Suffin, Stephen et al.

Patent Trials and Appeals Board

May 15, 2020

2019003430 (P.T.A.B. May. 15, 2020)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/616,342 09/14/2012 Stephen Suffin 340005-2026.2 4688
20999 7590 05/15/2020
HAUG PARTNERS LLP
745 FIFTH AVENUE - 10th FLOOR
NEW YORK, NY 10151
EXAMINER
REICHERT, RACHELLE LEIGH
ART UNIT PAPER NUMBER
3686
NOTIFICATION DATE DELIVERY MODE
05/15/2020 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):
docket@haugpartners.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte STEPHEN SUFFIN and CARL GARBER
____________

Appeal 2019-003430
Application 13/616,342
Technology Center 3600
____________

Before BRUCE T. WIEDER, TARA L. HUTCHINGS, and
ROBERT J. SILVERMAN, Administrative Patent Judges.

WIEDER, Administrative Patent Judge.

DECISION ON APPEAL
Appellant1 seeks review under 35 U.S.C. § 134 from the Examiner’s
final rejection of claim 7. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies the real party in interest as Quest
Diagnostics Investments Incorporated. (Appeal Br. 1.)
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CLAIMED SUBJECT MATTER
Appellant’s invention relates to “a method . . . of calculating a
reference range.” (Spec. ¶ 5.)
Claim 7 is the sole claim on appeal. It recites:
7. A method of providing a reference range applicable to a
measurement of an analyte in a medical test performed on
biological material obtained from a patient at a collection time,
the method being performed by a computer system comprising
one or more processors, one or more computer-readable storage
media operatively connected to at least one of the processors, and
one or more interfaces operatively connected to at least one of
the processors, and the method comprising:
receiving through at least one of the interfaces a plurality
of prior values, each prior value being a measurement of a
respective value of the analyte in a respective member of a
population comprising a plurality of individuals;
dividing the population into a plurality of subpopulations
by applying one or more criteria to the plurality of individuals,
each subpopulation comprising a plurality of the plurality of
individuals;
associating each of the prior values with a respective one
of the subpopulations by applying the one or more criteria to the
respective individual in whom the respective prior value was
measured;
for each subpopulation, determining that a statistical
property of the prior values associated with that subpopulation
varies according to a time-periodic function, the time-periodic
function being a mathematical function such that for all times t
and a fixed time interval T, the value of the function at time t
equals the value of the function at time t + T;
subdividing the interval T into a plurality of subintervals;
for each subpopulation and for each subinterval, based on
the determined variation of the statistical property of the prior
values associated with that subpopulation, calculating a
reference range for the analyte that applies to the subpopulation
and the subinterval;
measuring a value of the analyte in the biological material;
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determining that the patient meets the criteria for inclusion
in one of the sub-populations and that the collection time falls
within a subinterval;
retrieving the reference range that applies to the one of the
subpopulations and the subinterval; and
transmitting through at least one of the interfaces the
measured value and the retrieved reference range.

REJECTION
Claim 7 is rejected under 35 U.S.C. § 101 as directed to a judicial
exception without significantly more.

