Ex Parte Brown

Patent Trial and Appeal Board

Apr 28, 2016

11359437 (P.T.A.B. Apr. 28, 2016)

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.
11/359,437 02/23/2006 Stephen James Brown 1576-1203 / 7553.00111 3996
60683 7590 04/29/2016
Robert Bosch Healthcare Systems, Inc.
2400 GENG ROAD, SUITE 200
PALO ALTO, CA 94303
EXAMINER
HARWARD, SOREN T
ART UNIT PAPER NUMBER
1631
MAIL DATE DELIVERY MODE
04/29/2016 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte STEPHEN JAMES BROWN1
__________

Appeal 2014-001267
Application 11/359,437
Technology Center 1600
__________

Before MELANIE L. McCOLLUM, TINA E. HULSE, and
JACQUELINE T. HARLOW, Administrative Patent Judges.

McCOLLUM, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to an
organization or monitoring method. The Examiner has rejected the claims
for obviousness, double patenting, and obviousness-type double patenting.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
STATEMENT OF THE CASE
Claims 30–59 are on appeal (Br. 1). Claim 30, 32, and 39 are
representative and are set forth in the Claims Appendix to Appellant’s
Appeal Brief (id. at 22–25).

1 Appellant identifies the real party in interest as Robert Bosch Healthcare
Systems, Inc. (Br. 2).
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Claims 30–59 stand rejected under 35 U.S.C. § 103(a) as obvious in
view of Evers et al. (US 5,558,638, Sept. 24, 1996) and Iliff (US 5,660,176,
Aug. 26, 1997) (Ans. 3).
Claims 30–59 stand provisionally rejected under 35 U.S.C. § 101 as
claiming the same invention as claims 1–20 of copending Application
No. 13/303,622 (Final Act. 7).
Claims 30–32, 37, 38, 49–51, 57, and 58 stand “rejected on the
ground of nonstatutory obviousness-type double patenting as being
unpatentable over (respectively) claims 35, 35, 35+23, 35, 35+39, 35, 35,
35+23, 35 and 35+39 of U.S. Patent No. 8,140,663” (id. at 8).
Claims 39, 44, 46, and 47 stand “provisionally rejected on the ground
of nonstatutory obviousness-type double patenting as being unpatentable
over claims 1, 4 and 5 of copending Application No. 13/408334” (id. at 9).
OBVIOUSNESS
The Examiner relies on Evers for teaching:
a method of monitoring and supporting a patient, comprising:
a. providing a patient with a “remote base unit” of RBU (i.e.
a programmable apparatus) . . . which is configured to be
associated with a single patient . . . ; once initialized with
patient information, the RBU is uniquely associated to that
patient . . . [, wherein t]he unit is provided as part of a
method “for monitoring ... a plurality of patients suffering
from a variety of medical conditions, risks or disease
states” . . .
b. creating “patient specific qualitative data questionnaires”
. . .
c. the base unit receives instructions from a care center server
. . . , including questionnaires . . . , and sets of queries and
responses are stored on the care center server . . .
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d. this base unit includes a user interface for displaying the
questions and receiving answers . . . , and an interface for
two-way communications with a server . . .
e. transmitting the patient data, including physiological data,
patient and device identification, to the server . . .
f. organizing the patient data in a database.
(Final Act. 3–4.) The Examiner finds that “Evers teaches that this
monitoring method, using a remote base unit, allows adequate medical care
to be provided at home at a lower cost than providing that care at a health
care institution” (id. at 4).
The Examiner relies on Iliff for teaching:
a. identifying a patient showing symptoms of a serious
medical condition . . . , and providing patients with a
computer system (i.e. a programmable apparatus) . . .
b. creating a list of conditions, including queries about
symptoms and responses for those conditions, that is
