Ex Parte Surwit et al

Patent Trial and Appeal Board

Dec 7, 2015

12793029 (P.T.A.B. Dec. 7, 2015)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
12/793,029 06/03/2010 Richard S. Surwit 9025-7CT2 5839
20792 7590 12/07/2015
MYERS BIGEL SIBLEY & SAJOVEC
PO BOX 37428
RALEIGH, NC 27627
EXAMINER
GILLIGAN, CHRISTOPHER L
ART UNIT PAPER NUMBER
3626
MAIL DATE DELIVERY MODE
12/07/2015 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 RICHARD S. SURWIT,
LYLE M. ALLEN III,
JAMES J. MORRIS JR.,
and THOMAS LEE ORTEL
___________

Appeal 2013–004033
Application 12/793,029
Technology Center 3600
___________

Before ANTON W. FETTING, BIBHU R. MOHANTY, and
PHILIP J. HOFFMANN, Administrative Patent Judges.
FETTING, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE1
Richard S. Surwit, Lyle M. Allen III, James J. Morris Jr., and Thomas
Lee Ortel (Appellants) seek review under 35 U.S.C. § 134 of a final
rejection of claims 1–18, 29–43, and 56–58, the only claims pending in the

1 Our decision will make reference to the Appellants’ Appeal Brief (“App.
Br.,” filed October 15, 2012) and Reply Brief (“Reply Br.,” filed January 15,
2013), and the Examiner’s Answer (“Ans.,” mailed December 18, 2012),
and Final Rejection (“Final Rej.,” mailed July 18, 2012).
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application on appeal. We have jurisdiction over the appeal pursuant to
35 U.S.C. § 6(b).
The Appellants invented a way of monitoring and modifying
anticoagulation therapy of remotely located patients. Specification 1:Title.
An understanding of the invention can be derived from a reading of
exemplary claim 56, which is reproduced below (bracketed matter and some
paragraphing added).
56. A method of
monitoring disease therapy of a patient,
wherein the disease therapy includes
a patient-administered medication regimen
and
a patient-administered regimen
for a test that monitors efficacy of the
medication regimen,
the method comprising the following steps:
[1] receiving information from a patient
at a portable, handheld apparatus
according to a first log on schedule2
that indicates that a disease condition of the patient has
changed;3

2 This phrase is ambiguous, potentially meaning either according to a first
log that is on a schedule, or according to a first schedule for logging on. The
Specification and prosecution history suggests the latter interpretation is
preferred.

3 It appears a comma is missing after the words “patient” and “schedule,” for
absent the commas, the limitation reads as though it is the schedule rather
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and
[2] directing the patient,
via the portable, handheld apparatus
to provide future information to the portable, handheld
apparatus
according to a second log on schedule
that is different from the first log on schedule
in response to receiving information from the patient that
a disease condition has changed.
The Examiner relies upon the following prior art:
Russek US 5,534,851 July 9, 1996
Gavin US 5,800,781 Sept. 1, 1998
Brown US 6,161,095 Dec. 12, 2000
Claims 56–58 stand rejected under 35 U.S.C. § 102(e) as anticipated by
Brown.
Claims 1–6, 8–15, 17, 18, and 29–43 stand rejected under 35 U.S.C. §
103(a) as unpatentable over Gavin and Brown.
Claims 7 and 16 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over Gavin, Brown, and Russek.

than the information “that indicates.” This would be inconsistent with the
second step.
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ISSUES
The issues of anticipation turn primarily on whether Brown’s treatment
regimen encompasses a treatment schedule. The issues of obviousness turn
primarily on whether the art describes prompting a patient to perform a test
in response to a severity assessment.
FACTS PERTINENT TO THE ISSUES
The following enumerated Findings of Fact (FF) are believed to be
supported by a preponderance of the evidence.
Facts Related to Claim Construction
01. The disclosure contains no lexicographic definition of
“schedule.”
02. The ordinary definition of “schedule” within the context of the
claims is a program of events or appointments expected in a given
time.4
Facts Related to the Prior Art
Brown
01. Brown is directed to interaction with a community of
individuals, relating to treatment regimen compliance and
efficacy, including supply and use of pharmaceuticals. Brown
1:20–22.

