Ex Parte Hatlestad et al

Board of Patent Appeals and Interferences

Jul 26, 2012

10323616 (B.P.A.I. Jul. 26, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________________
Ex parte JOHN HATLESTAD, JEFFREY E. STAHMANN,
and QINGSHENG ZHU
____________________

Appeal 2011-001394
Application 10/323,616
Technology Center 3600
____________________

Before: BIBHU R. MOHANTY, MEREDITH C. PETRAVICK, and
MICHAEL W. KIM, Administrative Patent Judges.

KIM, Administrative Patent Judge.

DECISION ON APPEAL

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STATEMENT OF CASE
Appellants appeal under 35 U.S.C. § 134 from a rejection of claims 1-
10, 12-15, 17-27, and 29-39. We have jurisdiction under 35 U.S.C. § 6(b).
The claims are directed to an advanced patient management for
triaging health-related data (Spec. 1:26-27). Claim 1, reproduced below, is
illustrative of the claimed subject matter:
1. A method for use in managing a patient’s health within a
patient management system where the patient management
system includes an Implantable Medical Device (IMD)
configured to be implanted in an ambulatory patient, a device in
a clinical setting for use by a clinician, and a portable external
device configured to communicate with the IMD and
configured to remotely communicate with the device in the
clinical setting when the ambulatory patient is away from the
clinical setting, the method comprising:
identifying at least two events from a plurality of
predetermined events related to the patient’s health using the
patient management system, including:
acquiring at least one health-related parameter using the
IMD; and
using the at least one health-related parameter acquired
using the IMD to identify at least one of the
events;
automatically prioritizing processing of the identified
events, including classifying the identified events according to a
severity level selected from a plurality of levels of severity,
wherein a first level of severity is less severe than a second
level of severity; and
automatically triggering a system action within the
patient management system based on the classified severity for
the identified events,
wherein automatically prioritizing and automatically
triggering are performed in the IMD or the portable external
device.
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REFERENCES
The prior art relied upon by the Examiner in rejecting the claims on
appeal is:
Lee
Weisner
Shabot
Chan
Haller
US 4,838,275
US 5,262,944
US 5,942,986
US 2001/0039503 A1
US 2002/0052539 A1
Jun. 13, 1989
Nov. 16, 1993
Aug. 24, 1999
Nov. 8, 2001
May 2, 2002
Soll
Sheldon
US 2003/0055679 A1
US 6,937,899
Mar. 20, 2003
Aug. 30, 2005

REJECTIONS
Claims 1, 2, 4, 6, 8-10, 12, 14, 29-34, and 37-38 are rejected under 35
U.S.C. § 103(a) as being unpatentable over Haller in view of Lee and
Sheldon.
Claim 3 is rejected under 35 U.S.C. § 103(a) as being unpatentable
over Haller in view of Lee, Sheldon, and Examiner’s Official Notice.
Claims 5 and 7 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Haller in view of Lee, Sheldon, and Weisner.
Claim 13 is rejected under 35 U.S.C. § 103(a) as being unpatentable
over Haller in view of Lee, Sheldon, and Shabot.
Claims 15 and 17-27 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Haller in view of Lee.
Claim 35 is rejected under 35 U.S.C. § 103(a) as being unpatentable
over Haller in view of Lee, Sheldon, and Chan.
Claims 36 and 39 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Haller in view of Lee, Sheldon, and Soll.
We AFFIRM.
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ISSUES
Did the Examiner err in asserting that a combination of Haller, Lee,
and Sheldon renders obvious independent claim 11?
Did the Examiner err in asserting that a combination of Haller, Lee,
and Sheldon renders obvious dependent claim 2?
Did the Examiner err in asserting that a combination of Haller, Lee,
and Sheldon renders obvious dependent claim 4?
Did the Examiner err in asserting that a combination of Haller, Lee,
and Sheldon renders obvious dependent claims 29-31?
Did the Examiner err in asserting that a combination of Haller, Lee,
and Sheldon renders obvious dependent claim 32?
Did the Examiner err in asserting that a combination of Haller, Lee,
and Sheldon renders obvious dependent claims 33-34, 37, and 38?
Did the Examiner err in asserting that a combination of Haller, Lee,
Sheldon, and Official Notice renders obvious dependent claim 3?
Did the Examiner err in asserting that a combination of Haller, Lee,
Sheldon, and Weisner renders obvious dependent claims 5 and 7?
Did the Examiner err in asserting that a combination of Haller, Lee,
Sheldon, Chan, and Soll renders obvious dependent claims 35, 36, and 39?

