Ex Parte Schwaibold et al

Patent Trial and Appeal Board

Feb 5, 2018

11596616 (P.T.A.B. Feb. 5, 2018)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O.Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
11/596,616 08/21/2007 Matthias Schwaibold 6580-P50120 1086
13897 7590 (
Abel Law Group, LLP
8911 N. Capital of Texas Hwy
Bldg 4, Suite 4200
Austin, TX 78759
EXAMINER
WEARE, MEREDITH H
ART UNIT PAPER NUMBER
3735
NOTIFICATION DATE DELIVERY MODE
02/07/2018 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):
mail @ Abel-IP.com
hmuensterer @ abel-ip. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MATTHIAS SCHWAIBOLD,
BERNHARD SCHOLLER, and LUDGER GROTE
Appeal 2017-001563
Application 11/596,616
Technology Center 3700
Before JEFFREY N. FREDMAN, RYAN H. FLAX, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal1 under 35U.S.C. § 134 involving claims to a device
for determining the severity of a person’s illness. The Examiner rejected the
claims as lacking patent utility and as obvious. We have jurisdiction under
35 U.S.C. § 6(b). We affirm.
Statement of the Case
Background
“In many illnesses, including, for example, illnesses related to a
patient’s sleep, there are dependent relationships with cardiovascular
diseases” (Spec. 1). “Various measuring methods are already known for
1 Appellants identify the Real Party in Interest as Weinmann Gerate fur
Medizin GmbH & Co. KG (see App. Br. 3).
Appeal 2017-001563
Application 11/596,616
determining individual parameters related to the autonomic regulation of the
cardiovascular system” (id.). According to the Specification “no methods or
devices have been disclosed which relate to a comprehensive evaluation of
the measured values for comprehensive consideration of the individual
factors in the determination of the severity of the illness” (id. at 2).
The Claims
Claims 39-64 and 69-77 are on appeal. Independent claim 39 is
representative and reads as follows:
39. A device for determining the severity of a person’s
illness, wherein the device comprises:
(a) a single sensor, the single sensor being a sensor for a
noninvasive measurement of at least one signal that is
dependent on the autonomic regulation of the cardiovascular
system of the person, which sensor is operative to acquire the at
least one signal using photoplethysmography;
(b) an evaluation device comprising (i) a calculation unit
for converting the at least one signal provided by the sensor into
a state parameter including oxygen saturation of the person’s
blood and amplitude variation of the oxygen saturation over
time; (ii) an index-determining device for calculating the
number of oxygen saturation amplitude drops per hour as a first
index and the time during which oxygen saturation amplitude
values are above a predetermined value as a second index; and
(iii) a comparison device that analyzes the first index and the
second index by taking into consideration at least one additional
parameter including one or more of age, weight, sex, case
history and medication of the person to provide a value that is
characteristic of the severity of the person’s illness; and
(c) an output device for the characteristic value provided
by the comparison device.
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The Issues
A. The Examiner rejected claims 39-53, 55—63, and 69-76 under 35
U.S.C. § 103(a) as obvious over Magalang2 and Westbrook3 (Final Act. 4—
18).
B. The Examiner rejected claims 54, 64, and 77 under 35 U.S.C. § 103(a)
as obvious over Magalang, Westbrook, and Massad4 (Final Act. 18—19).
C. The Examiner rejected claims 39-64 and 69-77 under 35 U.S.C.
§ 101 as lacking patentable subject matter (Final Act. 2—3).
A. 35 U.S.C. § 103(a) over Magalang and Westbrook
The Examiner finds Magalang teaches a pulse oximeter sensor and
calculating device as claimed (see Final Act. 5—6), but “does not teach the
index-determining device calculates the second index based on the time
during which oxygen saturation amplitude values are above the
predetermined value or limit” (id. at 6) and does not teach “taking into
consideration at least one additional parameter including one or more of age,
weight, sex, case history and medication of the person to provide a value that
is characteristic of the severity of the person’s illness” (id. at 7).