4 The American Heritage Dictionary of the English Language, Fifth Edition
2015 by Houghton Mifflin Harcourt Publishing
Companyhttps://www.ahdictionary.com/word/search.html?q=schedule.
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02. Brown uses a protocol or other intelligent message which acts
in place of a service provider and which is capable of collecting or
imparting information to patients in place thereof. Individuals
interact with the protocol or intelligent message to provide
assistance in all aspects of treatment regimen compliance, data
collection, supply or delivery, review, and modification. These
aspects can include (1) reminders regarding compliance with a
selected treatment regimen for medication, physical therapy,
psychological therapy, self-improvement, or some combination
thereof, (2) data collection of facts regarding patient compliance,
symptomology, possible drug interactions or side effects of
medication if required by the treatment regimen, and other facts
relevant to evaluation and possible modification of the treatment
regimen; (3) networked integration with workstations for medical
professionals to automate approvals and modifications, and refills
and delivery of medication if required by the treatment regimen.
Brown 2:53–3:6.
03. Brown’s service provider determines a treatment regimen for
selected patients, determines a protocol to be followed by the
client devices to assist the patient in complying with that treatment
regimen [in assisting with that medication regimen] and to
maximize effectiveness of treatment, and sends that protocol to
the server device. The server device can update (responsive to the
protocol) selected instructions at the client devices, and can
receive (responsive to selected instructions) information from the
client devices regarding their associated patients. Brown 3:7–17.
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04. Brown’s client device, located locally to a patient, couples to a
portable device capable of being carried away by the patient to
locations relatively remote from the client device. The client
device can interact with the portable device: (1) to provide the
portable device with the capability of reminding the patient
regarding the treatment regimen, or (2) to provide the portable
device with the capability of further data collection regarding the
patient. The client device can interact with the portable device
using a docking connection, an infrared connection, a radio-
frequency connection, a plug-in connection, or another suitable
connection. Brown 3:18–30.
05. After the treatment regimen and protocol information is
recorded in the memory, the portable device can be uncoupled
from the patient device and taken with the patient to locations
relatively or logically remote from the patient device. Whether
the portable device coupled or uncoupled to the patient device,
when the patient is due to perform an act according to the
treatment regimen, the portable device uses the presentation
element to provide a reminder message instructing the patient to
perform that act. Brown 5:24–34.
06. The patient performs the indicated act and enters a message into
the portable device confirming performance of the act using the
patient feedback input element. Operation of the patient feedback
input element causes the processor chip to cancel the reminder
message, check the clock, and record the time and fact of
performance in the memory. The patient also enters additional
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information relevant to monitoring and evaluating the treatment
regimen in response to queries by the presentation element in
accordance with the treatment regimen and protocol. Brown
5:24–34.
07. At some later time, the portable device is re-coupled to the
patient device using the coupling element, causing the contents of
the memory to be downloaded into the patient device and sent to
the server device for recording in the database. Such a time may
be as is convenient to the patient, or according to a selected
maximum time interval dictated by the treatment regimen and
protocol, or as is required to replenish the power source of the
portable device, or in accordance with other requirements of the
system. Brown 5:48–57.
08. Brown’s protocol or other intelligent message reviews and
compares the information provided by the patient to the
requirements of the treatment regimen in order to evaluate the
effectiveness of the treatment regimen towards achieving
treatment objectives and as to compliance of the patient with the
treatment regimen. The protocol may then leave the treatment
regimen unchanged or modify it as needed to increase
effectiveness and/or compliance; in either case, the server device
sends a message to the patient device as to the regimen to be
followed from that time forward. Brown 5:58–6:1.
09. When a treatment regimen requires a patient to take one or
more medications, the portable device can be coupled to a
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medication dispenser containing medication specified by the
treatment regimen. The portable device also controls the
medication dispenser so as to release only the correct dosage of
the correct medication at the correct time responsive to the
treatment regimen. The dispenser automatically provides
feedback to the portable device when the correct medication is
removed, canceling the reminder message and storing the
