Ex Parte Fairchild et al

Patent Trial and Appeal Board

Nov 17, 2017

13695243 (P.T.A.B. Nov. 17, 2017)

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.
13/695,243 03/11/2013 Karen D. Fairchild 0087407-000140 4874
143284 7590 11/21/2017
University of Virginia Licensing and Ventures
Group
c/o Buchanan Ingersoll & Rooney PC
Post Office Box 1404
Alexandria, VA 22314
EXAMINER
STANFIELD, CHERIE MICHELLE
ART UNIT PAPER NUMBER
1647
NOTIFICATION DATE DELIVERY MODE
11/21/2017 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):
ADIPDOCl@bipc.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KAREN D. FAIRCHILD, JEFFREY SAUCERMAN,
RANDALL J. MOORMAN, and DOUGLAS E. LAKE
Appeal 2017-001073
Application 13/695,243
Technology Center 1600
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal1 under 35U.S.C. § 134 involving claims to a system
configured to determine the presence of particular infective organism or
blood culture result in an infant. The Examiner rejected the claims as not
directed to patent eligible subject matter and as obvious. We have
jurisdiction under 35 U.S.C. § 6(b). We affirm.
Statement of the Case
Background
“Septic shock is the leading cause of morbidity and mortality in the
intensive care units” and “requires prompt treatment since the patient’s
1 Appellants identify University of Virginia Patent Foundation as the Real
Party in Interest (see App. Br. 1).
Appeal 2017-001073
Application 13/695,243
condition often deteriorates rapidly” (Wong2|| 2, 4). “Diagnosis is difficult
because the clinical signs are subtle and nonspecific, and lab tests including
‘gold standard’ blood cultures are not very reliable” (Spec. 1:26—28).
The Specification teaches the “present invention provides for, among
other things, the use of a biomarker test for sepsis at the time of a rise in the
HRC index that can aid clinicians in distinguishing patients with sepsis from
those with non-septic conditions, and allow for the identification of the
specific infective organism” (Spec. 2:24—28).
The Claims
Claims 17—29 are on appeal. Independent claim 17 is representative
and reads as follows:
17. A system configured to determine the presence of a
specific class of infective organism and/or blood culture result
in an infant, wherein said system comprises:
a measuring device configured to measure heart rate
characteristics (HRC) of said infant;
a sampling device for measuring the levels of one or
more biochemical substances in one or more biologic samples
from said infant; and
at least on processor configured to:
identify a higher than normal risk of having said
specific class of infective organism or blood culture
result based on values from said measuring device,
in response to identification of a higher than
normal risk of having said specific class of infective
organism or blood culture result, assess levels of said one
2 Wong, H., WO 2008/143890 A2, published Nov. 27, 2008.
2
Appeal 2017-001073
Application 13/695,243
or more biochemical substances measured by said
sampling device against a target value, and
interpret said levels against predefined criteria to
provide said determination of the presence of a specific
class of infective organism or blood culture result in the
infant.
The Issues3
A. The Examiner rejected claims 17—29 under 35 U.S.C. § 101 because
the claimed invention is not directed to patent eligible subject matter (Ans.
4—12).
B. The Examiner rejected claims 17—29 under 35 U.S.C. § 103(a) as
obvious over Wong, Griffin,4 Chappell,5 Kumar,6 Khassawneh,7 and
Tirodker8 (Ans. 13—18).
A. 35 U.S.C. §101
The Examiner rejects all of the claims on appeal under 35 U.S.C. §
101 as being directed to patent-ineligible subject matter. Specifically, the
3 Claims 1—16 and 33—43 were withdrawn from prosecution based on
Appellants election in the Resp. Election/Restriction filed July 16, 2014.
Claims 30—32 were cancelled in the Amendment filed Mar. 16, 2015.
4 Griffin et al., Heart Rate Characteristics and Clinical Signs in Neonatal
Sepsis, 61 Pediatric Res. 222-27 (2007).
5 Chappell et al., US 2006/0094056 Al, published May 4, 2006.
6 Kumar et al., Prognostic serum tumor necrosis factor-a in paediatric
patients with sepsis, 3 J. Infect. Dev. Countries 437-41 (2009).
7 Khassawneh et al., Diagnostic Markers for Neonatal Sepsis:
Comparing C-reactive Protein, lnterleukin-6 and Immunoglobulin M, 65
Scand. J. Immunol. 171-75 (2007).
8 Tirodker et al., Detection ofFungemia by Polymerase Chain Reaction in
Critically III Neonates and Children, 23 J. Perinatology 117—22 (2003).
