreover, Appellant recognizes
the Examiner’s analogy to Electric Power as alleging a “human mental
process,” id. at 14, but “disagree[s]” with that analogy, as follows:
Appellant[] disagree[s] with the Final Office Action's
assertion that claims 1–13 are analogous to Electric Power
Group, LLC v. Alstom S.A., 830 F.3d 1350 (Fed. Cir. 2016). In
that case, the Federal Circuit finds that the subject patents
describe and claim systems and methods for real-time
performance monitoring of an electric power grid by collecting
data from multiple data sources, analyzing the data, and
displaying the results, or stated differently, collecting, analyzing
and displaying available information in a particular field.
Id. at 13.
According to Appellant, “the claims of the present Application do not
merely collect and analyze data, and display the results. Nor is the
information available in the field, but rather provides a molecular
diagnostics decision support system (MD-DSS) for providing patient related
information as information is acquired.” Id.
Rather, according to Appellant,
unlike the data of the present claims, the data in Electric Power
. . . were stored data that could be collected and analyzed by
human mental process. Plainly, the generation, by the IE by the
classification of asserted facts in the knowledge base KB to find
the correct position of a class in a hierarchy using the logical
definition of the classes certainly cannot be effected mentally.
Appeal 2019-000810
Application 12/441,184

32
Id. at 14 (emphases added). Appellant also contends the claims are not
directed to “conventional handling of conventional information.” Id.
Appellant explains “conventional handling of preexisting data has been held
problematic, whereas introduction of ‘new’ data not known until the claim
processing is embraced as not being abstract.” Id.
Appellant’s arguments do not show error in the Examiner’s
determination that claim 1 recites an abstract idea. Appellant merely
provides a conclusion without explaining why the data recited in claim 1
normally processed and used by a clinician could not be processed mentally
by a clinician.
Specifically, Appellant fails to explain the basis for its assertion that
“the classification of asserted facts in the knowledge base KB to find the
correct position of a class in a hierarchy using the logical definition of the
classes certainly cannot be effected mentally.” See Appeal Br. 14 (emphasis
added). Humans have been classifying data in a hierarchy through
observation, evaluation, and judgment for a long time. Appellant admits that
“a limited number of trained technicians . . . are capable of performing
complex assays.” Id. at 16.9 As noted above, in general, the Specification,

9 We recognize “the gene expression, as input data (MDx), from the
molecular diagnostic measurement device,” as recited in claim 1, involves
machine created data, but Appellant appears to acknowledge trained
technicians can analyze even that data. See also Spec. 1:11–12 (“Decision
support systems for aiding with molecular diagnostics (MD) are currently
applied for analyzing the values found in a molecular diagnostic assay. . . .
Such decision support systems are quite helpful for the clinician’s
interpretation of values found in the molecular diagnostics when considering
the amount and/or complexity of such MD data.”).

Appeal 2019-000810
Application 12/441,184

33
tracking claim 1, reveals that “the invention provides information PRI that
can assist a physician, a clinician, and/or a technician in reaching a
diagnosis.” Spec. 8:10–12 (emphasis added). Humans have provided
general information to create specific information, to assist in mentally
understanding the information, or to make decisions, including medical
decisions, for a long time.
As Appellant recognizes, recent precedent, including Electric Power
cited by the Examiner, shows that under certain circumstances, processing
and manipulating data may be abstract as a mental process, notwithstanding
that a computer also processes the data. As an example, FairWarning IP,
LLC v. Iatric Systems, Inc., 839 F.3d 1089 (Fed. Cir. 2016), citing Electric
Power, characterizes certain data gathering recitations as involving an
abstract mental process:
As we have explained, “merely selecting information, by content
or source, for collection, analysis, and [announcement] does
nothing significant to differentiate a process from ordinary
mental processes, whose implicit exclusion from § 101
undergirds the information-based category of abstract ideas.”
FairWarning, 839 F.3d at 1097 (quoting Elec. Power, 830 F.3d at 1355)
(emphasis added) (information added by FairWarning).
As another example, according to Data Engine Technologies LLC v.
Google LLC, 906 F.3d 999, 1010 (Fed. Cir. 2018), “[t]he invention
[involved in Capital One] allowed users to make changes to data in a
‘dynamic document,’ which could then be dynamically propagated back into
an original XML document.” Id. (quoting Capital One, 850 F.3d at 1339).
The Data Engine court characterized the Capital One holding as follows:
“We held those claims were ‘directed to the abstract idea of collecting,
displaying, and manipulating data.’” Id. (quoting Capital One, 850 F.3d at
Appeal 2019-000810
Application 12/441,184