feedback for subsequent downloading to the patient device on the
next occasion that the portable device is coupled to the patient
device. Brown 6:15–28.
10. Responsive to the treatment regimen and protocol information
stored in the memory in conjunction with input from the clock,
Brown’s patient device uses the presentation element to provide a
reminder message to the patient that an act is required to be
performed by the patient and instructs the patient regarding the act
to be performed. The patient performs the indicated act as
directed. The patient operates the feedback input element on the
portable device, canceling the reminder message. The portable
device uses the presentation element to query the patient to
provide information responsive to the protocol for evaluating the
effectiveness of the treatment regimen. Brown 7:13–28.
11. The information received by Brown’s server device from the
patient device is evaluated by the protocol. Brown 7:49–52.
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Gavin
12. Gavin is directed to portable devices for performing blood
coagulation tests on blood such as a prothrombin time tests, and
the associated methods used to perform such tests. Gavin 1:18–
21.
13. Gavin describes a self[-]contained, portable device for
performing blood coagulation tests on a patient's blood. Blood is
first drawn from a patient using a lancet. The blood is then
supplied to a disposable cuvette placed within the testing device.
The blood is drawn into multiple conduits within the cuvette. In a
preferred embodiment, each of the conduits contain[s] a dried
prothrombin time reagent that is rehydrated by the blood. The
blood in each of the conduits is then reciprocally moved across a
restricted region until a predetermined degree of coagulation
occurs. Since the coagulation time is being monitored in multiple
conduits, a median coagulation time for a given sample can be
determined. Gavin 4:19–31.
14. Gavin describes determining the coagulation time for the blood
of a patient, especially a patient who is taking an anticoagulation
drug such as warfarin. The apparatus is a self-contained portable
testing instrument designed to provide a simple, user friendly
blood coagulation analysis, i.e. prothrombin time (PT) test, to
either the user or the user's physician. The apparatus consists of a
disposable cuvette and the actual testing device. A sample of
blood is placed within the cuvette, [which] is inserted into the
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testing device. The testing device tests the blood sample without
contacting the blood sample. Accordingly, once the PT test has
been completed, the cuvette can be removed from the testing
device and disposed. Another cuvette can then be entered into the
testing device without the need to sterilize or otherwise clean the
testing device. Gavin 5:45–65.
15. Gavin describes displaying either the results of a test just
preformed, or a historical analysis of previously stored test results.
Gavin 5:66–6:2.
16. Gavin describes retaining the results of at least ten different
tests in memory for a given patient. For any one given test, the
coagulation time result is compared to a predetermined maximum
value and a minimum value. If the test results fall outside the
acceptable range, a warning is displayed to make the patient
and/or the doctor aware of the danger. The test device can
download information stored in memory over the telephone. A
patient, using the test device at home, can thereby send test data to
a doctor or a hospital over the telephone. Gavin 11:48–59.
ANALYSIS
Claims 56–58 rejected under 35 U.S.C. § 102(e) as anticipated by Brown
We are not persuaded by the Appellants’ argument that “[m]odifying a
treatment regimen is not synonymous with directing a patient to provide
future information according to a second log on schedule that is different
from a first log on schedule.” App. Br. 7. As the Examiner found,
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Brown teaches that the times when the patient provides
feedback are dictated by the current treatment regimen and
protocol (see column 5, lines 48–57). The examiner considers
the times when a patient gives feedback to be encompassed by
the phrase “log on schedule.” Accordingly, when a patient
gives feedback at one time, they are giving feedback according
to a first “log on schedule.” When a patient then gives
feedback after the treatment regimen and protocol have been
updated/modified, they are giving feedback according to a
second, different “log on schedule.” As noted in Brown, the
second feedback is given at “some later time” according to “the
treatment regimen and protocol” (column 5, lines 48–57). The
claims fail to distinguish a first and second “log on schedule”
from a first and second “log on time.”
Ans. 4. Appellants respond that there is a distinction between a schedule
and a time. Reply Br. 1–2. Appellants fail to appreciate that the Examiner
is referring to the times in the regimens before and after regimen change.
Such a collection of times specified by each regimen is within the scope of a
schedule. Also, Brown’s change in regimen negates the Appellants’
contention that the before and after times could be the same schedule.
Whether the specific times are changed or unchanged from the first to
second regimen would be immaterial given the regimen itself changed.