3
Appeal 2017-001073
Application 13/695,243
Examiner finds that “the claims are determined to be directed to a law of
nature/natural principle” (Ans. 4). The Examiner reached this conclusion by
applying the test set out in Mayo Collaborative Services v. Prometheus
Laboratories, Inc., 566 U.S. 66 (2012) (Ans. 4—12) based on the two-step
Alice framework. Alice Corp. Pty. Ltd. v. CLSBankInt’l, 134 S. Ct. 2347,
2355 (2014).
Appellants contend “the claims are not directed to a biochemical
substance, biomarker, or any other naturally occurring product. To the
contrary, the pending claims are directed to a specific combination apparatus
comprising a heart rate characteristic measuring device, a biochemical
substance sampling device, and a specifically programmed processor” (App.
Br. 4). Appellants contend “the claimed apparatus uses the natural
phenomenon of heart rate characteristics and naturally occurring
biochemical substances to a new end, i.e. to determine the presence of a
specific class of infective organism or blood culture result in an infant” (Id.
at 5).
To determine whether a claim is invalid under § 101, we employ the
two-step Alice framework. In step one, we ask whether the claims are
directed to ineligible subject matter, such as a law of nature. Alice, 134
S. Ct. at 2355; Mayo, 566 U.S. at 75—77; Ariosa Diagnostics, Inc. v.
Sequenom, Inc., 788 F.3d 1371, 1375 (Fed. Cir. 2015). While apparatus
claims such as systems are generally eligible subject matter, system claims
that are directed only to natural phenomena are directed to ineligible subject
matter. See In re TLI Comm. LLC, 823 F.3d 607, 610 (Fed. Cir. 2016)
(finding apparatus and system claims patent ineligible).
4
Appeal 2017-001073
Application 13/695,243
Alice Step One
Claim 17 of the instant application is directed to the law of nature that
septic shock, and in particular organisms causing septic shock in infants, is
associated with particular heart rate characteristics and blood culture results.
The Specification teaches “the present invention provides for, among other
things, the use of a biomarker test for sepsis at the time of a rise in the HRC
[heart rate characteristics] index that can aid clinicians in distinguishing
patients with sepsis from those with non-septic conditions” (Spec. 2:24—27).
The Specification teaches that heart rate characteristics “can be
monitored on several types of devices. The signal may be obtained from a
subject and recorded using devices or machinery known in the art, e.g., heart
monitors, such as the heart rate characteristics index monitor (HeRO™,
Medical Predictive Science Corporation, Charlottesville, VA)” (Spec. 9:19—
22). The Specification teaches that the biochemical substance levels were
determined using known technologies, teaching “[s]even cytokines were
measured using a multiplex antibody-coated bead array with dual laser
fluorometric detection (Milliplex, Millipore, Billerica, MA). . . according to
the manufacturer’s instructions” (Spec. 15:22—27).
The claimed invention therefore is drawn to a system that measures
heart rate characteristics and biochemical substances using standard prior art
devices and correlating the results to the presence of organisms causing
septic shock, a relationship that is a patent-ineligible law of nature. Mayo,
566 U.S. at 77.
This case is similar to Ariosa, where the ineligible claims were
directed to a method of detecting paternally inherited cell-free fetal DNA,
5
Appeal 2017-001073
Application 13/695,243
which is naturally occurring in maternal blood. Ariosa, 788 F.3d at 1376.
The inventors there did not create or alter any of the genetic information
encoded in that DNA. Id. Likewise, here, the claims test heart rate
characteristics and biochemical substance levels which are naturally
occurring phenomenon. The system then employs the natural relationship
between those heart rate characteristics and biochemical substance levels to
predict an infant’s risk of having organisms associated with septic shock.
Thus, just like Ariosa, the system starts and ends with naturally occurring
phenomena with no meaningful non-routine steps in between— apparatus
for detection of the presence of particular heart rate characteristics and
biochemical substance levels that are correlated by a relationship to
organisms associated septic shock. The claims are therefore directed to a
natural law. Id.
Because the system claims are directed to a natural law, we turn to the
second step of the Alice framework.
Alice Step Two
In Alice step two, we examine the elements of the claims to determine
whether they contain an inventive concept sufficient to transform the
claimed naturally occurring phenomena into a patent-eligible application.
Mayo, 566 U.S. at 71—72, quoted in Alice, 134 S. Ct. at 2355. We must
consider the elements of the claims both individually and as an ordered
combination to determine whether additional elements transform the nature
of the claims into a patent-eligible concept. Ariosa, 788 F.3d at 1375.