34
1339). Appellant recognizes, without providing a meaningful distinction
over the recitations relied upon in claim 1 here, that Electric Power involves
claims directed to “real-time performance monitoring” of data––claims the
court in that case held recited a mental process, and hence an abstract idea.
See Appeal Br. 13–14.
Essentially, the invention seeks to automate a mental process of
classifying certain facts, and processing and combining different types of
informational data to create other information, namely, PRI, without
requiring a diagnosis. The record shows that claim 1 recites limitations
directed to, and claim 1 focuses on, a mental process to create and present
PRI, and also, organizing human activity including managing personal
behavior by following rules to obtain PRI and teaching a patient or a
clinician via PRI.
As noted above, Appellant groups claims 1–13 together. Based on the
foregoing discussion, the Examiner shows that claims 1–13, individually and
as a whole, recite the abstract ideas of mental processes and a system of
organizing human activity.
Guidance, Step 2A, Prong 2
In determining whether the claims are “directed to” the identified
abstract idea, we consider here whether the claims recite “additional
elements” that integrate the judicial exception into a practical application.
See Guidance, 84 Fed. Reg. at 54–55.10 The Examiner finds that the

10 Some of the considerations at Step 2A, second prong, properly may be
evaluated under Step 2 of Alice (Step 2B of the Office guidance). See
Memorandum, 84 Fed. Reg. at 55 n.25, 27–32.

Appeal 2019-000810
Application 12/441,184

35
“generic components” recited in the claims, “considered both individually
and as an ordered combination,” fail to integrate the judicial exception into a
practical application. See Final Act. 7.
Appellant argues “various elements in the claims are sufficient to
ensure that the claims amount to significantly more than the abstract idea
itself, particularly in that the claim as a whole is for a particular application
of the asserted abstract idea.” Appeal Br. 15. Appellant relies on recited
software components that claim 1 does not require or that merely implement
mental processes or limitations involved in organizing human activity, by
using generic computer components, as follows:
For example, claim 1 introduces the concept of a guideline
execution engine CL-EE. The guideline execution engine CL-
EE is a software component that can step through the executable
guideline and suggest one or more steps in the guideline based
on patient status. The GUF3 Guideline Execution Engine
(GLEE) is an example of such engine. Claim 1 also introduces
the concept of an inference engine (IE) that is configured to
classify asserted facts in the knowledge base (KB) to determine
a correct position of a class of classes in a hierarchy using logical
definitions of the classes. The inference engine IE will classify
the asserted facts in the knowledge base KB to find the correct
position of a class in a hierarchy using the logical definition of
the classes. This will enable an application section to learn about
the inferred relationships among the facts. With respect to
guidelines CL, it can be said that some guidelines aim to
overcome the problem of having a limited number of trained
technicians who are capable of performing complex assays.
Other guidelines aim to identify the necessary education and
counseling that must be made available to patients. For example
the Huntington's disease Society of America provides a series of
guides aimed at educating and counseling patients and their
families. (See pp. 9–10 of the filed application.) As such, by the
present teachings the system overcomes at least a shortage in
train technicians.
Appeal 2019-000810
Application 12/441,184

36
Appeal Br. 15–16 (emphases omitted and added).
First, no claim recites a guideline execution engine. Second, as
argued above, Appellant fails even to assert that the inference engine
software does anything more than what a human performs mentally. Third,
even if the claims require both the guideline and inference engines,
Appellant admits that “a limited number of trained technicians . . . are
capable of performing complex assays.” See id. at 16. Appellant also
admits “by the present teachings[,] the system overcomes at least a shortage
in train technicians,” id., thereby showing the system merely automates
mental processes or organizes human activity using a computer as a tool.
Nothing in the Specification cited by Appellant and required by the claims
rebuts the Examiner’s showing that the invention as recited in claim 1 recites
anything more than generic components and functionality, employing a
process a human can perform, and a system of organizing human activity,
managing behavior by following rules or instructions, and teaching, by
presenting PRI that a clinician can relay to a patient.11
As noted in the Guidance, courts have found that “[a]n additional
element [that] merely recites the words ‘apply it’’ (or an equivalent) with the
judicial exception, or merely includes instructions to implement an abstract
idea on a computer, or merely uses a computer as a tool to perform an
abstract idea,” may not integrate the judicial exception into a practical
application. Guidance, 84 Fed. Reg. at 55. Here, the Examiner shows that
claim 1 involves applying generic computer components and functionality as
tool to create information, namely PRI.