1 We choose independent claim 1 as representative of claims 1, 15, and 17-
27, as for claims 15 and 17-27, Appellants’ sole argument is that
“Appellants [traverse] for the same reasons provided in claim 1” (App. Br.
28-29). See 37 C.F.R. § 41.37(c)(1)(vii).
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FINDINGS OF FACT
We adopt the Examiner’s findings of fact, as set forth on pages 3-25
of the Examiner’s Answer.

ANALYSIS
Independent Claim 1
We are not persuaded the Examiner erred in asserting that a
combination of Haller, Lee, and Sheldon renders obvious independent claim
1 (App. Br. 17-22). Appellants assert that Lee does not disclose either an
IMD or an external device, as recited in independent claim 1 (App. Br. 17-
18, 21). However, Haller and Sheldon are cited for disclosing IMDs
(Exam’r’s Ans. 4-5, 21-22). See In re Merck & Co., 800 F.2d 1091, 1097
(Fed. Cir. 1986) (the argument that a single reference alone does not disclose
the recited claimed steps is not persuasive because nonobviousness cannot
be established by attacking the references individually when the rejection is
predicated upon a combination of prior art disclosures); In re Keller, 642
F.2d 413, 426 (CCPA 1981) (“one cannot show non-obviousness by
attacking references individually where, as here, the rejections are based on
combinations of references”).
Appellants further assert that Sheldon does not disclose prioritizing
processing of identified events, as recited in independent claim 1(App. Br.
18, 21). However, Lee is cited for disclosing such prioritizing (Exam’r’s
Ans. 5, 21-22). See In re Merck & Co., 800 F.2d at 1097.
Appellants also assert that the “Office’s statement fails to identify or
consider a subject for performing the act [and]… fails to identify and
consider an object on which the act is performed” (App. Br. 18-21).
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Appellants then provide the examples of the different kinds of “driving” and
“flying” to illustrate their point. While we understand Appellants’
argument, we do not believe it is analogous to the current situation because
(1) regardless of the subject, the function of Lee is performed in the same
manner, and (2) the objects in Lee and Haller are the same. Specifically,
Lee is cited for disclosing prioritizing severity of incoming medical events
(object) (Exam’r’s Ans. 5, 21-22). While it is true that it is an observer
(subject), and not the recited IMD or external device (subject), performing
the prioritizing in Lee, Haller is cited for disclosing an IMD that receives
incoming medical events (object) (Exam’r’s Ans. 4, 21-22). Accordingly,
since Lee and Haller disclose the same incoming medical events (object),
and regardless of whether the subject is the IMD or observer, the prioritizing
function is performed in the same manner, we agree with the Examiner that
such a substitution was obvious. A similar rationale would apply for the
triggering, where both Haller and Sheldon have the same subject (an IMD)
and object (the patient), and Sheldon accepts a severity of medical condition
input, which would include the severity level from Lee, and then triggers an
appropriate response. Thus, we agree with the Examiner that Sheldon would
also perform its same function in the asserted combination.
Appellants additionally assert that
[t]he functions performed by Lee and Sheldon are not the same.
Sheldon does not select an ischemia therapy based on the vital
signs in Lee, and the vital signs in Lee do not function to
provide the location of the ischemic tissue and the severity of
the ischemic condition, a selection of the type of therapy as well
as the location for delivery of the therapy
(App. Br. 21). However, as both references are in the medical condition
detection and treatment field, we agree with the Examiner that one of
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ordinary skill would be able to adapt the symptoms and severity outputs of
Lee for the ischemic inputs of Sheldon.