ANALYSIS
“Whoever invents or discovers any new and useful process, machine,
manufacture, or composition of matter, or any new and useful improvement
thereof, may obtain a patent therefor, subject to the conditions and
requirements of this title.” 35 U.S.C. § 101. Section 101, however,
“contains an important implicit exception: Laws of nature, natural
phenomena, and abstract ideas are not patentable.” Alice Corp. Pty. Ltd. v.
CLS Bank Int’l, 573 U.S. 208, 216 (2014) (quoting Ass’n for Molecular
Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589 (2013)).
Alice applies a two-step framework, earlier set out in Mayo
Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66
(2012), “for distinguishing patents that claim laws of nature, natural
phenomena, and abstract ideas from those that claim patent-eligible
applications of those concepts.” Alice, 573 U.S. at 217.
Under the two-step framework, it must first be determined if “the
claims at issue are directed to a patent-ineligible concept.” Id. at 218. If the
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claims are determined to be directed to a patent-ineligible concept, e.g., an
abstract idea, then the second step of the framework is applied to determine
if “the elements of the claim . . . contain[] an ‘ “inventive concept” ’
sufficient to ‘transform’ the claimed abstract idea into a patent-eligible
application.” Id. at 221 (citing Mayo, 566 U.S. at 72–73, 79).
With regard to step one of the Alice framework, we apply a “directed
to” two-prong test to: 1) evaluate whether the claim recites a judicial
exception, and 2) if the claim recites a judicial exception, evaluate whether
the claim “appl[ies], rel[ies] on, or use[s] the judicial exception in a manner
that imposes a meaningful limit on the judicial exception, such that the claim
is more than a drafting effort designed to monopolize the judicial
exception.” See USPTO, 2019 Revised Patent Subject Matter Eligibility
Guidance, 84 Fed. Reg. 50, 54 (Jan. 7, 2019) (hereinafter “2019 Guidance”).
Here, the Examiner determines that “[c]laim 7 is directed to a method
of providing a reference range” (Final Action 2), and that “[t]he calculating
of a reference range using data from a plurality of members of a population
describes the abstract idea” (id. at 3). The Examiner determines that claim 7
is directed to the abstract idea of mental processes. (Answer 5.)
Appellant argues that “the inventors discovered variability in
distributions of values for various analytes in various populations.” (Appeal
Br. 5–6 (citing Spec. ¶ 33).) Appellant further argues that “[c]laim 7 is
directed to a single, specific application of this discovery: a method of
providing a reference range applicable to a measurement of an analyte” (id.
at 6), and that “[t]he claimed method thus, in a specific way, makes
laboratory test results more useful for diagnosis and so represents a specific
improvement to medical testing technology” (id.).
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Under step one of the Alice framework, we “look at the ‘focus of the
claimed advance over the prior art’ to determine if the claim’s ‘character as a
whole’ is directed to excluded subject matter.” Affinity Labs of Texas, LLC
v. DIRECTV, LLC, 838 F.3d 1253, 1257 (Fed. Cir. 2016) (quoting Elec.
Power Grp., LLC v. Alstom S.A., 830 F.3d 1350, 1353 (Fed. Cir. 2016).
The “directed to” inquiry . . . cannot simply ask whether the
claims involve a patent-ineligible concept, because essentially
every routinely patent-eligible claim involving physical products
and actions involves a law of nature and/or natural phenomenon
. . . . Rather, 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.” Internet Patents Corp. v. Active Network, Inc.,
790 F.3d 1343, 1346 (Fed. Cir. 2015).

Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335 (Fed. Cir. 2016). In
other words, the first step of the Alice framework “asks whether the focus of
the claims is on the specific asserted improvement in [the relevant
technology] or, instead, on a process that qualifies as an ‘abstract idea’ for
which computers are invoked merely as a tool.” Id. at 1335–36; see also
2019 Guidance at 54–55.
The Specification provides evidence as to what the claimed invention
is directed. In this case, the Specification discloses that the invention relates
to “a method . . . of calculating a reference range.” (Spec. ¶ 5.) Claim 7
provides additional evidence. Claim 7 recites “[a] method of providing a
reference range applicable to a measurement of an analyte . . . , the method
being performed by a computer . . . comprising: receiving . . . a plurality of
prior values,” “dividing the population into a plurality of subpopulations,”
“associating each of the prior values with a respective one of the
subpopulations,” “for each subpopulation, determining that a statistical
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property of the prior values . . . varies according to a time-periodic
function,” “subdividing the interval,” “calculating a reference range,”
“measuring a value of the analyte,” “determining that the patient meets the
criteria for inclusion in one of the sub-populations,” “retrieving the
[applicable] reference range,” “and transmitting . . . the measured value and
the retrieved reference range.” In sum, claim 7 recites providing data in the
form of a reference range for the evaluation of a measurement.
The generic computer system recited in claim 7 (see Spec. ¶ 17)
receives data, analyzes data (performing operations on the data), measures a
value of the analyte,2 evaluates the data (determines that criteria are met),
retrieves data, and transmits data. While claim 7 provides a level of detail
with regard to the procedure for performing the data analysis, the claimed
steps can be performed in the human mind or with the aid of pen and paper.
Appellant disagrees and argues that “‘[i]t is commonly stated that 120
is the number of data points needed for a reference interval study.’ Graham
Jones & Anthony Barker, Reference Intervals, CLINICAL BIOCHEMIST
REVS. (Supp. 1) S93, S95 (Aug. 2008) (Pubmed ID: 18852866).” (Reply
Br. 3 (alteration in original).) Therefore, Appellant argues, “read in light of
the specification, the claims recite a method involving mathematical analysis

