Ex Parte Reuter

Patent Trial and Appeal Board

Dec 9, 2015

12094795 (P.T.A.B. Dec. 9, 2015)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/094,795 05/23/2008 James M. Reuter
24737 7590 12/11/2015
PHILIPS INTELLECTUAL PROPERTY & STANDARDS
P.O. BOX 3001
BRIARCLIFF MANOR, NY 10510
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
2005P0261 OWOUS 5539
EXAMINER
JIAN, SHIRLEY XUEYING
ART UNIT PAPER NUMBER
3769
NOTIFICATION DATE DELIVERY MODE
12/11/2015 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):
debbie.henn@philips.com
marianne.fox@philips.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JAMES M. REUTER
Appeal2013-003988
Application 12/094,795
Technology Center 3700
Before LYNNE H. BROWNE, JAMES J. MAYBERRY, and
JASON W. MELVIN, Administrative Patent Judges.
BROWNE, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
James M. Reuter (Appellant) appeals under 35 U.S.C. § 134 from the
Examiner's decision rejecting claims 2, 3, 7-11, 13, 15-17, 19, 20, and 28-
34.1 We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
CLAIMED SUBJECT MATTER
The claims are directed to a method and apparatus for remote patient
monitoring. Claim 7, reproduced below, is illustrative of the claimed subject
matter:
1 Claims 1, 4--6, 12, 14, 18, and21-27 are canceled.
Appeal2013-003988
Application 12/094,795
7. An apparatus comprising:
a medical device which measures physiological data from
a patient;
a patient terminal which receives the physiological data
from the medical device and transmits the physiological data;
a clinician terminal which receives manual inputs and
audio inputs; and
a server which receives the physiological data from the
patient terminal and inputs from the clinician terminal;
the server including a processor and being
configured to:
convert the manual and the audio inputs into
text and to transmit the text to the patient terminal
for display,
store the physiological data,
analyze the physiological data by comparing
the physiological data with (1) a first criteria
indicating a medically threatening physiological
condition and (2) a second criteria indicating that
the physiological data is flawed,
based on the analysis indicating the
medically threatening physiological condition,
transmit an alarm message to the patient terminal,
and
based on the analysis indicating that the
physiological data is flawed, transmit a check
monitor message to the patient terminal.
REFERENCES
The prior art relied upon by the Examiner in rejecting the claims on
appeal is:
Lavin
West
Schulze
US 5,772,585 June 30, 1998
US 2002/0013518 Al Jan. 31, 2002
US 2002/0019584 Al Feb. 14, 2002
2
Appeal2013-003988
Application 12/094,795
REJECTIONS
I. Claims 2, 3, 7, 8, and 28 stand rejected under 35 U.S.C. § 103(a) as
being unpatentable over Schulze, West, and Lavin.
II. Claims 9-11, 13, 15-17, 19, 20, 29-31, and 34 stand rejected under
35 U.S.C. § 103(a) as being unpatentable over Schulze and West.
III. Claims 32 and 33 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Schulze, West, as applied to claims 9 and 16, and
further in view of Lavin.
OPINION
Rejection I
Claims 7 and 28
The Examiner finds that the combined teachings of Schulze, West and
Lavin disclose or suggest all of the limitations of independent claim 7. In
particular, the Examiner finds that Schulze discloses a Host that analyzes
the physiological data by comparing the physiological data with
(1) a first criteria indicating a medically threatening
physiological condition ([O 114-115] alarm conditions triggered
physiological measurement falling out of threshold bounds) and
(2) a second criteria indicating that the physiological data is
flawed ([O 11 OJ criteria to set off an alert, i.e. sensor error; when
a sensor is off/broken/ disconnected, it inherently indicates that
the physiological data subsequently collected is flawed).
Final Act. 3--4 (emphasis added). In addition, the Examiner finds that West
discloses a primary central station. See id. at 5. Based on these findings the
Examiner determines that it would have been obvious "to modify Schulze
such that the data analysis software program resides in the Host." Id. at 5---6
(citing KSR Int'! Co. v. Teleflex, Inc., 550 U.S. 398, 421 (2007)).
3
Appeal2013-003988
Application 12/094,795
Appellant notes that Schulze fails to disclose a server that performs
the analysis. See Br. 9. Although Appellant's observation is correct, it is
not indicative of error, as the rejection is based on the combined teachings of
Schulze, West, and Lavin. Specifically, the rejection relies on West's
disclosure of analysis at a primary central station. Nonobviousness cannot
be established by attacking the references individually when the rejection is
predicated upon a combination of prior art disclosures. See In re Merck &
Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986).