11 Under the Guidance, 84 Fed. Reg. at 55, even “conventional elements
may still integrate an exception into a practical application.”
Appeal 2019-000810
Application 12/441,184

37
Specifically, claim 1 requires the “decision support mechanisms” to
“process input data” into “PRI” using several databases each containing
different types of data. Claim 1 does not specify anything more than “using”
the databases in a generic configuration. The “inference engine” “is
configured to classify asserted facts in the knowledge base,” but the
“decision support mechanism” merely “us[es]” the “knowledge base” and
other databases, and does not necessarily even use the “asserted facts” that
the “inference engine . . . is configured to classify.” Claim 1 also requires
the decision support mechanism to be “operably coupled . . . so as to
interact” during the “processing” of the input data into PRI. Appellant does
not rely on the “operably coupled . . . so as to interact” during processing
feature. Nevertheless, computer system components generally and typically
interact during processing, and claim 1 specifies no special interaction or
processing.
The Specification states “the present invention does not provide a
diagnosis as part of the patient related information PRI.” Spec. 8:10–11. It
also states “the present invention is intended for application on a single
patient at a time.” Id. at 6:31. As the Examiner recognizes, claim 1 operates
at a high degree of generality simply to gather and process data. See Final
Act. 6 (“The molecular diagnostic support system, the patient database, and
the middleware section are recited at a high level of generality and are
recited as performing generic computer functions routinely used in computer
applications.”). Appellant does not provide persuasive argument rebutting
this finding.
In other words, the claims combine a mental process and organizing
human activity to create PRI information that a doctor or counselor would
Appeal 2019-000810
Application 12/441,184

38
have used manually to assist a patient, by implementing the execution of
mental steps or rules performed by generic computer software or hardware
components. See Credit Acceptance Corp. v. Westlake Svcs., 859 F.3d 1044,
1055 (Fed. Cir. 2017) (“Our prior cases have made clear that mere
automation of manual processes using generic computers does not constitute
a patentable improvement in computer technology.”). Moreover, “relying
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) (citing Alice, 573
U.S. at 224 (“use of a computer to create electronic records, track multiple
transactions, and issue simultaneous instructions” is not an inventive
concept)); Bancorp Servs., L.L.C. v. Sun Life Assur. Co. of Can. (U.S.), 687
F.3d 1266, 1278 (Fed. Cir. 2012) (a computer “employed only for its most
basic function . . . does not impose meaningful limits on the scope of those
claims”).
The Specification supports the Examiner’s contention that the claimed
invention involves generic components combined in a highly generic
manner. As one example, the Specification states “[t]he elements and
components of an embodiment of the invention may be physically,
functionally and logically implemented in any suitable way. Indeed, the
functionality may be implemented in a single unit, in a plurality of units or
as part of other functional units.” Spec. 8:16–19 (emphasis added). As
another example, the Specification states “[t]he guideline execution engine
CL-EE and inference engine IE are generic components of a decision
support system and have no specific requirements for a molecular diagnosis
application.” Id. at 9:19–21 (emphasis added). Also, according to the
Appeal 2019-000810
Application 12/441,184

39
Specification, the two decision support mechanisms recited in the claims
“are treated as ‘black boxes’” and “do not interfere with the internal working
of the other mechanism[s].” Id. at 8:30–33. Nothing in the Specification
indicates that any other components, including the several types of databases
recited in the claims and the “molecular diagnostics measurement device,”
do anything more than their generic functions.
The Specification also describes the knowledge data base in generic
terms: “The knowledge database KB 108 comprises what is necessarily or
prototypically true about a domain.” Id. at 7:8–9 (emphasis added).
Furthermore, the Specification states it uses “available off the shelf
components” for the “inference engine,” including “as an example,”
“Racer,” to “classify the asserted facts in the knowledge base KB to find the
correct position of a class in a hierarchy using the logical definition of the
classes.” Id. at 9:25–29 (emphases added). Employing “off the shelf”
generic components for the generic processes described here, namely
classifying asserted facts using logic, indicates the classification involves
steps humans performed long ago by following certain rules to arrive at
medical information to aid in a diagnosis, namely PRI as recited by claim 1.
As the Examiner recognizes, the mere mention of certain generic
computer components in claim 1 (e.g., “molecular diagnostic measurement
device,” “patient information database (EMJ),” “data input section (DAT),”
“clinical guideline database (CL),” “knowledge database (KB),” “first
decision support mechanism (1 DSM),” “second decision support
mechanism (2DSM),” “inference engine (IE),” “middleware (MW) section
interconnecting the patient information database (EMJ), the data input
section (DAT), the clinical guideline database (CL), the knowledge database
Appeal 2019-000810
Application 12/441,184