The Examiner identifies two alternative teachings to suggest the
second index of the index-determining device. The Examiner first finds
“Magalang discloses the calculation comprises determining the time as a
proportion of total recording time” (Final Act. 6) and therefore the ordinary
2 Magalang et al., Prediction of the Apnea-Hyp opnea Index From Overnight
Pulse Oximetry, 124 CHEST 169^U1701 (2003).
3 Westbrook et al., WO 02/065901 A2, published Aug. 29, 2002.
4 Massad, US 2004/0077934 Al, published Apr. 22, 2004.
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artisan “would recognize that the proportion calculated by Magalang could
alternatively be calculated from the cumulative time during which oxygen
saturation amplitude values are above the predetermined percentage value by
determining said time as a proportion of total recording time and subtracting
the proportion from the whole” (id.).
The Examiner, in addition, finds Westbrook teaches a pulse oximeter
system with a calculation unit that measures “the time during which the
oxygen saturation amplitude values are above a predetermined value as a
second index” (Final Act. 7). The Examiner finds it would have been
obvious to “modify the device/method of Magalang with calculating the
time during which oxygen saturation amplitude values are above a
predetermined value as an alternative or additional index as taught by
Westbrook in order to classify desaturation occurrences into desaturation
types, which may be utilized in clinical diagnosis of apnea risk” (id.).
The Examiner also finds Westbrook teaches “taking into consideration
at least one additional parameter including age, weight, sex and case history
of the person to provide a value that is characteristic of the severity of the
person’s sleep apnea” (Final Act. 8). The Examiner finds it would have
been obvious to “further modify the device/method of Magalang ... in order
to utilize the patient’s prior probability of risk for obstructive sleep apnea
(e.g., based on the additional parameters) and provide a determination of an
overall risk for OSA” (id. at 8—9).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that Magalang and Westbrook
render claim 39 obvious?
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Findings of Fact
1. Magalang teaches “obstructive sleep apnea (OSA) syndrome is
a major health problem affecting 2 to 4% of the middle-aged population . . .
Several quantitative indexes derived from overnight pulse oximetry have
been used to predict the presence of OSA” (Magalang 1694, col. 1 to 1695,
col. 1).
2. Magalang teaches: “Pulse oximetry data were collected as part
of the polysomnography . . . The oximeters in both sleep laboratories
employed a moving average of 3 [seconds]” {Id. at 1695, col. 2).
3. Magalang teaches the “oximetry data were then extracted from
the computerized polysomnography system for further off-line analysis.
Oximetry data were averaged over 2-s sampling intervals” (Id. at 1695, col.
2 to 1696, col. 1).
4. Magalang teaches “criteria for an event were a decrease of at
least the set amount (2%, 3%, or 4%) in oxygen saturation from the initial
data value for at least 10 s” (Id. at 1696, col. 1).
5. Magalang teaches a “A index was calculated as the average of
absolute differences of oxygen saturation between successive 12-s intervals
(sum of the absolute differences between two successive points, divided by
the number of intervals measured). The index quantifies oxygen saturation
variability” (Id. at 1696, col. 1 (citation omitted)).
6. Magalang teaches “10 indexes were calculated for each patient
in the derivation group using a computer program: A index, number of
desaturation events (to 2%, 3%, and 4% levels) per hour of recording time,
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and the cumulative time spent below 90%, 88%, 86%, 84%, 82%, and 80%
saturation as a proportion of total recording time” {Id. at 1696, col. 1).
7. Magalang teaches:
We used modem multivariate regression techniques to
develop a prediction model of the AHI [apnea-hypopnea index]
from the calculated quantitative indexes with commercially
available software . . . The various indexes of overnight
oximetry correlated with each other. As a result, we anticipated
that the models may be unstable and that the stmcture of the
model would depend heavily on the cases used in the derivation
set. To address this issue, we used one of a new group of
techniques (“committee of experts”) that used the aggregated
result from 20 different models. Details of the approach that we
used are provided in the appendix. The prediction model was
validated in two independent facilities so that it could be used
as a predictive instmment.