Appellant then argues that "paragraph [0110] does not describe
analyzing the physiological data with a criteri[ on] that indicates that the
physiological data is flawed. Rather, paragraph [O 11 OJ only discloses
analyzing for medically threatening conditions and for the lack of signal due
to the sensor being OFF, broken, or disconnected." Br. 9.
We understand the Examiner to find that in Schulze' s apparatus, the
data continues to be collected from a sensor that is off, broken, or
disconnected. See Final Act. 4. Appellant does not contest this finding.
Rather, Appellant argues that in Schulze' s apparatus, the data collected is
not used by the processor in the manner claimed. However, a claim
containing a "recitation with respect to the manner in which a claimed
apparatus is intended to be employed does not differentiate the claimed
apparatus from a prior art apparatus" if the prior art apparatus teaches all the
structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647
(BP AI 1987). Here, Schulze discloses a processor that collects flawed data
as discussed, supra. The Examiner determines that Schulze' s processor is
capable of analyzing the flawed data in the manner claimed. See Ans. 11.
Appellant does not explain why Schulze' s processor could not be used to
perform the claimed analysis. Thus, Appellant does not apprise us of error.
4
Appeal2013-003988
Application 12/094,795
Appellant further argues that Schulze's teachings "refer to recoverable
alerts and system failures, particularly recoverable alerts," and as such,
"[t]here is no motivation to add the cost, complexity, and potential for
miscommunications by performing such a recoverable alert analysis at a
remote location." Br. 9; see also Br. 10 (West makes no suggestion that one
should move Schulze's functions of generating alerts indicative of a
detached or disconnected sensor, that the PDM is out of range, that the
battery is low, or that the memory of the PDM is full from the PDM to a
server).
Schulze's teachings are not so limited. As the Examiner correctly
finds, Schulze describes "[i]nstigating a specific audible sound phrase or
tone of the voice synthesizer can be done from a Host device. Such requests
can be used to alert the patient under unusual conditions. Such requests also
serve as diagnostic tools to ensure the PDM is working properly." Schulze
i-f 100; see also Final Act. 3. In Schulze, the Host is remote from the PDM.
Appellant does not explain why sending alerts from a server or other remote
location would involve more cost, complexity, or potential for
miscommunication than sending alerts from Schulze' s remote Host.
Moreover, Appellant's arguments are not responsive to the rejection as
articulated by the Examiner, because the rejection does not propose a
modification that would result in "all of the other malfunctioning
determinations [failing] when the PCM is out of range." Br. 10; see Final
Act. 4---6. Thus, Appellant's argument is not convincing.
In addition, Appellant argues that "Schulze teaches against analyzing
the physiological data at the server" and directs our attention to Schulze's
paragraphs 21 and 22. Id. These paragraphs state:
5
Appeal2013-003988
Application 12/094,795
It is still another objective of the present invention to
provide automatic testing and troubleshooting functions for the
physiological monitoring device.
It is a further objective of the present invention to
accomplish all the above objectives using a device that is worn
by the patient in a relatively unobtrusive fashion.
Schulze i-fi-1 21 and 22.
Appellant's argument is unconvincing because "teaching away"
requires that the reference "criticize, discredit, or otherwise discourage" the
use of other alternatives. See In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir.
2004 ). Here, the portions of Schulze cited by Appellant do not appear to
criticize, discredit, or otherwise discourage analysis of physiological data at
a server. We will not read into a reference a teaching away from a proposed
combination when no such language exists. See Dystar Textilfarben GmbH
& Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1364 (Fed. Cir.
2006).
For these reasons, we sustain the Examiner's decision rejecting claim
7. Appellant does not present separate arguments for the patentability of
claim 28 which depends from claim 7. Accordingly, we likewise sustain the
Examiner's decision rejecting claim 28.
Claims 2 and 3
Claim 2 requires a "patient terminal comprises a stationary patient
device and a remote patient device configured to communicate with the
server via the stationary patient device." Br. 17.
Appellant argues that "[p ]aragraph [0032] of Schulze, contrary to the
Examiner's assertion, does not relate to the transmission of data. Rather,
paragraph [0032] of Schulze indicates that the PDM can be connected to a
personal computer for advanced servicing." Br. 11.
6
Appeal2013-003988
Application 12/094,795
Paragraph 32 states:
The PDM also comprises circuitry for self-testing its
various sub-systems and sensors and for communicating any
trouble shooting information directly to the patient in the event
that the sensor becomes dislodged, for example. Further, such
trouble-shooting data can also be sent in a wireless mode to the
central server such that trouble-shooting can take place
remotely, or in the alternative, a new PDM unit can be sent to
the patient. The patient may further connect the PDM to a
personal computer (PC) for advanced servicing performed by a
technician at a remote location.