We are not persuaded by the Appellants’ argument that “Brown is
wholly silent as to a second log on schedule that is in response to receiving
information from the patient that a disease condition has changed.” App. Br.
8–9 (emphasis omitted).
As the Examiner found
[a]n evaluation of the treatment regimen necessarily is an
indication of change in patient condition. For example, Brown
states that feedback information includes patient symptoms (see
column 2, line 66–column 3, line 3). The patient subsequently
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is directed to provide information at “some later time” (column
5, [lines] 48–57).
Ans. 4. As to Appellants’ response (Reply Br. 2–3), it is understood that
such an evaluation is only an indication of change when the evaluation
shows such a change, but when the evaluation shows the change, the
evaluation is such an indication. In particular, Brown changes the regimen
in response to such an evaluation.
Claims 1–6, 8–15, 17, 18, and 29–43 rejected under 35 U.S.C. § 103(a) as
unpatentable over Gavin and Brown
Claims 7 and 16 rejected under 35 U.S.C. § 103(a) as unpatentable over
Gavin, Brown, and Russek
Claim 1 is a more narrow form of claim 56, further reciting what the
patient data contains, assessing severity of the data, prompting the patient to
perform a coagulation test if the received patient data are assessed to be
above a threshold severity level, and receiving the results of that test. We
are persuaded by the Appellants’ argument that
Gavin merely performs a coagulation test on a patient's blood
without any consideration of the severity of other data received
from the patient. There is no data received from a patient prior
to a coagulation test. Furthermore, because no data is received,
there is no assessing of the severity of such data.
. . .
An apparatus and method for determining the coagulation time
for blood of a patient is not synonymous with receiving data
from a patient, wherein the patient data includes at least one of
physiological data, pathophysiological data, biological data,
psychological data, neuropsychological data, and behavioral
data, as recited in Claim 1. The step of receiving data from a
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patient recited in Claim 1 is separate and distinct from the step
“receiving coagulation test results from the patient-administered
test at the portable apparatus” recited in Claim 1.
. . .
Appellants respectfully submit that the Examiner is confusing
the two separately recited steps of receiving patient data and
receiving coagulation test results. Assuming that the cited
passage does disclose” assessing severity”, which Appellants
assert that it does not, the severity is in reference to coagulation
time data, not data received from a patient that includes at least
one of physiological data, pathophysiological data, biological
data, psychological data, neuropsychological data, and
behavioral data, as recited in Claim 1.
App. Br. 10–11, emphasis omitted.
The Examiner found,
Gavin teaches receiving patient data in the form of a
coagulation test result. A blood coagulation test result is
encompassed by the claimed patient data because it constitutes
physiological data, pathophysiological data, and biological data.
It appears that Applicant's argument against this teaching is
based on the fact that the claim has a separate step of “receiving
coagulation test results.” However, since a coagulation test
result is encompassed by the claimed “patient data,” this
argument is not found to be persuasive. Moreover, the system
of Gavin is designed to take multiple coagulation test results
over time (see column 11, lines 48–50). Accordingly,
considering a first coagulation test result to be the claimed
“patient data” and a second coagulation test result to be the
claimed “coagulation test results” is completely consistent with
the teachings of Gavin.
Ans. 5. Appellants responds that “Gavin merely performs a coagulation
test on a patient's blood without any consideration of the severity of other
data, whether that other data is coagulation test data or some other data
received from the patient.” Reply Br. 4, emphasis omitted.
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The Examiner makes no finding that either reference describes
prompting for the coagulation test in response to assessed severity. The
Examiner finds an assessment of severity and plural coagulation tests, but
makes no finding that the second test is in response to the assessment. The
Examiner finds that Brown describes altering a treatment regimen in
response to such an assessment, but performing a coagulation test is not
described as being part of a treatment regimen, as a coagulation test is just
that, a test, and not a part of treatment per se.
CONCLUSIONS OF LAW
The rejection of claims 56–58 under 35 U.S.C. § 102(e) as anticipated by
Brown is proper.
The rejection of claims 1–6, 8–15, 17, 18, and 29–43 under 35 U.S.C. §
103(a) as unpatentable over Gavin and Brown is improper.
The rejection of claims 7 and 16 under 35 U.S.C. § 103(a) as
unpatentable over Gavin, Brown, and Russek is improper.
DECISION
The rejection of claims 56–58 is affirmed.
The rejection of claims 1–18 and 29–43 is reversed.
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) (2011).

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AFFIRMED–IN–PART

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