40
(KB), the first decision support mechanism (1DSM), and the second
decision support mechanism (2DSM)”) does not impose sufficiently
meaningful limitations on claim scope beyond these mental steps and human
activity. See Final Act. 6–7; CyberSource Corp. v. Retail Decisions, Inc.,
654 F.3d 1366, 1375 (Fed. Cir. 2011) (“[W]e have never suggested that
simply reciting the use of a computer to execute an algorithm that can be
performed entirely in the human mind” renders a claim patent eligible).
As noted above, Appellant groups claims 1–13 together. Based on the
foregoing discussion, Appellant does not show error in the Examiner’s
determination that claims 1–13 recite nonstatutory subject matter.
Guidance, Step 2B and Alice/Mayo Step 2
Step 2B of the Guidance tracks Step 2 of the Alice/Mayo framework,
and requires determining whether the claims (a) add a specific limitation or
combination of limitations that are not well-understood, routine,
conventional activity in the field, or (b) simply append well-understood,
routine, conventional activities previously known to the industry, specified
at a high level of generality, to the judicial exception. See Guidance, 84
Fed. Reg. at 56. The Examiner finds that the claims do not include
additional elements that amount to significantly more than the abstract idea.
Final Act. 6. Rather, the Examiner finds the additional elements beyond the
abstract idea are merely “[g]eneric computer components” that perform
“generic computer functions that are well-understood, routine and
conventional activities.” Id. In addition, as described in the previous
section, claim 1 embraces generic components and functionality, and here,
these generic components and functionality include within their scope well-
understood, routine, and conventional components and activities.
Appeal 2019-000810
Application 12/441,184

41
Based on the software components listed by Appellant as quoted
above with respect to prong 2, Step 2A, Appellant contends “the present
teachings the system overcomes at least a shortage in trained technicians.”
Appeal Br. 16. Nothing in Appellant’s arguments or the Specification reveal
how the claimed system overcomes the shortage, other than using a
computer as a tool to implement the basic abstract idea. Appellant cites
Federal Circuit precedent involving claims reciting an inventive concept, but
Appellant fails to rebut the Examiner’s showing that the claims here do
anything more than append well-understood, routine, conventional activities
previously known to the industry, at a high level of generality, to the judicial
exception. See Appeal Br. 15–16 (citing, e.g., BASCOM Global Internet
Svcs. Inc. v. AT&T Mobility LLC, 827 F.3d 1341 (Fed. Cir. 2016)).
As discussed above, the claims are directed to gathering and
manipulating information to create other information, namely PRI data.
Viewed individually and as a whole, nothing in claim 1 adds significantly
more (i.e., an inventive concept) to the abstract idea. As set forth above, the
additional elements in claim 1 amount to no more than mere instructions to
apply the judicial exception using generic computer components and
functionality, an insufficient application to provide an inventive concept.
Appellants do not direct attention to anything in the Specification that
indicates the claimed computer components and functionality involves
anything more than receiving and outputting data, as the Examiner
determines. See Elec. Power, 830 F.3d at 1355 (“Nothing in the claims,
understood in light of the specification, requires anything other than off-the-
shelf, conventional computer, network, and display technology for
gathering, sending, and presenting the desired information.”); buySAFE, Inc.
Appeal 2019-000810
Application 12/441,184