Dependent Claim 2
We are not persuaded the Examiner erred in asserting that a
combination of Haller, Lee, and Sheldon renders obvious dependent claim 2
(App. Br. 22-24). Appellants assert that
[t]he Office states that Haller responds to classifying the
event at the first or second level of severity. However, the
Office previously stated that Haller does not classify the
identified event according to a severity level (page 3 lines 17-20
of the Final Office Action). Therefore, the Office is
inconsistent with its own statements. Haller cannot respond to
classification of the level of severity, as argued by the Office
(App. Br. 22). We admit that, on its own, the Examiner’s rejection of
dependent claim 2 is a bit confusing. However, when taken in conjunction
with the rejection of independent claim 1, it is clear that the combination of
Haller, Lee, and Sheldon set forth in independent claim 1 is meant to render
obvious “classify[ing] the identified event according to a severity level,” and
that the additionally cited portions of Haller in this rejection are meant to
correspond to the additional aspects set forth in dependent claim 2.
Appellants further assert that “[t]he Office failed to provide a
reference or other objective evidence showing the ‘manual’ activity that is
just being automated” so as to be performed on the IMD or portable external
device, as recited in independent claim 1 (App. Br. 22-23). The above
analysis concerning independent claim 1 is also applicable here.
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Appellants then recite the aspects set forth in dependent claim 2, but
do not provide additional arguments as to why the Examiner’s rejection is in
error (App. Br. 23-24).

Dependent Claim 4
We are not persuaded the Examiner erred in asserting that a
combination of Haller, Lee, and Sheldon renders obvious dependent claim 4
(App. Br. 24). Specifically, Appellants assert that “Lee does not
‘automatically trigger’ within an IMD or external device within a patient
management system” (Id.). However, Haller and Sheldon are cited for
disclosing the automatic triggering (Exam’r’s Ans. 4-6, 21-23). See In re
Merck & Co., 800 F.2d at 1097.

Dependent Claim 12
We are not persuaded the Examiner erred in asserting that a
combination of Haller, Lee, and Sheldon renders obvious dependent claim
12 (App. Br. 24-25). Appellants assert that because the Office asserts that
“Haller does not classify the identified event according to a severity level…
Haller cannot respond to classification of the level of severity, as argued by
the Office” (App. Br. 24). However, Lee is cited for disclosing the
classification, Sheldon is cited for disclosing an action selection in response
to the classification, and Haller is cited for disclosing the actions (Exam’r’s
Ans. 21-23). See In re Merck & Co., 800 F.2d at 1097.

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Dependent Claims 29-31
We are not persuaded the Examiner erred in asserting that a
combination of Haller, Lee, and Sheldon renders obvious dependent claims
29-31 (App. Br. 25-26). Appellants assert that
[t]he Office asserts with respect to claims 29-31 that Lee
teaches many events that could be associated with acute heart
failure decompensation. The Office has not shown that Lee
associates the “vital signs” with acute heart failure
decompensation. The Office relies on low cardiac output,
weight gain, or heart rate increase classified at many different
priority levels. As recognized by the Office, these vital signs
have different priority levels. It is unclear how one event has
multiple priority levels. Thus, it is clear that these vital signs in
Lee do not represent an event associated with acute heart failure
decompensation
However, dependent claim 29 recites “automatically assigning an event
associated with acute heart failure decompensation to the second level of
severity.” As the Examiner has identified events in column 18 of Lee that
are associated with acute heart failure decompensation, and at least some of
those events are at severity levels 2 and 4 (depending on which level is the
higher severity level on Lee’s scale of 1 to 5), the claim aspect is met.
For dependent claims 30 and 31, Appellants only repeat claim
language. Accordingly, Appellants have not met the burden of rebutting the
Examiner’s prima facie case (Exam’r’s Ans. 9). See In re Keller, 642 F.2d
413, 425 (CCPA 1981) (“[o]nce a prima facie case of obviousness [is]
established..., the burden shift[s] to appellant to rebut it”).