2 The Specification does not indicate how the computer system directly
“measur[es] a value of the analyte in the biological material,” as recited in
claim 7. Instead, the Specification discloses that “one or more computer
systems . . . may calculate and/or store, retrieve, manipulate, analyze,
transmit, and/or receive data related to values of analytes measured, e.g., in
laboratory tests.” (Spec. ¶ 29; see also id. ¶¶ 30, 44, 46.) Applying a
broadest reasonable interpretation, in this case, we interpret this limitation to
include retrieving data related to values of analytes measured from
laboratory tests, e.g., from a laboratory testing device.
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and correlation of at least hundreds of data points. This work is not
reasonably done mentally, even with the assistance of pencil and paper.”
(Id.)
Appellant’s argument is simply that more data points produce better
results. But this does not bear upon the issues before the Board, at least
because Appellant does not point to language in claim 7 or in the
Specification that would result in a broadest reasonable interpretation of
claim 7 requiring “at least hundreds of data points.” In short, Appellant does
not persuasively argue why the Examiner erred in determining that
if the population size was small enough (i.e., a population size of
5 patients), the calculations are able to be performed mentally.
The specification does not provide any specifics regarding the
population size, and under the broadest reasonable interpretation
standard, the population size could be interpreted as small as two
patients. Calculations for a relatively small sample size could be
done mentally by a person.

(Answer 5.) 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).
The evidence shows that claim 7 is directed to “selecting certain
information, analyzing it using mathematical techniques, and reporting or
displaying the results of the analysis. That is all abstract.” SAP Am., Inc. v.
InvestPic, LLC, 898 F.3d 1161, 1167 (Fed. Cir. 2018). Receiving, analyzing
and transmitting data have been determined to be directed to an abstract
idea. See, e.g., Berkheimer v. HP Inc., 881 F.3d 1360, 1366 (Fed. Cir. 2018)
(determining parsing, comparing, and storing data to be directed to an
abstract idea), FairWarning IP, LLC v. Iatric Sys., Inc., 839 F.3d 1089,
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1093–94 (Fed. Cir. 2016) (determining “that the ‘realm of abstract ideas’
includes ‘collecting information, including when limited to particular
content’” as well as analyzing and presenting information). Thus, “with the
exception of generic computer-implemented steps, there is nothing in the
claims themselves that foreclose them from being performed by a human,
mentally or with pen and paper.” Intellectual Ventures I LLC v. Symantec
Corp., 838 F.3d 1307, 1318 (Fed. Cir. 2016). Activities that can be
performed in the human mind or with pen and paper (“including an
observation, evaluation, judgment, opinion”) are characterized as the
abstract idea of mental processes.3 (See Guidance 2019 at 52.)
Nor does claim 7 recite technological implementation details for any
of the steps. Claim 7 does not recite “a particular way of programming or
designing the software . . . , but instead merely claim[s] the resulting
system[].” Apple, Inc., 842 F.3d at 1241. For example, claim 7 does not
recite how the computer system receives the prior values, how it divides the
population into subpopulations, how it associates prior values with
subpopulations, how it measures a value of the analyte, how it retrieves
reference ranges, or how it transmits the measured value and retrieved range.
Appellant’s Specification makes clear that the computer system was
well known. (See, e.g., Spec. ¶ 17.) Claim 7 does not recite any specific
asserted improvement to the computer system or other computer technology.

3 Although we and the Examiner describe, at different levels of abstraction,
to what the claims are directed, it is recognized that “[a]n abstract idea can
generally be described at different levels of abstraction.” Apple, Inc. v.
Ameranth, Inc., 842 F.3d 1229, 1240 (Fed. Cir. 2016). That need not, and in
this case does not, “impact the patentability analysis.” See id. at 1241.