We conclude that the practice of the system claims does not result in
an inventive concept that transforms the natural phenomena of heart rate
6
Appeal 2017-001073
Application 13/695,243
characteristics and biochemical substance levels being associated with
organisms related to septic shock into a patentable invention. Mayo and
Ariosa make clear that transforming claims that are directed to a law of
nature requires more than simply stating the law of nature while adding the
words “apply it.” Mayo, 566 U.S. at 72; Ariosa, 788 F.3d at 1377.
In Ariosa, the challenged claims involved a method that was a general
instruction to doctors to apply routine, conventional techniques when
seeking to detect paternally inherited cell-free fetal DNA in the blood serum
of a pregnant woman. Ariosa, 788 F.3d at 1377. The same is true here.
The system claims contain a “measuring device” that is configured to
measure heart rate characteristics. Appellants do not purport to have
invented such measuring devices, or any of the alternative ways to measure
heart rate characteristics in infants. Indeed, the Specification instructs that
heart rate characteristics be detected or determined using known, prior art,
devices (see, e.g., Spec. 9:19—23).
The system claims also contain a “sampling device” that measures the
level of biochemical substances in samples taken from the infant patient.
Appellants do not purport to have invented new sampling devices, or
measurement tests, but again the Specification exemplifies cytokine
measurements using prior art technologies (see, e.g., Spec. 15:22—27).
Finally, the system claims recite a “processor” that correlates the
levels obtained from the heart rate measuring device and biochemical
sampling device and then “interpret said levels against predefined criteria to
provide said determination of the presence of a specific class of infective
organism or blood culture result in the infant” (Claim 17). Here too,
7
Appeal 2017-001073
Application 13/695,243
Appellants do not purport to derive new mathematical or statistical methods
to arrive at the levels that would indicate an infant’s risk of infection, blood
culture results or septic shock. Just as in Mayo, the instant claims simply tell
doctors to (1) measure heart rate and levels of particular biochemical
substances, (2) use particular (unpatentable) laws of nature to calculate
levels associated with particular infectious organisms or culture results, and
(3) interpret the results to determine the organism or blood culture result in
the infected infant. See Mayo, 566 U.S. at 82.
These instructions add nothing specific to the laws of nature
other than what is well-understood, routine, conventional
activity, previously engaged in by those in the field And since
they are steps that must be taken in order to apply the laws in
question, the effect is simply to tell doctors to apply the law
somehow when treating their patients.
Id.
The claims, whether considered limitation-by-limitation or as a whole,
do not sufficiently transform the natural existence of heart rate
characteristics and biochemical substances that correlate to the presence of
organisms causing septic shock into a patentable invention. The system
elements here merely tell those “interested in the subject about the
correlations that the researchers discovered.” Mayo, 566 U.S. at 78.
We recognize, but find unpersuasive, Appellants’ argument that
“merely because the claimed system operates by measuring heart rate
characteristics and sampling biochemical substances, does not mean that the
claim is an attempt to pre-empt others from using a heart rate measurement
or from sampling a biochemical substance” (App. Br. 7).
8
Appeal 2017-001073
Application 13/695,243
In fact, because Appellants’ broadest claim does not identity any
specific heart rate characteristics or any biochemical substance, and the
claim does not limit the “specific class of infective organism” determined,
claim 17 broadly preempts the use of any biochemical test in combination
with heart rate for assessing any infective organisms or blood culture results,
while the Specification provides very limited discussion of a small set of
biochemical tests that may be used (see, e.g., Spec. 10:6—32) and limited, if
any, information connecting specific data with specific classes of organisms
(see Spec. 16:30 to 17:6). “The presence here of the basic underlying
concern that these patents tie up too much future use of laws of nature
simply reinforces our conclusion that the processes described in the patents
are not patent eligible, while eliminating any temptation to depart from case
law precedent.” Mayo, 566 U.S. at 87.
We recognize, but find unpersuasive, Appellants’ reliance on the
Federal Circuit decisions in Enfish, LLC v. Microsoft Corp., 822 F.3d 1327
(Fed. Cir. 2016) and McRO, Inc. v. Bandai Namco Games America Inc., 837
F.3d 1299 (Fed. Cir. 2016), contending the claim “is not directed to a
judicial exception, but rather, improvements in determining the presence of a
specific class of infective organism or blood culture result in an infant in
conjunction with the measuring and sampling devices” (Reply Br. 4).