{Id. at 1696, col. 1 (citations omitted)).
8. Magalang teaches an “oximeter can be sent home with the
patient, and after the overnight recording mailed back to the sleep laboratory
or physician’s office for downloading of the data and a computer-generated
report of the predicted AHI with its 95% Cl reported back to the physician
through an automated system” {Id. at 1700, col. 1).
9. Magalang teaches, regarding “Clinical Applicability and
Controversy”, the “fact that our prediction was validated in two independent
sleep laboratories suggests that the model could be potentially applied
widely, although its impact on clinical practice has yet to be established” {Id.
at 1699, col. 2). Magalang concludes: “We have developed a novel
prediction model of the AHI using a combination of these quantitative
oximetry indexes with a better precision compared to using a single index.
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We validated this improved prediction in two independent sleep clinics
prospectively” (Id. at 1700, col. 1).
10. Figure 1 of Westbrook is reproduced below:
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“As indicated in Fig. 1, the preferred embodiment includes an Apnea Risk
Evaluation System (ARES) questionnaire that is filled out by a sleep study
patient” (Westbrook 15:7—8).
11. Westbrook teaches the
Apnea Risk Evaluation System (ARES) constructed in
accordance with the present invention is an integrated system to
assess the level of risk for SA [sleep apnea]. Components of
the system, including: (a) the physiological monitor that can be
easily self-applied to the forehead and comfortably worn
throughout the night to collect full-disclosure physiological
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recordings, (b) software which classifies types of respiratory
events, and (c) a questionnaire and analysis (ARES Profile
Analysis) which establishes an individual’s prior probability of
being at risk for SA, have been previously discussed. The
expert system integrates outputs from these components in
combination with a database of healthy subjects and patients in
order to classify levels of risk for SA and generate a result
report.
(Id. at 46:4—13).
12. Westbrook teaches”
To improve the accuracy of the system 10, a method was
developed for quantifying pre-existing risk factors for SA and
assigning a prior probability of sleep apnea 18 that can be
combined with the results from the physiological data into an
integrated multi-variate classification model.
The analysis of pre-existing risk factors for SA includes,
but is not limited to, responses to demographic, life-style and
quality of life questions, including age, gender, body mass
index (BMI), neck circumference, frequency and manifestation
of excessive daytime sleepiness, frequency and magnitude of
snoring, observed apneas, history of hypertension and use of
alcohol.
(Id. at 43:12 to 44:5).
13. Westbrook teaches a “physiological monitoring system 12 is
shown as including a low-powered lightweight monitor device 30 that
incorporates the necessary pulse oximetry (Sp02) sensor components, such
as sensors, amplifiers, filtering, and the like” (Id. at 17:11—13).
14. Westbrook teaches the “process of measuring oxyhemoglobin
saturation in accordance with the present invention, after data has been
collected, follows generally accepted [principles]” (Id. at 29:12—13).
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15. Westbrook teaches that after data collection “additional
techniques were empirically derived in order to classify the desaturations
into types. In the present preferred embodiment, a DEI type is defined as a
desaturation occurrence that has a high probability of being due to an
obstructive sleep apnea or hypopnea” (Id. at 37:2—5).
16. Westbrook teaches:
First, the slope of the DEI resaturation is quite steep. For
example, a DEI is classified when the nadir is >= 86%, and at
least a 3.8% recovery is detected in <= 6 seconds from the nadir
to the point of maximum resaturation. . . . Second, the slope of
the desaturation must decline steadily from the point of peak
saturation.
(Id. at 37:9-16).
17. Westbrook also teaches:
computation of the: (a) total number of respiratory events (by
and across types) across positions per hour of recording and
over entire recording session and by position per hour of
recording and over entire session; (b) average number of
respiratory events (by and across types) per hour of recording
time (RDI) across and by position over the entire session; and
(c) number of 5-minute blocks of time with snoring void of
respiratory events across and by position over the entire
session.
(Id. at 46:15-20).