42
v. Google, Inc., 765 F.3d 1350, 1355 (Fed. Cir. 2015) (“That a computer
receives and sends information over a network—with no further
specification—is not even arguably inventive.”); Alice, 573 U.S. at 224–26
(receiving, storing, sending information over networks insufficient to add an
inventive concept).
BASCOM involved claims generally directed to filtering content. 827
F.3d at 1348. Although the Federal Circuit determined the claims recited
generic computer, network, and Internet components, deemed not inventive
individually, the Federal Circuit found the ordered combination of the
components and other limitations provided the requisite inventive concept.
Id. at 1349–1350 (“[A]n inventive concept can be found in the non-
conventional and non-generic arrangement of known, conventional pieces”).
There, the patent claimed and explained how a particular arrangement of
elements creates “a technical improvement over prior art ways of filtering
such content.” Id. at 1350 (“According to BASCOM, the inventive concept
harnesses this technical feature of network technology in a filtering system
by associating individual accounts with their own filtering scheme and
elements while locating the filtering system on an ISP server.”).
Unlike in BASCOM, Appellant does not explain adequately how the
Examiner erred in determining that the claims perform nothing more than
routine, conventional functions of generic software or hardware computer
components to gather and create information that manually could have been
gathered and created, namely PRI. In contrast to BASCOM, claim 1 does not
require any non-conventional computer components, or a “non-conventional
and non-generic arrangement of known, conventional pieces,” cf. id. at 1350,
but merely calls for performance of the claimed information of receiving,
Appeal 2019-000810
Application 12/441,184

43
processing, and producing PRI “on a set of generic computer components.”
See id.
As noted above, Appellant groups claims 1–13 together. Based on the
foregoing discussion, Appellant does not show error in the Examiner’s
determination that claims 1–13 recite nonstatutory subject matter in violation
of 35 U.S.C. § 101.
E. Claim 13, Anticipation
The Examiner rejects claim 13 as anticipated by Avinash. In the
rejection, the Examiner reads all the claim elements onto Avinash’s medical
diagnostic system. See Final Act. 17–19. Regarding the step of classifying
by the inference engine, the Examiner finds Avinash discloses it as follows:
classifying by the interference engine (IE) asserted facts in the
knowledge base (KB) (paragraph 288, use experts to categorize
the data) to determine a correct position of a class of classes in a
hierarchy using logical definitions of classes (paragraph 288,
example provided -This is the intended result of the classification
as such the Examiner does not make a relative rejection regarding
how the “hierarchy” is determined. This could also simply
being sorting data as the specification provides zero guidance),
Final Act. 18–19.
The Examiner also finds paragraphs 285–288 of Avinash disclose an
inference engine as part of an integrated knowledge base. Id. at 18.
In response, Appellant directs attention and argument to the
classifying step employing the inference engine (IE) as recited in claim 13.
Appeal Br. 24–25. In particular, Appellant argues Avinash “fails to disclose
an IE, or the classifying thereby of asserted facts in the knowledge base to
determine a correct position of a class of classes in a hierarchy.” Id. at 25.
Appellant does not explain why Avinash does not disclose providing the IE
or the classifying step. Appellant does not point to any particular error in the
Appeal 2019-000810
Application 12/441,184

44
Examiner’s findings, as quoted above. Appellant’s argument, therefore,
amounts to a mere denial without explanation, thereby waiving any
argument directed to claim 13.
Even if Appellant does not waive the argument, the Examiner shows
persuasively that claim 13 reads on Avinash, including the recited IE and
classifying step. The disputed steps follows: “providing an inference engine
(IE) . . . and classifying by the inference engine (IE) asserted facts in the
knowledge base (KB) to determine a correct position of a class of classes in
a hierarchy using logical definitions of the classes.” See Appeal Br. 24–25
(quoting the disputed step, comma omitted).
At the paragraph cited by the Examiner, Avinash discloses an
“automated” “classification process” employing, inter alia, the following
initial steps: “collect representative data for a particular clinical event, set up
a domain-expert panel to review the data, use experts to categorize the data
into different valid groupings, and corroborate the expert findings with some
reference standard technique. Avinash ¶ 288; Final Act. 17–19. In addition,
the paragraphs cited by the Examiner describe an “INTEGRATED
KNOWLEDGE BASE,” created by filtering and processing data (i.e., an
inference engine), using various algorithmic programs, integrating of all
types of health and other data, including expert opinion data, using rules and
predictive models. See Avinash ¶¶ 285–288. Appellant does not explain
why placing and categorizing data from Avinash’s integrated knowledge
base into different valid groupings using an automated algorithmic process
fails to satisfy “classifying asserted facts in the knowledge base . . . to
determine a correct position of a class of classes in a hierarchy using logical
Appeal 2019-000810
Application 12/441,184