specific to the patient . . .
c. storing the list of conditions, screening questions and
responses in the system . . .
d. providing software to the user for use in their computer
system . . . , the software containing the list of conditions
and customized screening questions . . . , their computer
system having a user interface for displaying the
diagnostic queries and receiving the responses . . . , and a
modem — a two-way communication mechanism — for
receiving updates . . .
e. —
f. organizing responses to the diagnostic questions,
physiological data, and patient identification information
in a patient file database . . . that is stored on the computer
system.
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(Id. at 4–5.) The Examiner finds that “Iliff teaches that such a system
provides consistent, personalized advice to patients at low cost and at any
time” (id. at 5).
The Examiner concludes:
At the time of invention, said practitioner would have followed
the teaching of Iliff — that a questionnaire administered by a
computer includes predefined queries and responses regarding
symptoms and behaviors — and combined the questionnaire
containing predefined queries and responses of Iliff with the
medical monitoring system of Evers, which includes
administering personalized questionnaires as part of its
monitoring. Given the similarities of the systems of Evers and
Iliff, and their common function of using electronic devices to
provide medical care to a patient at home, said practitioner would
have readily predicted that the combination would result in
methods of obtaining, organizing and analyzing medical data
from a group of patients using remotely programmable
apparatuses.
(Id. at 6.)
Findings of Fact
1. Evers discloses “a system for monitoring the health and medical
requirements of a plurality of patients suffering from a variety of medical
conditions, risks or disease states from a remote location” (Evers, col. 2,
ll. 38–41).
2. In particular, Evers discloses “a patient monitor and support
system . . . includ[ing] a number of patient sites . . . , which are individually
connected via a set of communications links . . . to a care center 600,”
wherein a “subsystem at each of the patient sites 100 has control and data
acquisition capabilities and may be configured to automatically transfer
patient communications and data to the care center 600 and to receive
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nursing communications, instructions and prompts from the care center 600”
(id. at col. 4, ll. 8–19).
3. Evers also discloses that the “data received . . . is ultimately
stored in the patient database computer” (id. at col. 4, ll. 37–38).
4. In addition, Evers discloses:
The subsystem is controlled by a remote base unit 150 which can
down load from the care center 600 computer Patient
Identification and Operating files to the base unit 150 in the home
initialization and operating protocol files specific to that
particular patient. Examples of these files include: medication
schedules, blood pressure protocols, patient identification data,
patient logistical data, parameter thresholds, auto dial phone
numbers and schedules, call-in schedule, infusion pump settings
and patient specific qualitative data questionnaires (relating to
her present progress).
(Id. at col. 29, ll. 15–25.)
5. Evers also discloses:
Activity Icons displayed across the top of the screen are used to
initiate the tests. . . . Pressing the Questionnaire Icon . . . invokes
the Questionnaire Menu . . . . Once in the Questionnaire Menu,
the user first selects the type of Questionnaire he wants to
respond to . . . . He then answers each question . . . and may
return to the Questionnaire Menu . . . to answer more questions.
(Id. at col. 26, ll. 23–48.)
6. Evers exemplifies the following questionnaire:

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(Id. at col. 28, ll. 19–30.)
7. Iliff discloses “a computerized medical diagnostic and
treatment advice (MDATA) system that is a medical knowledge-based
system designed to give medical advice to the general public over the
telephone network” (Iliff, col. 2, ll. 59–63).
8. Iliff also discloses that the “computer-driven dialogue consists
of simple yes/no and multiple choice questions” (id. at col. 7, ll. 21–23).
9. In addition, Iliff discloses:
The MDATA system’s statistic generating capabilities enable the
system to analyze the effectiveness of the questions used in the
diagnostic process. As a result, physicians benefit from the
immense amount of statistical information that is gathered
regarding the wording of questions asked in taking medical
histories. For example, exactly what percentage of patients who
answer “yes” to the question, “Is this the worst headache of your
life?” actually have a subarachnoid hemorrhage? Although this
is a classic description of this problem, the exact probability of
having this kind of brain hemorrhage after answering “yes” to
this question is not presently known.
(Id. at col. 12, ll. 37–49.)
10. Iliff also discloses that, “[a]fter the initial screening questions
. . . are completed and a medical record . . . has been opened, the MDATA
system 100 asks the patient to describe the complaint” (id. at col. 35, ll. 31–
35).
11. In particular, Iliff discloses:
The easiest and most frequently used way to identify the
complaint is by anatomic system, i.e., “what system is your
problem in?” Anatomic system 472 refers to basic body systems
such as cardiovascular, respiratory, nervous system, digestive,
ear/nose/throat, ophthalmology, gynecology/ obstetrics, urology,
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blood/hematology, skin, and endocrine. After the patient has
identified the anatomic system of their complaint, they are asked
a series of “System Screening Questions” . . . . For each anatomic
system, there are some symptoms or combinations of symptoms
that, if present, would mandate immediate intervention, such that
any delay, even to go any further through the menuing process,
could cause harm. For example, if the patient has identified the
cardiovascular system as the anatomic system in which his or her
complaint lies (i.e., chest pain), the MDATA system 100 will ask
the cardiovascular system screening questions. For example, the
patient would be asked, “Do you have both pressure in your chest
and shortness of breath?[”] If these symptoms are present
together, immediate intervention is necessary. . . .
Therefore, . . . the system 100 determines if a serious
medical condition exists. If so, the system 100 . . . plays a
message that advises the patient to seek immediate medical
attention and ends the evaluation process . . . . If it is determined
. . . that a serious medical condition does not exist, the
system 100 proceeds to a complaint menu . . . and recites a list of
algorithms dealing with the problem that corresponds to the
anatomic system selected. The patient then selects an algorithm
from the list.
If the patient is not sure of the anatomic system, the
system 100 attempts to identify the problem by requesting the
cause. Cause 476 refers to a cause for an illness or disease such
as trauma, infection, allergy/immune, poisoning, environmental,
vascular, mental, genetic, endocrine/metabolic, and tumor. Once
the patient has identified what they think is the cause of their
problem (e.g., trauma, infection), the MDATA system 100 asks
the “Cause Screening Questions” . . . . These questions are asked
to make sure that the patient is not suffering from an immediate
life-threatening problem. . . . If it is determined . . . that a serious
medical condition does not exist, the system 100 proceeds to a
complaint menu . . . and recites a list of algorithms dealing with
the problem that corresponds to the cause selected. The patient
then selects an algorithm from the list.
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(Id. at col. 35, l. 45, to col. 36, l. 35.)
12. As an example, Iliff discloses:
During the evaluation process 254, the MDATA
system 100 asks the patient a series of “diagnostic screening
questions.” From the answers to these questions, along with any
physical signs elicited from the patient . . . , under the direction
of the MDATA system 100, the system establishes the most
likely cause of the patient’s headache.
The following are examples of diagnostic screening ques-
tions for headache:
■ DO YOU EXPERIENCE MORE THAN ONE KIND OF
HEADACHE?
■ DO YOU, OR DOES ANYONE ELSE, KNOW THAT
YOU ARE GOING TO GET A HEADACHE BEFORE