Enfish explains that “the first step in the Alice inquiry in this case asks
whether the focus of the claims is 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.” Enfish,
822 F.3d at 1335—36. Applied to claim 17, there can be no reasonable doubt
9
Appeal 2017-001073
Application 13/695,243
that the claim does not teach any improvement in computer capabilities, or
indeed, any technical improvement in an apparatus, but rather focuses on a
system for applying the natural existence of heart rate characteristics and
biochemical substances that correlate to the presence of organisms or
biochemical causing septic shock. Similarly, the claims in McRO also were
drawn to improvements in the operation of a computer itself at a task, rather
than applying a computer to perform known tasks. See McRO, 837 F.3d at
1314. Therefore, neither case persuades us that Appellants’ system claims
relying on correlations using known components and prior art techniques are
patentable subject matter.
We therefore conclude that Supreme Court and Federal Circuit
precedent constrains us to conclude that all of the claims on appeal are
directed to patent-ineligible subject matter.
B. 35 U.S.C. § 103(a) over Wong, Griffin, Chappell, Kumar,
Khassawneh, and Tirodker
The Examiner finds Wong teaches “the use of IL-8 as a biomarker in
septic shock patients as an indicator of the likelihood of survival and for the
selection of appropriate treatment” including “pediatric patients (read as
encompassing infants)” (Ans. 13). The Examiner finds Griffin teaches
“sampling devices for measuring bacteria in blood culture in patients with
neonatal sepsis” and teaches “the inclusion of heart rate characteristics as a
correlative measure of clinical signs of illness and abnormal laboratory
tests” {Id. at 14). The Examiner finds Chappell teaches “analyzing the
10
Appeal 2017-001073
Application 13/695,243
quantitative levels [of cytokines] in one or more computers . . . where a
higher level is taught as being a prognostic indicator is disease” {Id. at 15).
The Examiner finds Kumar teaches “measuring TNFa from the blood
of infants with sepsis. Comparisons of cytokine concentrations were made
using analysis of variance techniques employing log transformed data” (Ans.
15). The Examiner finds “[tjhreshold values were determined and correlated
with disease status” and a “computer processing device was used to interpret
the data” {Id.). The Examiner finds Khassawneh teaches “measuring IL-6,
CRP, and IgM in the blood of neonates with sepsis . . . Threshold values are
recited . . . One or more computer processing devices were utilized to
analyze the levels and data” {Id. at 16). The Examiner finds Tirodker
teaches “measuring fimgemia in neonatal ICU patients . . . using DNA
extraction and PCR . . . Threshold values were determined” (Id. at 16).
The Examiner finds it obvious “to produce a combinatorial system
that assesses both physiological components including hear[t] rate
characteristics, as taught by Griffin, and multiple biochemical substance
parameters taught by Wong, Chappell, Kumar, Khassawneh, and Tirodker”
because “the combination of devices, techniques, methodologies, assays,
biochemical substances, infective organisms, and scoring systems, would
have yielded nothing more than predictable results to one of ordinary skill in
the art” (Ans. 17).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that Wong, Griffin, Chappell, Kumar,
Khassawneh, and Tirodker render the system of claim 17 obvious?
11
Appeal 2017-001073
Application 13/695,243
Findings of Fact
1. Wong teaches the “instant invention relates generally to the use
of IL-8 as a biomarker in septic shock patients as an indicator of the
likelihood of survival” (Wong | 8).
2. Wong teaches “the use of IL-8 as a biomarker in pediatric
patients diagnosed with septic shock, wherein the biomarker is used for
patient stratification for purposes of determining the appropriate treatment
for septic shock” (Wong 113).
3. Wong teaches thresholds such as
individuals having levels of IL-8 protein less than about 220
pg/ml, are considered appropriate candidates for standard care.
Conversely, individuals having IL-8 levels greater than about
1000 pg/ml, or greater than about 1500 pg/ml may be
considered as candidates for active agents that have been
identified as efficacious for the treatment of septic shock in
trials using IL-8 levels as exclusion criteria, or for other higher
risk therapies.
(Wong 118).
4. Griffin teaches: “We prospectively recorded clinical signs and
respiratory support into a relational events database (Microsoft Access), and
laboratory results were available from an electronic archive” (Griffin 223,
col. 1).
5. Griffin teaches “For each we calculate SD, sample asymmetry
(the characteristic abnormality is increased asymmetry due to more
decelerations and fewer accelerations (13)) and sample entropy” (Griffin
223, col. 1).
12
Appeal 2017-001073
Application 13/695,243
6. Griffin teaches “an internally validated point score system
relevant to late-onset neonatal sepsis. We found that heart rate
characteristics (HRC) monitoring is correlated with this score, adds
independent information to it, and becomes abnormal before it, among
infants with clinical and proven neonatal sepsis” (Griffin 227, col. 1).
7. Griffin teaches: “While [HRC index] will not replace clinical
assessment by the physician, blood cultures or other laboratory tests, HRC
monitoring can add information to conventional measures in the early
diagnosis of neonatal sepsis” (Griffin 227, col. 1).