45
definitions of the classes” with an inference engine. We adopt and
incorporate the Examiner’s findings as persuasive. See Final Act. 17–19.
Moreover, claim 13 does not specify how the claimed “computer
readable medium,” “configured to enable a method” that includes “providing
an inference engine,” provides the inference engine, implying at most, that
the inference engine constitutes part of an intended use for the claimed
“computer readable medium.” Claim 13 also does not specify how the
inference engine interacts with the remaining claim steps. The “processing”
step implemented by the “decision support mechanism” includes “using . . .
the knowledge database (KB),” and the inference engine classifies “asserted
facts in the knowledge base,” but claim 13 does not require using the
“asserted facts” of the KB in the processing step or otherwise. See Spec.
9:17–18 (“[T]he knowledge database KB 406 is operably connected to
communicate with an interference engine IE 408.”). Given the breadth of
claim 13 and the lack of interconnection with other components and steps
recited in clam 13, the Examiner shows persuasively that claim 13’s
inference engine and classifying step read on the processing functionality
and structure involved in Avinash’s integrated knowledge database. See
Final Act. 17–19.
Based on the foregoing discussion, Appellant does not show error in
the Examiner’s anticipation rejection of claim 13.
F. Claims 1–12, Obviousness
The Examiner rejects claims 1–12 for obviousness over Avinash and
Lu. See Final Act. 10–17. The obviousness rejection involves the same
material issue as the anticipation rejection, because Appellant advances the
same argument regarding the inference engine and classifying step.
Appeal 2019-000810
Application 12/441,184

46
Appellant does not present arguments for any other claim element, and relies
on its arguments for claim 1. Appeal Br. 23–24. Therefore, claim 1
represents the claims on appeal for this obviousness rejection.
For the same reasons explained above in connection with the
anticipation rejection of claim 13, Appellant waives the argument with
respect to claim 1. In short, Appellant presents a mere denial and fails to
present a clear argument as to how the Examiner erred in the obviousness
determination. See Appeal Br. 23–24. Also, for similar reasons set forth
above in the anticipation discussion, even if Appellant does not waive the
argument, Appellant does not show error in the Examiner’s determination of
obviousness, because Avinash discloses the inference engine and its function
of classifying asserted facts, as the Examiner determines and as explained
above. See id.; Final Act. 10; supra Section V.E.
Unlike claim 13, claim 1 does not involve an intended use of an
inference engine, as it positively recites an inference engine and knowledge
base, as follows:
wherein the inference engine (IE) is configured to classify
asserted facts in the knowledge base (KB) to determine a correct
position of a class of classes in a hierarchy using logical
definitions of the classes,
wherein the first (1DSM) and the second (2DSM) decision
support mechanisms process input data (MDx) into patient
related information (PRI) using the patient information database
(EMJ), the clinical guideline database (CL) and the knowledge
database (KB).
Similar to claim 13, however, claim 1 does not specify how the
inference engine interacts with the remaining claim components. The
“process” function of the decision support mechanisms include “using . . .
the knowledge database (KB),” and the inference engine classifies “asserted
Appeal 2019-000810
Application 12/441,184

47
facts in the knowledge base,” but nothing in claim 1 requires using the
“asserted facts” during the “process” function of the support mechanisms, or
otherwise. Accordingly, the Examiner shows that Avinash discloses the
claimed inference engine and classifying function as part of the processing
involved in Avinash’s knowledge database, as discussed above in
connection with claim 13. See Final Act. 10 (citing Avinash ¶¶ 285–288).
We adopt and incorporate the Examiner’s findings and determination of
obviousness as persuasive. See id. at 10–17.
Based on the foregoing discussion, Appellant does not show error in
the Examiner’s obviousness rejection of claims 1–12.
VI. CONCLUSION
We affirm the Examiner’s Decision finally rejecting the claims, as
follows: The rejection of claims 1–13 under 35 U.S.C. § 101 as directed to
non-statutory subject matter; the rejection of claims 1–13 under 35 U.S.C.
§ 112, ¶ 1 for lack of written description; the rejection of claims 1–12 under
35 U.S.C. § 112, ¶ 2 for indefiniteness; the rejection of claim 13 under 35
U.S.C. § 102 for anticipation; and, the rejection of claims 1–12 under 35
U.S.C. § 103 for obviousness over Avinash and Lu.
VII. DECISION SUMMARY
Claims
Rejected
35 U.S.C. § Basis/References  Affirmed Reversed
1–12 112 2nd Indefiniteness 1–12
1–13 112 1st Written Description 1–13
1–13 101 Nonstatutory Subject
Matter
1–13
13 102 Anticipation, Avinash 13
1–12 103 Obviousness, Avinash,
Lu
1–12
Appeal 2019-000810
Application 12/441,184

48
Claims
Rejected
35 U.S.C. § Basis/References  Affirmed Reversed
Overall
Outcome
1–13
VIII. 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