Principles of Law
The Examiner has the initial burden of establishing a prima facie case
of obviousness under 35 U.S.C. § 103. In re Oetiker, 977 F.2d 1443, 1445
(Fed. Cir. 1992). “The combination of familiar elements according to
known methods is likely to be obvious when it does no more than yield
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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 (Final Act. 4—18; FF 1—17) and agree that
the claims are obvious over Magalang and Westbrook. We address
Appellants arguments below.
Appellants contend:
the objective of the study described in MAGAFANG clearly is
not to obtain any information relating to the health or illness of
an individual patient, let alone the severity of an individual
patient’s illness. For this reason alone, one of ordinary skill in
the art would not be motivated to combine the disclosure of
MAGAFANG with the disclosure of WESTBROOK, which is
concerned with the evaluation of individual patients.
(App. Br. 14—15). Appellants contend Magalang’s “study was to find out,
based on a statistical analysis of data obtained from several hundred patients,
whether the (mere) presence or absence of AHI can reliably be determined
by using data obtained by simple pulse oximetry instead of (much more
burdensome and complicated) standard overnight polysomnography” (Id. at
16-17).
We find these arguments unpersuasive because Magalang expressly
considers clinical applicability of the device by suggesting “the model could
be potentially applied widely” to patients (FF 9), specifically providing the
example of an oximeter “sent home with the patient. . . and a computer
generated report of the predicted AHI [apnea-hypopnea index]. . . reported
back to the physician through an automated system” (FF 8). This direct
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suggestion to apply Magalang’s apnea indices to clinical practice with a
determination of the severity of illness as predicted by the apnea-hypopnea
index for a specific patient provides the ordinary artisan with a reason to
combine Magalang’s device with Westbrook’s patient-centered apnea risk
evaluation system (FF 10—12). We therefore agree with the Examiner that
“Magalang not only teaches calculating a predicted AHI... for each
individual patient involved in the study, but also suggests calculating this
predicted AHI for subsequent individuals as a simpler, less expensive and
cumbersome alternative to overnight PSG” (Ans. 6).
Appellants contend “one of ordinary skill in the art will readily
recognize that within the framework of the study reported in MAGALANG
it would not serve any useful purpose to additionally consider any parameter
relating to age, weight, etc. of any or all individual patients which
participated in the study” (App. Br. 17).
We find this argument unpersuasive because it fails to address the
teachings of Magalang and Westbrook in combination. It is the combination
of Magalang and Westbrook that renders claim 39 obvious, not the teachings
of Magalang alone. As the Examiner notes “Magalang expressly suggests
utilizing the predicted AHI calculation for individuals in place of PSG . . .
Similarly, Westbrook discloses consideration of additional patient
parameters (e.g., age, weight, sex, etc.) in addition to an AHI value in an
expert system to accurately classify levels of risk for sleep apnea” (Ans. 7;
cf. FF 1-17).
Moreover, Westbrook specifically teaches to “improve the accuracy
of the system 10, a method was developed for quantifying pre-existing risk
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factors for [sleep apnea] and assigning a prior probability of sleep apnea 18
that can be combined with the results from the physiological data into an
integrated multi-variate classification model” (FF 12). Westbrook teaches
pre-existing risk factors for sleep apnea include age, gender, body mass
index (BMI) (see FF 12). Thus, Westbrook directly suggests that factors
such as age, gender, and weight are useful to improve the accuracy of
classification models, such as the model of Magalang, for proper diagnosis
of sleep apnea. “Non-obviousness cannot be established by attacking
references individually where the rejection is based upon the teachings of a
combination of references.” In re Merck & Co., 800 F.2d 1091, 1097 (Fed.
Cir. 1986).
Appellants contend:
considering the preliminary nature of the findings reported in
MAGALANG, it is only with hindsight that one can conclude
that a person of ordinary skill in the art would be motivated to
further develop the method disclosed therein (or a similar one),
let alone to additionally take into account patient-specific
information such as age, weight, etc. in order to assess the
severity of OSA in an individual patient.
(App. Br. 18).
We find this argument unpersuasive. While we are fully aware that
hindsight bias must be avoided in determinations of obviousness, Graham v.