Dependent Claim 32
We are not persuaded the Examiner erred in asserting that a
combination of Haller, Lee, and Sheldon renders obvious dependent claim
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32 (App. Br. 26). Appellants only repeat claim language, and thus have not
met the burden of rebutting the Examiner’s prima facie case (Exam’r’s Ans.
9-10). See In re Keller, 642 F.2d at 425.

Dependent Claims 33-34, 37, and 38
We are not persuaded the Examiner erred in asserting that a
combination of Haller, Lee, and Sheldon renders obvious dependent claims
33-34, 37, and 38 (App. Br. 26). Appellants assert that “[t]he Office relies
on paragraph 155 of Haller. However, this paragraph does not show the use
the recited parameters to identify the event. Paragraph 155 indicates that
there is a response to an event” (Id.). However, paragraph 155 of Haller
specifically recites “a detected physiologic event,” which would have been
identified based on input parameters such as “vital signs of patient.”

Dependent Claim 3
We are not persuaded the Examiner erred in asserting that a
combination of Haller, Lee, Sheldon, and Official Notice renders obvious
dependent claim 3 (App. Br. 27). Appellants assert that they timely
traversed the Examiner’s Official Notice. However, neither page 19 of the
Amendment After Final filed January 19, 2010, nor page 27 of the Appeal
Brief, specifically point out the supposed errors in the Examiner’s taking of
Official Notice, “includ[ing] stating why the noticed fact is not considered to
be common knowledge or well-known in the art. See 37 CFR § 1.111(b).”
MPEP § 2144.03(C). An adequate traverse must contain adequate
information or argument to create on its face a reasonable doubt regarding
the circumstances justifying Examiner’s notice of what is well known to one
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of ordinary skill in the art. See In re Boon, 439 F.2d 724, 728 (CCPA 1971).
Accordingly, the Examiner’s Official Notice still stands.
Appellants then assert that the Official Notice “does not identify the
subject of object of this act,” and that “neither physician to physician
communication, nor Lee show an IMD or external device within a patient
management system that automatically triggers the system action recited in
the claim” (App. Br. 27). For this, we adopt the same analysis set forth
above with respect to independent claim 1.

Dependent Claims 5 and 7
We are not persuaded the Examiner erred in asserting that a
combination of Haller, Lee, Sheldon, and Weisner renders obvious
dependent claims 5 and 7 (App. Br. 27-28). We admit that, on its own, the
Examiner’s rejection of dependent claims 5 and 7 is a bit confusing.
However, when taken in conjunction with the rejection of independent claim
1, it is clear that the combination of Haller, Lee, and Sheldon set forth in
independent claim 1 is meant to render obvious “classify[ing] the identified
event according to a severity level,” and that the additionally cited portions
of Haller in this rejection are meant to correspond to the additional aspects
set forth in dependent claims 5 and 7.
Appellants then recite the aspects set forth in dependent claim 2, but
do not provide additional arguments as to why the Examiner’s rejection is in
error.

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Dependent Claims 35, 36, and 39
We are not persuaded the Examiner erred in asserting that a
combination of Haller, Lee, Sheldon, Chan, and Soll renders obvious
dependent claims 35, 36, and 39 (App. Br. 29-30). Appellants assert that
neither Chan nor Soll remedy the deficiencies in the Examiner’s rejection of
independent claim 1. However, as set forth above, the Examiner’s rejection
of independent claim 1 is not deficient.

DECISION
The Examiner’s rejection of claims 1-10, 12-15, 17-27, and 29-39 is
AFFIRMED.
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).

AFFIRMED

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