Schulze i-f 32.
Clearly, paragraph 32 relates to the transmission of data in the context
of trouble shooting the PDM. Accordingly, Appellant's argument is not
convmcmg.
We sustain the Examiner's decision rejecting claim 2. Appellant does
not present separate arguments for the patentability of claim 3 which
depends from claim 2. Accordingly, we likewise sustain the Examiner's
,..l • • • • 1 • 'J uec1s1on rejectmg c1aim .J.
Claim 8
Claim 8 requires "physiological data further include[ing] a time and a
date, and the physiological data received by the server is analyzed for signal
quality." Br. 18.
The Examiner finds that Schulze "teaches wherein the physiological
data further includes a time and a date." Final Act. 7 (citing Schulze i-f 105).
The Examiner further finds that "Schulze monitors 'signal quality' by
analyzing physiological parameters and determining an alert status as a
result of bad signal from malfunctioning sensors." Ans. 13 (citing Schulze
i-fi-1 134 and 116).
7
Appeal2013-003988
Application 12/094,795
Schulze paragraph 105 states:
The timekeeping mechanism for determining when a
measurement recording is to take place is the Real-Time Clock
(R TC) that provides time 48. Each stored record of
measurements contains a time stamp and the current internal
status of the PDM.
Schulze i-f 105. Schulze paragraph 116 states:
Alerts relate to sensor errors or device hardware
warning/malfunction. Alerts are used to inform the patient that
the system is not operating properly and that corrective action is
required[.] If an alert is in force for a measured parameter, then
any alarms associated with the parameter are not allowed to
activate. There are two classes of alerts; (1) recoverable and (2)
system failures[.]
Schulze i-f 116. Schulze paragraph 134 states:
The PDM further monitors its own internal status. The
PDM records: (1) the status of measurement systems (active,
disabled, etc.); (2) alarm status for each measurement system;
(3) alert status; (4) current operation mode; (5) current profile in
force; ( 6) communication signal status; and (7) recording
memOf'J status. Status \~1ill be preseP1ed during po\~1er-do\~1n
periods and restored on subsequent Power-On. This
preservation requirement extends to abnormal power-down
situations as well, such as an accidental power disconnection.
Schulze i-f 134.
One skilled in the art would understand a time stamp from a Real-
Time Clock includes the date. Therefore, the Examiner correctly finds that
Schulze discloses physiological data including a time and date. Final Act. 7.
Neither paragraph 116 nor paragraph 134 describes analyzing the
physiological data for signal quality; however, claim 8 is an apparatus claim.
Therefore, the limitation "the physiological data received by the server is
analyzed for signal quality" is merely a statement of how the physiological
data, in particular the signal status portion of the physiological data, is
8
Appeal2013-003988
Application 12/094,795
intended to be used. As discussed supra, the manner in which the signal
status data is intended to be used does not patentably distinguish the claim.
For these reasons, we sustain the Examiner's decision rejecting
claim 8.
Rejection II
Claims 9-11, 13, 15, and 29
The Examiner finds that the combined teachings of Schulze and West
disclose or suggest all of the limitations of claim 9. Final Act. 7-11.
Appellant's arguments with respect to claim 9 are essentially the same
as the arguments presented regarding claim 7. Appellant again argues that
Schulze's "paragraph [0110] refers to determinations made [at] the PDM,
not the server." Br. 12. As discussed supra, Appellant's argument is not
persuasive, because West, not Schulze, is relied upon to meet the limitations
directed to a server. See Final Act. 10.
Appellant's argument that "paragraph [0110] does not describe
determmmg whether physiological state or other data is inaccurate" (Br. 12)
does not take into consideration the Examiner's finding, discussed supra,
that in Schulze data continues to be collected even if a sensor is turned off,
broken, or has become disconnected. Thus, Appellant's argument is not
convincing because it is not responsive to the rejection as articulated by the
Examiner. Further, Appellant's statement that "Schulze determines proper
functioning of the PDM at the PDM, not the server" (Br. 13) is factually
incorrect as discussed, supra.
For these reasons, we sustain the Examiner's decision rejecting
claim 9. Appellant does not present separate arguments for the patentability
of claims 10, 11, 13, 15 and 29 which depend from claim 9. Br. 13.
Accordingly, we sustain the Examiner's decision rejecting these claims.
9
Appeal2013-003988
Application 12/094,795
Claims 16 and 19
Appellant essentially repeats the same arguments for claim 16 as
previously presented for claims 7 and 9, and these arguments are not
persuasive for the reasons discussed supra.