John Deere Co., 383 U.S. 1,36 (1966), we are also mindful that the
Supreme Court has clearly stated that the “combination of familiar elements
according to known methods is likely to be obvious when it does no more
than yield predictable results.” KSR, 550 U.S. at 416. Here, improper
hindsight reasoning was not required.
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As already discussed, Magalang teaches a “prediction model of the
AHI using a combination of these quantitative oximetry indexes with a
better precision compared to using a single index” (FF 9). Moreover,
Magalang concludes: “We validated this improved prediction in two
independent sleep clinics prospectively” (FF 9). The ordinary artisan,
interested in improving ease and accuracy of sleep apnea diagnosis, would
have had reason to combine the improved prediction indexes of Magalang
with the risk factors of Westbrook because Westbrook teaches inclusion of
these risk factors further improves diagnosis accuracy (FF 12). Given the
express teachings in both Magalang and Westbrook that these factors and
indexes improve diagnosis when combined with physiological oximetry
data, we agree with the Examiner that the ordinary artisan would have had
reason to “utilize or ‘further develop’ the overnight pulse oximetry
techniques disclosed by Magalang” (Ans. 8) by incorporating the improved
factors of Westbrook (FF 12).
Appellants contend “one of ordinary skill in the art would conclude
that pulse oximetry is not even useful for detecting mild to moderate OSA.
This would make it impossible to determine the severity of OSA even if
additional patient-specific patient information were available” (App. Br. 18).
We find this expectation of success argument unpersuasive because
Magalang specifically teaches a “prediction model of the AHI using a
combination of these quantitative oximetry indexes with a better precision”
(FF 9), while Westbrook teaches accuracy can be improved by combining
pre-existing risk factors for sleep apnea with physiological data (FF 11—12).
Appellants provide no evidence that the combined techniques of Magalang
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and Westbrook would not reliably provide predictive information regarding
the risk of sleep apnea. “Obviousness does not require absolute
predictability of success . . . all that is required is a reasonable expectation
of success.” In re Kubin, 561 F.3d 1351, 1360 (Fed. Cir. 2009).
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that
Magalang and Westbrook render claim 39 obvious.
B. 35 U.S.C. § 103(a) over Magalang, Westbrook, and Mass ad
Appellants do not separately argue this obviousness rejection, instead
relying upon their arguments to overcome the combination of Magalang and
Westbrook. The Examiner provides sound, fact-based reasoning for
combining Massad with these references (see Final Act. 18—19). Having
affirmed the obviousness rejection of claim 39 over Magalang and
Westbrook for the reasons given above, we also conclude that the further
combination with Massad renders the rejected claims obvious for the reasons
given by the Examiner.
C. 35 U.S.C. §101
The Examiner finds all of the claims on appeal unpatentable under 35
U.S.C. § 101 as being directed to patent-ineligible subject matter,
specifically “the abstract idea of comparing new patient data and stored
information and using categorization rules to categorize the patient data
based on severity of an illness” (Final Act. 2—3). The Examiner finds the
device claim elements in claim 39 and the method steps in claim 45 “are
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recited at a high level of generality that append well-understood, routine and
conventional activities to the judicial exception and are used only for data
gathering, therefore representing only insignificant extra-solution activity”
{id. at 3). The Examiner concludes “the claims do not include additional
elements that are sufficient to amount to significantly more than the judicial
exception” {id. at 3).
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 a patent ineligible concept, such as an abstract idea or law of
nature. Alice Corp. Pty. Ltd. v. CLSBankInt’l, 134 S.Ct. 2347, 2355
(2014); Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566
U.S. 66, 75—77 (2012); Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d
1371, 1375 (Fed. Cir. 2015). While both device and method claims are
generally eligible subject matter, device and method claims that are directed
only to abstract ideas and/or natural phenomena are directed to a patent
ineligible concept. Ariosa, 788 F.3d at 1376.