THE ACTUAL PAIN BEGINS?
■ DO YOUR HEADACHES FREQUENTLY WAKE YOU
UP AT NIGHT?
■ DO YOUR HEADACHES USUALLY BEGIN SUD-
DENLY?
Based upon the answers to the diagnostic screening
questions, the MDATA system 100 reorders the first list. The
list then becomes a list of the possible causes of headache in
decreasing levels of probability in the patient seeking
consultation. The first list is now patient specific. If the
MDATA system 100 concludes that migraine is the most likely
cause of the patient’s headache, then migraine will now be
ranked at the top of the first list.
. . . After reordering the first list and placing migraine at
the top, the MDATA system 100 then asks several questions
related specifically to migraine headaches. These are called the
“migraine screening questions.” The probability that the patient
actually has a migraine headache is calculated from the answers
to these questions. . . .
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The following are examples of migraine screening ques-
tions:
■ IS EITHER NAUSEA OR VOMITING ASSOCIATED
WITH YOUR HEADACHE?
■ ARE VISUAL DISTURBANCES ASSOCIATED WITH
YOUR HEADACHE?
(Id. at col. 39, l. 38, to col. 40, l. 15.)
13. Iliff also discloses:
Another way in which the MDATA system is modifiable
is in its use of global sensitivity/selectivity factors. As with every
decision, there is always a balance to be achieved between risk
and benefit, and so with the MDATA system 100. One of the
questions the MDATA system 100 tries to answer is whether the
patient needs to be seen immediately by a physician. This leads
to this discussion about sensitivity and selectivity.
Sensitivity and selectivity are statistical terms that refer to
how accurately a decision can be made. In this case, sensitivity
refers to the number of patients which the MDATA system 100
did not think needed to be seen by a physician but that actually
did.
If the program were to be so sensitive that no disease
process that eventually required meaningful physician inter-
vention would be treated at home (no false negatives), then every
single complaint would necessitate a visit to the doctor, which is
a useless system. On the other hand, too selective a system (no
false positives) i.e., no unnecessary visits to the doctor’s office,
would necessitate that an attempt be made at home treatment for
every complaint, which is a useless and dangerous system.
So again, a balance must be reached between these two
ends of the spectrum. To achieve this, the sensitivity/ selectivity
ratio of the entire MDATA system 100 can be changed by setting
or tuning a plurality of sensitivity factors. These sensitivity
factors affect the following functions: meta thresholds, reenter
horizon threshold, frequency of call back, symptom-severity
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filters, sequential slope filters, exponential symptom-severity
filters, and probabilities of diagnoses in the treatment table. In
addition, as in the headache example, the scoring of the screening
questions already weighted is modulated or modified by the
sensitivity factors.
(Id. at col. 60, ll. 21–53.)
14. In addition, Iliff discloses:
A second embodiment of the MDATA system entails a major
shift of how the questions and responses are delivered to the
patient. Rather than the use of a telephone, the voice processing
and voice response technology, the system software is published
via media such as floppy disks, CD ROM, or PCMCIA cards for
use on a patient’s personal computer.
(Id. at col. 65, ll. 20–25.)
Analysis
In view of the foregoing findings of fact (FF), we conclude that the
Examiner has set forth a prima facie case that the method of representative
claim 30 would have been obvious.
Appellant argues, however, that the “Examiner has failed . . . to allege
that either Evers or Iliff discloses transmitting a computer program which
includes predefined responses to a customized query” (Br. 9). We are not
persuaded.
Evers discloses “a system for monitoring the health and medical
requirements of a plurality of patients . . . from a remote location” (FF 1). In
particular, Evers discloses that “patient specific qualitative data
questionnaires” can be downloaded to a remote base unit from a care center
computer (FF 4 (emphasis added)). Evers also discloses: “Pressing the
Questionnaire Icon . . . invokes the Questionnaire Menu . . . . Once in the
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Questionnaire Menu, the user first selects the type of Questionnaire he wants
to respond to . . . . He then answers each question.” (FF 5.) In addition, as
noted by the Examiner (Ans. 4), Evers exemplifies the following
questionnaire:

(FF 6.)
Iliff discloses “a computerized medical diagnostic and treatment
advice (MDATA) system that is a medical knowledge-based system
designed to give medical advice to the general public over the telephone
network” (FF 7). Iliff also discloses that the “computer-driven dialogue
consists of simple yes/no and multiple choice questions” (FF 8). In addition,
Iliff discloses:
A second embodiment of the MDATA system entails a major
shift of how the questions and responses are delivered to the
patient. Rather than the use of a telephone, the voice processing
and voice response technology, the system software is published
via media such as floppy disks, CD ROM, or PCMCIA cards for
use on a patient’s personal computer.
(FF 14 (emphasis added).) Based on these disclosures, we agree with the
Examiner that it would have been obvious to transmit a computer program
that includes predefined responses to a customized query (Ans. 3–5).
Appellant also argues that “the Examiner has failed to allege that
either Evers or Iliff discloses selecting individuals with a risk factor for a
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disease for monitoring” (Br. 11). We are not persuaded. Instead, as noted
by the Examiner (Ans. 7), Evers specifically discloses “a system for
monitoring the health and medical requirements of a plurality of patients
suffering from a variety of medical conditions, risks or disease states” (FF 1
(emphasis added)).
In addition, Appellant argues that “the Examiner has failed to provide
a clear articulation explaining why one of ordinary skill in the art would find
the specialized system of Evers to be defective for its stated purpose, and
would therefore look to a diagnostic tool to correct the deficiencies in a
specialized monitoring system” (Br. 13). We are not persuaded.
The Examiner is relying on Iliff for teaching predefined response
choices regarding symptoms (Final Act. 4). As noted by Appellant, there are
differences between Evers and Iliff (Br. 11–12). However, as noted by the
Examiner, both references relate to “using electronic devices to provide
medical care to a patient at home” (Final Act. 6). Given their similarities,
and to the extent that Evers does not teach predefined response choices
regarding symptoms (see FF 6), we conclude that Appellant has not
adequately explained why it would not have been obvious, based on Iliff, to
include them.
With regard to claim 32, Appellant additionally argues that “the
combination proposed by the Examiner fails to arrive at the invention of
[this] claim” (Br. 14). We are not persuaded.
As noted by the Examiner (Final Act. 5), Evers discloses that a
“subsystem is controlled by a remote base unit 150 which can down load
from the care center 600 computer Patient Identification and Operating files
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to the base unit 150 in the home initialization and operating protocol files
specific to that particular patient,” these files including “patient specific
qualitative data questionnaires (relating to her present progress)” (FF 4). In
addition, Iliff discloses asking new queries based upon receiving responses
to other queries (FF 11–12). Thus, we agree with the Examiner that it would
have been obvious to transmit new queries from Evers’ care center to a
remote base unit based upon receiving responses from the individual
associated with that base unit (Final Act. 5).
We agree with Appellant that a “‘questionnaire’ is not a response
choice” (Br. 14). However, as discussed above, we conclude that Evers and
Iliff suggest predefined response choices (FF 6, 8, & 14).
With regard to claim 39, Appellant additionally argues that Iliff does
not disclose distinguishing a group of individuals having “similar symptoms,
behavioral or environmental profiles” or “any further categorization of the
distinguished individuals” (Br. 16). We are not persuaded.
In rejecting claim 39, the Examiner finds: “Iliff teaches performing
statistical analysis of information gathered from the users . . . , and using that
statistical analysis to tune sensitivity and selectivity parameters to
distinguish between patients that need to see a physician immediately, and
those that do not (i.e. two different subgroups)” (Final Act. 5, citing Iliff,
col. 12, ll. 38–49, & col. 60, ll. 21–53 (FF 9 & 13)). In addition, the
Examiner finds:
The system [of Iliff] first distinguishes patients by broadly
similar symptomology or complaint; e.g. all patients having a
headache, or all patients having chest pain, all patients having an
infection . . . . This first-level grouping is performed by using
expert rules and a decision flow diagram (e.g. Fig. 10a), both of
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which constitute “application of data mining techniques”. Then,
once the patients are distinguished by symptomology or
complaint, the system “distinguish[es] between patients that
need to see a physician immediately, and those that do not” based
on statistically-tuned sensitivity and specificity factors that are
particular to the symptomology or complaint; this step
constitutes categorizing the patients into two different subgroups
with similar symptom profiles through application of statistical
methods.
(Ans. 8, citing Iliff, col. 35, l. 31, to col. 36, l. 35 (FF 10–11).) We conclude
that Appellant has not adequately explained why the applied references fail
to suggest the method of claim 39.
Conclusion
The evidence supports the Examiner’s conclusion that Evers and Iliff
suggest the method of claim 30. We therefore affirm the obviousness
rejection of claim 30. Claims 31, 34–38, 49, 50, and 52–59 have not been
argued separately and therefore fall with claim 30. 37 C.F.R.
§ 41.37(c)(1)(iv).
The evidence also supports the Examiner’s conclusion that Evers and
Iliff suggest the method of claim 39. We therefore affirm the obviousness
rejection of claim 39. Claims 40 and 43–48 have not been argued separately
and therefore fall with claim 39.
In addition, the evidence supports the Examiner’s conclusion that
Evers and Iliff suggest the method of claim 32. We therefore affirm the
obviousness rejection of claim 32. For the same reasons, we affirm the
obviousness rejection of claims 41 and 51, which are similar to claim 32, but
depend from claims 39 and 49, respectively, and of claims 33 and 42, which
are not argued separate from claims 32 and 41, respectively.
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DOUBLE PATENTING
Appellants do not traverse any of the double patenting rejections,
whether statutory or obviousness-type. We therefore summarily affirm
them.
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).

AFFIRMED