We sustain the Examiner decision rejecting claim 16. Appellant does
not present separate arguments for the patentability of claim 19 which
depends from claim 16. We sustain the Examiner's decision rejecting claim
19.
Claim 17
Claim 17 requires "a second interface which transmits the action
message to a clinician terminal." Br. 21. Appellant argues that Schulze fails
to disclose a second interface. Br. 14.
In response to this argument, the Examiner determines that "the claim
does not specify that the first and second interfaces are different. Therefore,
the broadest reasonable interpretation provides that the first and second
interfaces may be the same or different." Ans. 15.
The Examiner's analysis is in error. By specifying first and second
interfaces, the claim requires different interfaces. We do not sustain the
Examiner's decision rejecting claim 17.
Claim 20
Claim 20 requires "vital signs data includ[ing] an elapsed time to
acquire measurement data from the medical device and a time of day and a
date of a measurement from the medical device." Br. 22.
Appellant argues that "Schulze wants to only measure the data
periodically. The profiles determine what this interval is. Significant by its
absence in these paragraphs is any suggestion that a periodicity to acquire
the measurement data is incorporated into the vital signs data." Br. 14.
10
Appeal2013-003988
Application 12/094,795
In response to this argument, the Examiner explains that Schulze has
"operation profiles which include schedules of START and STOP times for
detecting each physiological parameter; this is sufficient to reject an elapsed
time as claimed." Ans. 15 (citing Schulze i-f 124). Paragraph 124 states:
Each profile contains a control block made up of multiple
parameters. The following parameters and rules set comprise
one embodiment of parameters, but is not meant to be a
limitation. A Start and Stop Time is set in minutes. A Periodic
Posting Period is set in minutes. The Periodic Posting Period is
the periodic interval in which the PDM will attempt to post data
to the Host Site. An Enable/Disable switch is set for each
measurement system. Disable means that the particular
measurement system will be put to sleep entirely while the
profile is in force. A Measurement Interval Time (in seconds)
is provided for each measurement system run by the PDM.
This interval time determines the length of time between a
measurement recording session. A Measurement Duration
Time (in seconds) is set for each measurement system. For
example, the ECG measurement may be data logged every 20
minutes for a measurement duration of 30 seconds. For this
example, the measurement duration is set to 30 and the interval
is set to 1200 seconds.
Schulze i-f 124.
Appellant is correct. Although, the profiles contain start and stop
times, they are files in the PDM and do not pertain to the vital signs data.
We do not sustain the Examiner's decision rejecting claim 20.
Claim 30
Claim 30 requires "medical devices include[ing] a scale which weighs
the patient and the central server generates a check scale message in
response to patient weight changing by more than a threshold amount." Br.
22-23.
11
Appeal2013-003988
Application 12/094,795
Appellant argues that "[p ]aragraph [0040] indicates that weight could
be monitored, but makes no suggestion of error messages based on weight."
Id. at 15. Appellant further argues that "[p]aragraph [0174] indicates that
the PDM can interface with external devices. Again, paragraph [0174]
makes no suggestion of a check scale message, much less the generation of a
check scale message in response to patient weight changing by more than a
threshold amount." Id. Appellant is correct.
We do not sustain the Examiner's decision rejecting claim 30.
Claim 31
Claim 31 requires, inter alia, that the processor analyze "the vital
signs data with an algorithm which determines whether each message is to
be sent to the patient, the clinician, or both." Br. 23.
Appellant argues that "the host 30 of Schulze does not perform an
analysis on vital signs data to determine whether to send a message to the
patient, the clinician, or both." Id. at 15. Appellant is correct.
We do not sustain the Examiner's decision rejecting claim 31.
Claim 34
Claim 34 requires analysis of the "signal quality of the vital signs data
provided by the medical devices." Br. 23. Appellant raises essentially the
same arguments for claim 34 as presented for claim 8. These arguments are
not persuasive for the reasons discussed supra.
We sustain the Examiner's decision rejecting claim 34.
Rejection III
Appellant does not present any separate arguments for the
patentability of claims 32 and 33. Br. 13, 14. We sustain the Examiner's
decision rejecting claims 32 and 33.
12
Appeal2013-003988
Application 12/094,795
DECISION
The Examiner's rejections of claims 2, 3, 7-11, 13, 15, 16, 19, 28, 29,
and 32-34 are AFFIRMED.
The Examiner's rejections of claims 17, 20, 30, and 31 are
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)(l )(iv).
AFFIRMED-IN-PART
mls
13