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Appellant’s asserted “improvement to medical testing technology” (Appeal
Br. 5), is simply an improvement to the abstract idea, i.e., the mental
processes used to evaluate particular data. But “[n]o matter how much of an
advance in the . . . field the claim[] recite[s], the advance lies entirely in the
realm of abstract ideas, with no plausibly alleged innovation in the non-
abstract application realm.” SAP Am., Inc. 898 F.3d at 1163.
In cases involving software innovations, such as we have here, the
inquiry as to whether the claims are directed to an abstract idea “often turns
on whether the claims focus on ‘the specific asserted improvement in
computer capabilities ... or, instead, on a process that qualifies as an
“abstract idea” for which computers are invoked merely as a tool.’” Finjan,
Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1303 (Fed. Cir. 2018) (quoting
Enfish, LLC, 822 F.3d at 1335–36). Here, the computer system is invoked
merely as a tool.
Regardless, Appellant seeks to analogize claim 7 to the claims in
McRO, Inc. v. Bandai Namco Games America Inc., 837 F.3d 1299 (Fed.
Cir. 2016). (Appeal Br. 11–12, Reply Br. 3–5.) But claim 7 simply uses a
generic computer system to perform the abstract idea; in this case, the steps
of receiving, analyzing/evaluating, and transmitting data. This does not
improve the computer system. In contrast, “[t]he claimed improvement [in
McRO] was to how the physical display operated (to produce better quality
images).” SAP Am., Inc., 898 F.3d at 1167. Here, although claim 7 recites,
e.g., “receiving,” “associating,” “determining,” “retrieving,” and
“transmitting,” Appellant does not sufficiently explain how these steps
improve the technology. As discussed above, the claimed improvement is to
the abstract idea, i.e., the mental processes used to evaluate particular data.
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Moreover, we 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 or functionality to the claimed
invention or that otherwise indicates that the claimed invention “appl[ies],
rel[ies] on, or use[s] the judicial exception in a manner that imposes a
meaningful limit on the judicial exception, such that the claim is more than a
drafting effort designed to monopolize the judicial exception.” (See 2019
Guidance at 54–55.)
Thus, under prong one of the two prong test in the 2019 Guidance,
claim 7 recites an abstract idea, i.e., mental processes; and, under prong two,
additional elements in claim 7 do not “apply, rely on, or use the judicial
exception in a manner that imposes a meaningful limit on the judicial
exception, such that the claim is more than a drafting effort designed to
monopolize the judicial exception.” (See id. at 54.) As such, under step one
of the Alice framework, claim 7 is directed to an abstract idea, and we move
to step two.
Step two of the Alice framework has been described “as a search for
an ‘ “inventive concept” ’ –i.e., an element or combination of elements that
is ‘sufficient to ensure that the patent in practice amounts to significantly
more than a patent upon the [ineligible concept] itself.’” Alice, 573 U.S.
at 217–18 (brackets in original) (quoting Mayo, 566 U.S. at 72–73). Under
step two, we examine, inter alia, whether a claim element or combination of
elements “[a]dds a specific limitation or combination of limitations that are
not well-understood, routine, conventional activity in the field, which is
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indicative that an inventive concept may be present.” (2019 Guidance
at 56.)
Appellant argues that “the recited reliance on time-periodicity of
values in a population to calculate reference ranges for laboratory tests is an
unconventional analysis.” (Appeal Br. 12.) Appellant further argues that
“[w]hether a claim element or combination of elements is well-
understood, routine and conventional to a skilled artisan in the
relevant field is a question of fact.” Berkheimer v. HP Inc., 881
F.3d 1360, 1368 . . . (Fed. Cir. 2018). The examiner has adduced
no evidence suggesting that the inventor did not discover the
underlying principle or that the claimed analysis is otherwise
conventional.

(Id.) We do not find this argument persuasive.
As an initial matter, we note that “reliance on time-periodicity of
values” is part of the procedure for performing the data analysis, i.e., in this
case, part of the abstract idea. (See supra.) And even if the claimed
techniques are “[g]roundbreaking, innovative, or even brilliant,” that is not
enough for patent eligibility. Ass’n for Molecular Pathology, 569 U.S.
at 591. “The ‘novelty’ of any element or steps in a process, or even of the
process itself, is of no relevance in determining whether the subject matter of
a claim falls within the § 101 categories of possibly patentable subject
matter.” Diamond v. Diehr, 450 U.S. 175, 188–89 (1981).
The steps of receiving, analyzing/evaluating, and transmitting data are
well-understood, routine and conventional. These are all routine and
conventional functions for a computer system and were previously known to
the industry. See Elec. Power Grp., 830 F.3d at 1356 (The claims “do not
include any requirement for performing the claimed functions of gathering,
analyzing, and displaying in real time by use of anything but entirely
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conventional, generic technology. The claims therefore do not state an
arguably inventive concept . . . .”), In re Katz Interactive Call Processing
Patent Litig., 639 F.3d 1303, 1316 (Fed. Cir. 2011) (“Absent a possible
narrower construction of the terms ‘processing,’ ‘receiving,’ and ‘storing,’
. . . those functions can be achieved by any general purpose computer
without special programming.”) Taking the claim elements separately, the
functions performed in claim 7 by the generic computer system are purely
routine and conventional.
Considered as an ordered combination, the generic computer system
of Appellant’s claimed invention adds nothing that is not already present
when the limitations are considered separately. For example, claim 7 does
not, as discussed above, purport to improve the functioning of the computer
system itself. Nor does it effect an improvement in any other technology or
technical field. Instead, claim 7 amounts to nothing significantly more than
an instruction to apply the abstract idea using a generic computer system
performing routine computer functions. That is not enough to transform an
abstract idea into a patent-eligible invention. See Alice, 573 U.S. at 225–26.
In view of the above, we are not persuaded the Examiner erred in
rejecting claim 7 under § 101.

CONCLUSION
The Examiner’s rejection of claim 7 under 35 U.S.C. § 101 is
affirmed.
Specifically:
Claim
Rejected
35 U.S.C. § Reference(s)/Basis  Affirmed Reversed
7 101 Eligibility 7
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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