8. Chappell teaches “determining the level of [cytokine]
expression within the sample; comparing the cytokine expression with pre­
defined levels of one or more reference cytokines; and determining if a
patient has or will develop an inflammatory . . . disease state [that] may be
selected from . . . sepsis” (Chappell 110).
9. Chappell teaches the data is “filtered by a digital signal
processor before being sent to the PC computer for storage and analysis”
(Chappell 1328).
10. Kumar teaches: “Serum levels of TNF-a varied ... On
analyzing the geometric means of different categories of sepsis, the range
was from 47-59 pg/ml which suggests that levels at approximately 50 pg/ml
can be the cutoff for sepsis” (Kumar 440, col. 1).
11. Khassawneh teaches “CRP is a useful single marker with high
sensitivity and specificity in predicting neonatal Gram-negative sepsis . . .
CRP and IgM in combination can be used to better predict or exclude
neonatal Gram-negative infections” (Khassawneh 175, col. 1).
13
Appeal 2017-001073
Application 13/695,243
Principles of Law
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
Analysis
We adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art (Ans. 13—18; FF 1—11) and agree that the
claims are rendered obvious by Wong, Chappell, Kumar, Khassawneh, and
Tirodker. We address Appellants’ arguments below.
Appellants contend:
It remains unknown from this ground of rejection how the prior
art references are proposed to be combined, what features from
which reference are proposed to be combined with other
features from other references, for what alleged obvious
purpose, or how such unexplained and unknown combination
would allegedly have resulted in the claimed subject matter.
Consequently this ground of rejection is improper as a matter of
fact and law, and must be reversed based on this record.
(App. Br. 9; cf Reply Br. 7).
We find this argument unpersuasive. The Examiner clearly relies
upon the rationale that combining known components in known ways would
have been obvious (see Ans. 17). As applied to the present facts, Griffin
teaches both a measuring device configured to measure heart rate
characteristics of an infant (FF 4, 7) and a process of interpreting those
measurements to identify infants with higher risk of sepsis (FF 5—6). Griffin
directly suggests combining HRC monitoring with other laboratory tests (FF
7).
14
Appeal 2017-001073
Application 13/695,243
Wong, Chappell, and Kumar each teach sampling devices that sample
particular biological substances from infants (FF 1, 2, 8, 10) and a process of
interpreting those measurements against predefined criteria to identify
infants at risk of sepsis or septic shock (FF 3, 8, 10). Chappell also teaches
the well-known use of computers in analysis of data (FF 10).
Finally, Khassawneh teaches that some biochemical measurements
such as CRP may specifically identify sepsis caused by specific organisms,
Gram-negative bacteria (FF 11).
Thus, the ordinary artisan, interested in following Griffin’s suggestion
that “HRC monitoring can add information to conventional measures [such
as laboratory tests] in the early diagnosis of neonatal sepsis” (FF 7), would
have reasonably combined Griffin’s HRC index with the laboratory tests
disclosed by Wong, Chappell, Kumar, and Khassawneh in order to obtain
more accurate predictions of sepsis, as well as the organism specific
information taught by Khassawneh (FF 11). Moreover, it would have been
obvious to employ a computerized system and use “modem electronic
components in order to gain the commonly understood benefits of such
adaptation, such as . . . increased reliability, simplified operation, and
reduced cost.” Leapfrog Enterprises Inc. v. Fisher-Price Inc., 485 F.3d
1157, 1162 (Fed. Cir. 2007). In the absence of any secondary consideration
evidence, the combination of these known processes into a computerized
system would have been obvious.
We recognize, but find unpersuasive, Appellants’ separate discussion
of the Wong, Chappell, Kumar, Khassawneh, Tirodker, and Griffin
references (see App. Br. 9-13), but provide no arguments explaining why
15
Appeal 2017-001073
Application 13/695,243
the combination of teachings would have been unobvious. Prior art “must
be read, not in isolation, but for what it fairly teaches in combination with
the prior art as a whole.” In re Merck & Co., Inc., 800 F.2d 1091, 1097
(Fed. Cir. 1986).
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that
Wong, Griffin, Chappell, Kumar, Khassawneh, and Tirodker render the
system of claim 17 obvious.
SUMMARY
In summary, we affirm the rejection of claims 17—29 under 35 U.S.C.
§101 because the claimed invention is not directed to patent eligible subject
matter.
We affirm the rejection of claim 17 under 35 U.S.C. § 103(a) as
obvious over Wong, Griffin, Chappell, Kumar, Khassawneh, and Tirodker.
Claims 18—29 fall with claim 17.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
16