Alice Step One
Claim 39 of the instant application is directed to a device for
determining illness severity based on blood oxygen levels with other
personal parameters. Claim 45 is a method incorporating the device of claim
39. The device and related process are directed to both a law of nature and
an abstract idea. In particular, the law of nature/natural phenomenon is the
relationship between parameters including blood oxygen levels, age, weight,
sex, etc. and severity of apnea. Cf. Mayo, 566 U.S. at 77 (“[Fjaws of
nature—namely, relationships between concentrations of certain metabolites
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in the blood and the likelihood that a dosage of a thiopurine drug will prove
ineffective or cause harm.”). That the relationship is obtained using a blood
oxygen measuring device and computer processing of the test history data
does not change the fact that the relationship between apnea severity and
natural phenomenon such as sleeping blood oxygen levels and age, weight,
or sex “exists in principle apart from any human action.” Mayo, 566 U.S. at
77.
In addition, the recited “calculation unit,” “index-determining device,”
and “comparison device” all involve categorizing and/or analyzing
information. Our reviewing Court has explained that “[information as such
is an intangible” and “that collecting information, including when limited to
particular content (which does not change its character as information),”
analyzing it, and presenting the results of the collection and analysis without
more are patent ineligible abstract concepts. See, e.g., Electric Power
Group, LLCv. Alstom S.A., 830 F.3d 1350, 1353-54 (Fed. Cir. 2016).
Because the claims are directed to an abstract idea/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 (quoting 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.
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We are not persuaded by Appellants’ argument that “the Examiner has
not provided any evidence which would show that all of the activities recited
in the instant claims are ‘conventional activities previously known to the
pertinent industry’” (App. Br. 10).
As evidenced by our affirmance of the obviousness rejection above,
we find that Magalang and Westbrook teach all of the elements required for
claim 39, including the use of device with a sensor for measurement of
blood oxygen levels (FF 2, 13, 14), a computer that analyzes the blood
oxygen level to create an indexes of the oxygen levels above and below
specific values (FF 3—7, 15—17) and includes comparisons of additional
parameters such as age and weight (FF 10-12), and outputs the final
information to a physician (FF 8).
Our conclusion that these elements are routine and conventionally
used is buttressed by the absence of any disclosure in Appellants’
Specification that recites any specific novel details for the sensor, the
calculation unit, the index determining device, the comparison device, or the
output device (see, e.g., Spec. 11—13).
In sum, the evidence of record supports the Examiner’s position that
the claims do not add something “significantly more” to the abstract idea
and/or law of nature. Instead, each of the steps in the claims “are
conventional, routine, and well-known. They involve the normal, basic
functions of a computer.” Versata Development Group, Inc. v. SAP
America, Inc., 793 F.3d 1306, 1335 (Fed. Cir. 2015).
In order for the addition of a machine to impose a meaningful
limit on the scope of a claim, it must play a significant part in
permitting the claimed method to be performed, rather than
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function solely as an obvious mechanism for permitting a
solution to be achieved more quickly, i.e., through the
utilization of a computer for performing calculations.
SiRF Tech., Inc. v. Int’l Trade Comm’n, 601 F.3d 1319, 1333 (Fed. Cir.
2010).
We conclude that the practice of the device or method claims does not
result in an inventive concept that transforms the abstract idea/natural
phenomena of determining illness severity based on blood oxygen levels
with other personal parameters for a patient 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,” literally or figuratively. Mayo, 566 U.S. at 72;
Ariosa, 788 F.3d at 1377.
Appellants contend the “rejection consists merely of boilerplate
assertions, without any explanation and/or supporting evidence, let alone a
detailed analysis” (App. Br. 9).
We are not persuaded because the Examiner properly identified the
natural law and abstract idea (see Final Act. 2—3) and recognized that all of
the remaining elements do not add significantly more, particularly as shown
by the teachings of Magalang and Westbrook in the obviousness rejection
(see Final Act. 4—19).
Appellants contend the “Examiner has failed to identify a concept that
the courts have identified as an abstract idea and is similar to the concept
reflected in the instant claims, which is yet another reason why the instant
rejection is without merit” (App. Br. 11).
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We find this argument unpersuasive because the Examiner directly
compared the facts to those in SmartGene, Inc. v. Advanced Biological
Laboratories, SA, 555 Fed. Appx. 950, 955 (Fed. Cir. 2014) (see Final Act.
2021). In SmartGene, the claims were directed towards selection of a
treatment regimen by using a computer with knowledge bases and expert
rules to create a ranked list of treatments and advisory information.
SmartGene, 555 Fed. Appx. at 952. Just as in SmartGene, the current claim
39 “does not purport to identity new computer hardware: it assumes the
availability of physical components for input, memory, look-up, comparison,
and output. Nor does it purport to identity any steps beyond those which
doctors routinely and consciously perform.” Id. at 955. That is, neither
claim 39 nor the Specification identity any new sensor, computer, or output
device. Nor does the claim demonstrate that the indexes, which are simply
computerized analysis of data ordinarily reviewed by physicians, represent
anything beyond that already demonstrated as known by Magalang and
Westbrook (FF 1—17). In such a context SmartGene noted “the concern
about preempting public use of certain kinds of knowledge, emphasized in
Mayo, is a grave one.” SmartGene, 555 Fed. Appx. at 955.
Appellants contend:
The method of SmartGene further does not take into account
any patient-specific data (e.g., age, weight, etc.) and also does
not provide any information regarding a specific patient (e.g.,
the severity of the patient’s illness) but merely provides
“advisory information for one or more therapeutic treatment
regimens in said ranked listing based on said patient
information and said expert rules”. In other words, the method
of SmartGene is completely theoretical, i.e., can be carried out
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Application 11/596,616
even without an actual patient or can be carried out on a
hypothetical patient.
(App. Br. 12).
We find this argument unpersuasive because Appellants cite no
authority that a claim applying a method or device drawn to “determining”
or “evaluating” “the severity of a person’s illness” for a specific patient
renders the claim patent-eligible (see claims 39 and 45). The claim in
Smartgene clearly required an actual patient because the method was drawn
to “selection of a therapeutic treatment regimen for a patient with a known
disease.” SmartGene, 555 Fed. Appx. at 951. Similarly, in Mayo itself, the
claim was directed to measuring “the level of 6-thioguanine in said subject,”
a test of a sample from a specific patient, but the Supreme Court found the
claim “not sufficient to transform unpatentable natural correlations into
patentable applications.” Mayo, 566 U.S. at 74, 80.
Appellants contend that “[i]t is not seen that a corresponding device is
an abstract idea or not significantly more than an abstract idea” (App. Br.
13).
We find this argument unpersuasive because simply adding one or
more known apparatus to an abstract idea is insufficient because the
“Supreme Court and [the Federal Circuit] have repeatedly made clear that
merely limiting the field of use of the abstract idea to a particular existing
technological environment does not render the claims any less abstract.”
Affinity Labs of Texas, LLCv. DIRECTV, LLC, 838 F.3d 1253, 1259 (Fed.
Cir. 2016). The Court was likewise not persuaded by a Patent Owner’s
attempt “to distinguish its claims from those found to be abstract in Alice
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Appeal 2017-001563
Application 11/596,616
and other cases by showing that its claims require not only a computer but
also an additional machine—a scanner.” Content Extraction &
Transmission LLC v. Wells Fargo Bank, Nat’l Ass ’n, 776 F.3d 1343, 1347
(Fed. Cir. 2014). That is, simply because a claim is drawn to a device rather
than a method does not necessarily render the claim patent eligible.
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.
SUMMARY
In summary, we affirm the rejection of claim 39 under 35 U.S.C.
§ 103(a) as obvious over Magalang and Westbrook. Claims 40-53, 55—63,
and 69-76 fall with claim 39.
We affirm the rejection of claims 54, 64, and 77 under 35 U.S.C.
§ 103(a) as obvious over Magalang, Westbrook, and Massad.
We affirm the rejection of claims 39-64 and 69-77 under 35 U.S.C.
§ 101 as lacking patentable subject matter.
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
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